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IRB Coordinator
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Position Title
: IRB Coordinator 
Reports To
: IRB Manager 
Status
: Non-Exempt 
Remote Position but must reside in TX, WI, OH, IL, IN, MD, MI, MO
SUMMARY
: Under the direction and guidance of the IRB Manager, this position provides administrative support to the Manager, IRB members, clients, investigators, and study personnel. 
ESSENTIAL DUTIES AND RESPONSIBILITIES
: Other duties may be assigned as needed. 
- Ensures compliance with Federal Regulations, ICH Guidelines, Standard Operating Procedures (SOPs), and company policies
 - Provides procedural guidance to board members, team members and clients
 - Coordinates activities associated with the planning, facilitating, and follow-up of convened IRB meetings, IRB action items and expedited review items such as:
 - Processing of: initial protocol, new investigators, continuing review, protocol amendments, consent form document revisions, recruiting materials, protocol deviations, investigator non-compliance, etc., within the established turnaround time
 - Attends and facilities multiple weekly IRB meetings
 - Actively participates in the Board meeting to ensure Board review and discussion of all agenda items and ensures the meeting minutes are accurately recorded, as specified by Salus IRB policy and procedures
 - Reviews study documents submitted for IRB review and completes appropriate checklists
 - May assist with day-to-day expedited review requests from clients such as minor ICD revisions and recruiting/study materials
 - Communicates effectively with clients, staff members, board members, investigators, and study personnel to identify and resolve issues, responding to inquiries in a professional and timely manner
 - Prepares and finalizes IRB meeting agendas and minutes, and ensures action items are processed and communicated to the client accordingly
 - Ensures all agenda items requiring follow-up are appropriately documented on the meeting minutes and are followed through to resolution within the established timeline
 - Tracks and maintains IRB submissions in the database
 - Ensures all study documents are filed in a timely manner and study files are maintained in accordance with company policy
 - May coordinate study document translations working directly with the vendor
 - Performs data entry, photocopying, scanning or posting documents to GlobeSync, the web-based document distribution system
 - May assist in training of new employees
 - May attend educational conferences
 
QUALIFICATIONS:
To perform in this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION AND/OR EXPERIENCE:
1. BA/BS degree preferred
2. At least two years experience supporting IRB activities or clinical trials experience preferred. Will consider other industry or related experience
3. Working knowledge and interpretation of all IRB-related regulations preferred
4. Industry certification or willing/able to obtain certification within one year of hire is preferred
KNOWLEDGE, SKILLS AND ABILITIES:
1. Excellent organizational and oral/written communication skills
2. Detail oriented; ability to provide accurate client deliverables in a fast-paced, deadline driven environment
3. Must be self-motivated with proven ability to prioritize and handle multiple tasks effectively and accurately
4. Ability to establish priorities and respond promptly to a large variety of requests and needs, in a fast-paced and deadline driven environment
5. Successfully works independently and within a team
6. Successfully applies problem solving and critical thinking skills
7. Knowledge and application of MS Office Suite and other web-based programs
To perform the job successfully, an individual should demonstrate the following competencies:
Customer/Client service – Manages difficult or stressful client situations; responds promptly to client needs, solicits client feedback to improve service; responds to requests for service and assistance.
Organization – Prioritizes and plans work activities and uses time efficiently; assists in setting goals and objectives.
Language ability – Ability to read, analyze, and interpret general business documents, SOPs, regulatory documents, technical procedures, and IRB-related; writes business correspondence independently; speaks effectively and presents information and ideas clearly; responds concisely and efficiently to questions.
SUPERVISORY RESPONSIBILITIES:
None.
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IRB Coordinator
Posted today
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Job Description
Job Description
About Vitalief 
Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably.
The Role 
We are seeking an experienced IRB Coordinator to join our exceptional team as a full-time Vitalief employee. In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities.
WHY VITALIEF?   
- Contribute to advancing scientific discoveries that improve patient lives.
 - PEOPLE FIRST culture with opportunities for growth and innovation.
 - Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans.
 - Market-competitive salary , commensurate with experience.
 
Work Location: 100% on-site (8am to 4pm M-F) in Livingston, NJ.
Responsibilities:
- Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications.
 - Review protocol submissions for completeness and accuracy; recommend appropriate level of review.
 - Draft and issue correspondence reflecting IRB deliberations and decisions.
 - Provide regulatory and methodological guidance to investigators, staff, students, and IRB members.
 - Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations.
 - Manage IRB databases, tracking systems, and protocol documentation.
 - Assist with emergency use protocols and special meetings as needed.
 - Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items.
 - Collaborate with other system IRB Coordinators and departmental staff.
 - Stay current on regulatory and legislative developments through conferences and professional training.
 
Qualifications:
- Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred.
 - Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience.
 - Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines.
 - Excellent written and verbal communication skills.
 - Ability to demonstrate professionalism, clear communication, and respect in all interactions.
 - Passionate in supporting teamwork and collaborative problem-solving.
 - Apply continuous quality improvement principles to research operations.
 - Work independently with accountability, sound judgment, and openness to feedback.
 - Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects.
 - Detail-oriented with strong organizational and follow-up skills.
 - Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred.
 - Certified IRB Professional (CIP®) is a plus.
 - Knowledge of medical terminology preferred.
 
PHYSICAL DEMANDS:  Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. 
IMPORTANT NOTE:  Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. 
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                    IRB Coordinator Consultant
Posted today
Job Viewed
Job Description
Job Description
About Vitalief 
Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably.
The Role 
We are seeking an experienced IRB Coordinator Consultant to join the Vitalief team as a contractor.  In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities.
Engagement Details  
- Work Hours: 40 hours per week (8am to 4pm M-F)
 - Work Location: 100% on-site in Livingston, NJ.
 - Contract Duration: 6 months (possible extension)
 - Pay Rate: Market competitive (depends on experience level)
 
- Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications.
 - Review protocol submissions for completeness and accuracy; recommend appropriate level of review.
 - Draft and issue correspondence reflecting IRB deliberations and decisions.
 - Provide regulatory and methodological guidance to investigators, staff, students, and IRB members.
 - Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations.
 - Manage IRB databases, tracking systems, and protocol documentation.
 - Assist with emergency use protocols and special meetings as needed.
 - Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items.
 - Collaborate with other system IRB Coordinators and departmental staff.
 - Stay current on regulatory and legislative developments through conferences and professional training.
 
Qualifications:
- Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred.
 - Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience.
 - Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines.
 - Excellent written and verbal communication skills.
 - Ability to demonstrate professionalism, clear communication, and respect in all interactions.
 - Passionate in supporting teamwork and collaborative problem-solving.
 - Apply continuous quality improvement principles to research operations.
 - Work independently with accountability, sound judgment, and openness to feedback.
 - Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects.
 - Detail-oriented with strong organizational and follow-up skills.
 - Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred.
 - Certified IRB Professional (CIP®) is a plus.
 - Knowledge of medical terminology preferred.
 
PHYSICAL DEMANDS:  Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. 
IMPORTANT NOTE:  Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. 
#LI-DNP 
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                    IRB Training Coordinator, Division of Research & Innovation
Posted 8 days ago
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Job Description
Wayne State University is searching for an experiencedIRB Training Coordinator, Division of Research & Innovationat its Detroit campus location.
Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich, high-quality education. Our deep-rooted commitment to excellence, collaboration, integrity, diversity and inclusion creates exceptional educational opportunities which prepare students for success in a global society.
Position Purpose:
TheInstitutional Review Board(IRB)Training Coordinatoris the primary educator and informational resource for the research community, Institutional Review Board members, faculty, and staff responsible for various educational activities related to the Wayne State University (WSU) Institutional Review Board.
Essential Functions:
Monitor changing regulatory landscape, assisting in writing IRB policies and procedures to remain current with regulatory requirements and guidance. Responsible for assuring that all educational materials, tools, and resources are in strict compliance with federal and state regulations and Institutional policies governing human research and are reflected in the policies and forms. Develop and maintain educational materials, documents, resources and tools for the research community, IRB members, and IRB staff to aid in understanding all interactions with the IRB and regulatory bodies.
In collaboration with the Associate Director, Director, IRB Administration Operations management, maintain IRB policies and procedures and IRB forms. Assist with preparing for audits by federal regulatory agencies, regulatory bodies, and accreditation bodies (Food and Drug Administration, Office for Human Research Protection, AAHRPP, VA, etc.).
Association for Accreditation of Human Research Protection Programs: AAHRPP Re-Accreditation work begins every 4-5 years which shifts this % time during that period making this function category more like 30% and shifting the first 2 categories listed down to 10% where education activities are focused refreshers on AAHRP standards.
Develop and maintain a comprehensive education program for the protection of human participants in research. Convey investigator responsibilities of IRB and regulatory reporting to the research community to maintain and promote compliance at WSU.
Develop, maintain, and deliver IRB trainings on a variety of topics at a variety of locations and times, associated with IRB submissions, review, and approval of human research protocols. Develop and deliver individual sessions for faculty, affiliates, staff, and students who wish to conduct human participant research. Coordinate with various academic units to develop and conduct training programs unique to their fields.
Process Human Participant Research Determinations and Administrative Application. Assist with Single Time Use Processing and Submission Pre-reviews.
Conduct investigator training as directed by the Institutional Review Board (IRB). Develop, coordinate, and deliver trainings and educational materials for IRB members, prospective IRB members and IRB staff as directed.
Other duties as assigned.
Minimum Qualifications:
Education: Bachelor's degree
Bachelor's degree from an accredited college or university or equivalent experience in the field of research compliance or research regulatory support.
Experience: Experience (minimum 2 years of job-related experience)
Minimum of 2 to 5 years' experience with Institutional Review Boards, ethics board procedures, and research submission methods and procedures. 3 years' experience in IRB, research field, or similar.
Some knowledge of psychological, pharmaceutical, medical and/or drug agency research.
1 to 3 years' experience teaching preferred.
CIP certification is preferred.
Knowledge, Skills, and Abilities:
Advanced written, oral, and interpersonal communication skills.
Strong prioritization, organizational, and analytical skills.
In depth knowledge of federal, state, and local regulations regarding the protection of humans in research.
Ability to negotiate/mediate with a variety of professionals including scientists and physician investigators, and a diverse research community.
Strong customer service skills and ability to work independently in a deadline-driven environment.
Strong understanding of all the technical terminology involved in the work to decide which research projects and protocols need to be discussed.
Knowledge and experience with University policies, procedures and practices surrounding the approval of research.
Knowledge of and ability to proficiently use a PC and computer-based applications.
Attention to detail and ability to continuously multi-task in a fast-paced work environment is essential to succeed in this position.
Ability to establish and meet deadlines, work under extreme pressure and function independently.
Ability to work occasional evenings and early mornings, as needed by research community for presentations, etc.
School/College/Division:
H09 - Research
Primary department:
H0955 - Human & Animal Resource Compliance
Employment type:
+ Regular Employee
+ Job type: Full Time
+ Job category: Staff/Administrative
Funding/salary information:
+ Compensation type: Annual Salary
+ Annual Salary: To be Determined
Working conditions:
Normal office environment. Some evening work is required.
Job openings:
+ Number of openings:1
+ Reposted position:Yes
+ Reposted reason:Extended Search Opportunity
+ Prior posting/requisition number:Req 2115
Background check requirements:
University policy requires certain persons who are offered employment to undergo a background check, including a criminal history check, before starting work. If you are offered employment, the university will inform you if a background check is required.
Equal employment opportunity statement:
Wayne State University provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, national origin, religion, age, sexual orientation, familial status, marital status, height, weight, disability, veteran status, or any other characteristic protected by applicable law. The university welcomes applications from persons with disabilities and veterans. Wayne State is an equal opportunity employer.
The university welcomes applications from persons with disabilities and veterans. Wayne State is an equal opportunity employer.
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                    Research Administration- Manager, Clinical Trials Team- School of Medicine
                        Posted 4 days ago
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Job Description
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community.
**Description**
KEY RESPONSIBILITIES:
+ Reporting to the Research Administration Services (RAS) Director, manages, leads, and supervises all staff performing pre-award and/or post-award clinical trials activities for the sponsored projects research portfolio for an assigned department, division or school.
+ Manages a small portfolio of Clinical Trials Monitors.
+ Oversees, evaluates, and reviews staff performing pre-award and/or post-award clinical trials activities, and ensures quality of performance and customer service to
+ Addresses and resolves issues that deviate from established RAS performance level agreements.
+ Assists departmental faculty/Principal Investigators (PIs) and clinical trials coordinators in developing, preparing, and submitting clinical trial proposals.
+ Coordinates and reviews proposal elements, such as biosketches facilities and resources, for consistency, accuracy, and completeness.
+ Monitors and facilitates proposal process through the routing process in compliance with University procedures and institutional signatures.
+ Upon award acceptance/contract execution, defines account establishment parameters, including billing and reporting requirements, budgets, and cost sharing obligations.
+ Requests subcontracts, and facilitates approvals for invoices and monitors payments to subcontractors.
+ Reviews and manages budgets, and completes financial reports for sponsors, as required by clinical trial terms and conditions.
+ Coordinates and submits requests, as necessary, for No Cost Extensions, Carryover, rebudgeting requests, and changes in scope, in compliance with sponsor guidelines and University policies.
+ May review effort reports and manage quarterly effort certification processes for assigned units.
+ Supervises day-to-day operations of Clinical Trials Specialists, including monitoring of workload distribution and tasks, as appropriate.
+ Provides guidance to team members, as appropriate.
+ Works with Pre-Award and/or Post-Award Team Leads to coordinate and collaborate on work endeavors.
+ Performs related responsibilities as required.
MINIMUM QUALIFICATIONS:
+ Bachelor's degree and five years work-related clinical trials management OR an equivalent combination of education, training and experience.
+ Supervisory experience preferred.
+ Knowledge of federal rules and regulations and sponsor requirements related to research grants and contracts, specifically clinical trials.
+ Proficiency with MS Office Suite.
NOTE: Tasks related to this position can be performed remotely with only occasional visits to an Emory University location. Eastern (EST) time zone business hours may apply. Emory reserves the right to change this status with notice to employee. Emory does not approve as a primary work location in the following states; NJ, AK, and HI, any U.S. Territories or outside of the United States.
**Additional Details**
Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: (V) | (TDD).
Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at or call (Voice) | (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.
**Connect With Us!**
Connect with us for general consideration!
**Job Number** _ _
**Job Type** _Regular Full-Time_
**Division** _School Of Medicine_
**Department** _SOM: Cancer RAS_
**Job Category** _Clinical Research_
**Campus Location (For Posting) : Location** _US-GA-Atlanta_
**_Location : Name_** _Emory Campus-Clifton Corridor_
**Remote Work Classification** _Full Remote - Monthly_
**Health and Safety Information** _Not Applicable_
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                    Manager Research Administration
Posted 3 days ago
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                    Research Administrator, Post Award III - Pediatrics Research Administration Services - Clinical T...
                        Posted 4 days ago
Job Viewed
Job Description
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community.
**Description**
JOB DESCRIPTION:
+ Supports the day-to-day activities of a team of Post-Award Specialists. Monitors workload distribution and raises any concerns to the Research Administration Services (RAS) director.
+ Provides guidance to team members, as appropriate.
+ Coordinates with RAS Director regarding pre-award activities, issues resolution, and workload distribution.
+ Ensures strong levels of customer service to faculty and departments being served.
+ Works with Pre-Award team lead to coordinate inter-team meetings to facilitate collaboration between the pre-award and post-award teams, as necessary and appropriate.
+ Manages post-award activities within a RAS unit in support of an assigned portfolio of grants and contracts within one or more units (i.e., school, department, division, institute, or center) using knowledge of grant and contract management rules and regulations, technical expertise, and analytical skills.
+ Post-award activities include regular review, reconciliation, and projection of award finances, preparing adjustments and corrections to award budgets, preparing financial reports, and at the end of the award, ensuring all financial requirements have been met and closing out the award.
+ Interacts regularly with and provides high quality customer service to faculty members conducting sponsored research.
+ Ensures adherence to quality standards and all policies and award regulations.
+ Creates high-quality written reports.
+ Upon award acceptance, defines account establishment parameters, including billing and reporting requirements, budget, and cost sharing obligations.
+ Sets up award in financial system.
+ Distributes award information to PIs, co-PIs and relevant staff and other RAS units.
+ Coordinates with relevant individuals to make adjustments to payroll for all budgeted positions (including relative cost sharing positions).
+ Reviews and reconciles award expenditures and budgets, making adjustments, as necessary.
+ Projects and forecasts future award expenditures.
+ Manages budget, reporting and compliance timelines through the lifecycle of the grant or contract.
+ Communicates with PIs on a regular basis regarding budget and expense adjustments and revisions.
+ Completes financial reports to be sent to sponsor, as required by the award terms and conditions.
+ Monitors compliance with agency and University regulations regarding reporting.
+ Completes invoice and submits to sponsor (for certain award types only).
+ Assists PIs with non-financial report submissions, as necessary.
+ Coordinates and submits requests for No Cost Extensions, Carryover, rebudgeting requests, changes in scope, and other changes to the award; ensures all requests are done in compliance with sponsor guidelines and University policies.
+ Facilitates the approval of invoices to pay subcontractors.
+ Reviews effort reports and manages quarterly effort certification process for assigned units.
+ Applies federal and university rules to management of effort allocation appropriately for individuals compensated whole or in part from federal awards.
+ Assists in transferring awards out of the university.
+ Closes out all funded projects consistent with university process and timelines.
+ Performs related responsibilities as required.
MINIMUM QUALIFICATIONS:
+ Bachelor's degree and five years of experience related to grants and contracts management OR an equivalent combination of education, training and experience.
+ Knowledge of federal rules and regulations/terms and conditions relating to research grant and/or contract activity.
+ Knowledge of the PeopleSoft Financial System preferred.
PREFERRED QUALIFICATIONS:
+ Clinical trials experience preferred.
NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University location as needed and at times, on short notice. Emory reserves the right to change this status with notice to employee.
#LI-VJ1
**Additional Details**
Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: (V) | (TDD).
Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at or call (Voice) | (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.
**Connect With Us!**
Connect with us for general consideration!
**Job Number** _ _
**Job Type** _Regular Full-Time_
**Division** _School Of Medicine_
**Department** _SOM: Pediatrics RAS_
**Job Category** _Research Administration_
**Campus Location (For Posting) : Location** _US-GA-Atlanta_
**_Location : Name_** _Emory Campus-Clifton Corridor_
**Remote Work Classification** _Primarily Remote - Monthly_
**Health and Safety Information** _Not Applicable_
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                    Clinical Trials Coverage Analyst (Research Administration - Galveston) Medical billing and coding
                        Posted 3 days ago
Job Viewed
Job Description
**Galveston, Texas, United States**
Research Academic & Clinical
UTMB Health
Requisition #
**EDUCATION & EXPERIENCE**
**Minimum Qualifications:**
Bachelor's degree or equivalent, five years of related experience.
**Preferred Qualifications:**
+ Experience in clinical research, ideally with a background in clinical research medical billing and coding
**JOB SUMMARY**
Provides centralized administrative review of clinical trial agreements, study protocols, informed consent documents, and budgets to ensure Principal Investigators and other billing entities comply with federal and state regulations for clinical research billing.
**Scope:** **_NA_**
**ESSENTIAL JOB FUNCTIONS**
**Job Duties:**
+ Determine whether proposed clinical trials qualify as defined in all relevant national coverage decisions.
+ Acts as a resource and assists Principal Investigators, study coordinators, and budget analysts in determining that all costs for clinical studies are included in the study budget and are appropriate and/or accurate.
+ With input from the principal investigators and study coordinators, the proper allocation of items and services between routine and research costs is determined, and methods are set up to bill accordingly. This responsibility includes the following tasks: ensuring budget worksheets identify appropriate billing parties, reviewing financial agreements with UTMB contracts specialists and, if necessary, collaborating entities, and ensuring financial consistency between research agreements and study protocols.
+ Ensures that relevant sections of the informed consent document conform to CMS billing rules.
+ Assists in mandatory training courses for faculty and personnel involved in clinical research when necessary.
+ Coordinates the development of Standard Operating Procedures (SOPs) for all entities involved with clinical research billing.
+ Assists in the development of monitoring plans for billing-related activities.
+ Generates billing grids with applicable CPT and/or other codes in the Institution's Clinical Trial Management System.
+ Remains knowledgeable and up to date with current FDA and Medicare guidelines for clinical trial billing
+ Maintains a complete portfolio of accounts receivable throughout the revenue cycle, including charge review, account work queues, claim edits, and claim submission.
+ Reviews charges in Epic and Epic-generated reports to identify standard-of-care, research-related, or indeterminate services.
+ Follows federal and state regulations to ensure compliance standards are met.
+ Review research patient accounts to ensure research charges are routed appropriately.
+ Communicate with Revenue Cycle teams, payors, and others to resolve account discrepancies or errors.
+ Participates in meetings, as needed, to address potential payor concerns
+ Other duties as assigned
+ Adheres to internal controls and reporting structure.
+ Performs related duties as required.
**Knowledge/Skills/Abilities:**
+ Working knowledge of Epic and OnCore systems
+ Communication skills
+ Problem-solving skills
+ Critical Thinking
**LICENSES, REGISTRATIONS OR CERTIFICATIONS**
**Required:** **NA**
**Preferred:** **NA**
**SUPERVISION**
**_NA_**
**WORKING ENVIRONMENT/EQUIPMENT**
The standard office environment at UTMB's main campus is Galveston.
**Salary Range:**
Commensurate with experience
**Equal Employment Opportunity**
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.
Compensation
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Assistant Director, Research Administration
                        Posted today
Job Viewed
Job Description
**Dean of Research, Stanford, California, United States**
**New**
Finance
Post Date 4 days ago
Requisition #
**SCHOOL/UNIT DESCRIPTION:**
The Ginzton Laboratory houses the research operations of 20 Principal Investigators, 25 staff scientists, 200+ graduate students, 35 post docs, 35 support staff and numerous visitors. The Ginzton Laboratory is an interdisciplinary research lab that explores the most exciting and productive areas at the overlap between engineering and the sciences. The combination of science and engineering gives new concepts, understanding, and rigor from science, the stimulus of challenging and important problems from engineering, and the depth of engineering technology to enable advanced scientific experiments. Strong opportunities come from the overlap of three scientific and engineering fields - quantum science and engineering, photonic science and engineering, and nanoscience and engineering. These are embedded in an environment that encourages and explores applications from other fields, such as sensing, communications, information processing, biology and medicine, energy, and the environment.
**POSITION SUMMARY:**
Ginzton Laboratory has an exciting opportunity to join our research administration and financial management team. We are seeking an Assistant Director, Research Administration to work under general supervision of the Managing Director to oversee a high performing team of grant administrators to support the proposal preparation and post award activities on grants, contracts, federal and non-federal grants, both routine and complex.
This position is responsible for ensuring compliance with sponsor and university policies and guidelines by implementing and maintaining policies within the grant management group, as well as providing training, mentorship and support for direct reports. This position will direct the sponsored research team in overseeing the entire life cycle of awards. This includes financial forecasting and reporting, interpreting, and communicating department, university and sponsor processes and policy, reviewing and approving financial transactions, reviewing expenditure statements and providing guidance and direction in escalations and complex scenarios. This position serves as a department resource on research administration and develops strong collaborations with faculty, staff, and both internal and external partners.
This is a busy position requiring a high level of professionalism, leadership, productivity, accuracy, initiative, sound judgement and decision making, attention to detail and follow-through. We are seeking an experienced professional in grant management with a background in pre and post award management, a very strong customer-service and work ethic, excellent communication and technical skills, a collaborative problem-solver, and who interacts well with all levels in a culturally diverse population. This position will manage five other research administrator team members who directly support the financial portfolio of 20 active faculty members and emeriti. We welcome you to apply to work on our team of engaged and collaborative team members who strive for continued growth to be the best we can be.
**CORE DUTIES:**
+ Manage the work of other employees, make hiring decisions, provide coaching and mentoring, manage performance, contribute to succession planning within area of responsibility.
+ Establish overall objectives or direction for a unit, project, or operational area. Plan, direct, and monitor all budgets for areas of responsibility, and manage business operation and administration of a functional unit or area; may lead a team in providing post award sponsored research administration and services.
+ Identify and resolve complex issues which may span multiple areas, apply ingenuity and creativity to problem analysis and resolution.
+ Oversee report preparation and analysis requiring the consolidation of multiple, complex financial and statistical data points.
+ Communicate financial policies and procedures; ensure accuracy, completeness, and timeliness for management financial processes and reports.
+ Collaborate with other colleagues on cross functional projects; contribute to solutions that may affect policy changes or the development of new controls or processes.
+ Participate in critical analysis of existing systems, policies, and procedures; recommend and implement approved solutions.
+ Contribute to projects in work area or unit; make decisions determining approach to managing and completing processes.
+ Represent the unit within the functional unit or school and to external constituencies
**MINIMUM REQUIREMENTS:**
**Education & Experience:**
Bachelor's degree and six years relevant experience or combination of education and relevant experience.
**Knowledge, Skills and Abilities:**
+ Advanced knowledge of Microsoft Office Suite
+ Knowledge of Oracle or other business financial systems.
+ Solid understanding of financial principles.
+ Advanced oral and written communication skills.
+ Ability to clearly and effectively present information to internal and external audiences, and all levels of management.
+ Strong analytical skills to review and analyze complex financial information.
+ Strong leadership and management skills with previous experience managing people, delegating workload and providing direction/corrections as necessary.
+ Knowledge of property management requirements related to Stanford or non-Stanford title of equipment and fabrications.
+ Demonstrated competency in project management of a high volume of work, some of which is cyclical.
+ If managing sponsored projects, ability to manage post and pre award administration for sponsored projects within his/her unit. Knowledge and fluency of governmental regulations and completion of Cardinal Curriculum level I and II.
+ Knowledge of procurement needs, including sole-sourcing, cost analyses, vendor requirements, and small business reporting.
+ Demonstrated experience working successfully with PIs, their administrative staff, and the office of sponsored research and external sponsors.
+ Demonstrated success in performing meticulous, high quality and compliant work.
+ Ability to interpret complex research and fiscal policies, assimilate information from a wide range of resources and act like a mentor and resource to others.
**PHYSICAL REQUIREMENTS*:**
+ Constantly perform desk-based computer tasks.
+ Frequently stand/walk, sitting, grasp lightly/fine manipulation.
+ Occasionally use a telephone
+ Rarely lift, carry, push, and pull objects weighing 11-20 pounds.
_* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job._
**WORKING CONDITIONS:**
+ May work flexible/hybrid work schedule.
**WORK STANDARDS:**
+ Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
+ Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
+ Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, expected pay range for this position is $146,116 to $165,219 per annum.
Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on a wide range of factors that are unique to each candidate including but not limited to geographic location, knowledge, skills and abilities, relevant education, depth and breadth of experience, performance; as well as other business and organization needs such as (but not limited to) the scope and responsibilities of the position, the minimum qualifications, departmental budget availability, and market and internal equity across the unit, department and reporting relationships.
At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.
**Why Stanford is for You**
Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Ourcultureandunique perksempower you with:
+ **Freedom to grow.** We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
+ **A caring culture.** We provide superb retirement plans, generous time-off, and family care resources.
+ **A healthier you.** Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
+ **Discovery and fun.** Stroll through historic sculptures, trails, and museums.
+ **Enviable resources.** Enjoy free commuter programs, ridesharing incentives, discounts and more!
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.
Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting acontact form.
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
Additional Information
+ **Schedule: Full-time**
+ **Job Code: 4456**
+ **Employee Status: Regular**
+ **Grade: J**
+ **Requisition ID: **
+ **Work Arrangement : Hybrid Eligible**
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                    Associate Director Research Administration (Research Finance) - #Staff
                        Posted 4 days ago
Job Viewed
Job Description
The Associate Director Research Administration provides leadership in training, direction, and management of a team of grants, subawards, and/or contracts analysts. The role may oversee or manage teams engaged in pre-award and/or post-award functions, such as proposal preparation, documentation review, portfolio management, workload assessments, process improvements, and workflow coordination. The Associate Director may also serve as a support resource for the pre-award and post-award teams during periods of increased workload, staff absences, or vacancies.
**Specific Duties & Responsibilities**
+ Supervise staff who perform the primary transactional actions related to grants, subawards, and/or contracts.
+ Provide expert advice to faculty and staff regarding sponsored projects and related activities.
+ Provide regulatory and compliance oversight and guidance to research administration staff related to university policies and procedures and all applicable rules, regulations, and sponsor guidelines. Monitor risk and compliance concerns.
+ Implement systems to track research administration reporting and metrics as well as sponsored projects deadlines and activity.
+ Project and analyze long-term trends in total research funding and sponsored effort across the division.
+ Monitor and manage staff onboarding and ongoing training and ensure processes are effective. Ensure that effective ongoing training programs are in place for all key positions and processes supporting research administration, including developing and participating in training/guidance of students, staff, and faculty in understanding university and sponsor policies and regulations as well as the systems that support sponsored projects.
+ Participate in institutional committees for research compliance and sponsored programs administration across the University.
+ Create and implement policies and procedures to address new regulatory changes in alignment with university, federal, and other sponsor guidelines.
+ Serve as a research administration ombudsperson for faculty and staff by providing leadership and guidance in support of sponsored projects.
+ Participate in long-range and strategic planning related to policy, organizational structure, process, outreach, and professional growth and development of staff. In coordination with leadership, assess gaps and overlaps in business processes and lead efforts to analyze and streamline processes to improve organizational metrics, performance, and service levels, and ensure consistency across the division.
+ Other duties as assigned.
_In addition to the duties described above_
+ Oversee strategic direction and provide operational leadership of the Nursing Office of Research Administration ("NORA") team. Develop annual goals for the NORA team that align with the SON strategic plan.
+ Ensure timely responses to requests for research administration support from SON leadership, faculty, University administration, and sponsors.
+ Ensure sound fiscal management of the sponsored research portfolio including pre- and post-award management of grants, contracts, and subcontracts - both domestic and foreign.
+ Monitor the JHU Sponsored Research dashboards and Effort Reporting System (ERP) reporting functions on a regular basis for timeliness of cost transfers, effort reporting, invoices, reports, and other deliverables. Escalate potential issues to the Associate Dean of Finance and Administration along with a plan for prevention or resolution.
+ Represent the Associate Dean for Finance and Administration / Vice Dean for Research in their absence.
**Minimum Qualifications**
+ Master's Degree in a related field.
+ Seven years of progressively responsible directly related experience.
+ Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
**Preferred Qualifications**
+ PhD or JD in related field and relevant specialized training.
+ Experience in sponsored projects, contracts and/or research compliance administration experience.
**Technical Skills & Expected Level of Proficiency**
+ Contract Negotiation - Advanced
+ Grant Regulations - Advanced
+ Interpersonal Skills - Advanced
+ Policy Development and Implementation - Advanced
+ Process Improvement - Advanced
+ Research Administration Knowledge - Advanced
+ Research Administration Training - Advanced
+ Stakeholder Engagement - Advanced
+ Strategic Planning - Advanced
_The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs._
Classified Title: Associate Director Research Administrati
Job Posting Title (Working Title): Associate Director Research Administration (Research Finance)
Role/Level/Range: ATP/04/PG
Starting Salary Range: $99,800 - $75,000 Annually ( 137,400 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday - Friday 8:30 - 5:00
FLSA Status: Exempt
Location: Hybrid/School of Nursing
Department name: Research Finance
Personnel area: School of Nursing
The listed salary range represents the minimum and maximum Johns Hopkins University offers for this position, based on a good faith estimate at the time of posting. Actual compensation will vary depending on factors such as location, skills, experience, market conditions, education, and internal equity. Not all candidates will qualify for the highest salary in the range.
Johns Hopkins provides a comprehensive benefits package supporting health, career, and retirement. Learn more: Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
EEO is the Law
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                    Research Assistant (Research Administration) - #Staff
Posted 3 days ago
Job Viewed
Job Description
The Research Assistant oversees data collection, data organization, and/or data management or similar functions/tasks for research study(ies) in support of a PI or a research team.
**Specific Duties & Responsibilities**
+ Run routine and ad hoc reports.
+ Use standard tools and computer programs to review data.
+ Assist with data cleaning measures to ensure accuracy of data and preparation of tables.
+ Lead basic activities such as data collection and data entry.
+ May lead specific tasks and develop processes to ensure study activities occur effectively and efficiently.
+ May conduct literature searches to support faculty in research efforts.
+ May design and format papers/publications.
+ May assist PIs in writing summaries of papers for release as policy briefs or other channels.
+ Other duties as assigned.
_In addition to the duties described above_
+ Recruitment and outreach to study participants.
+ Enroll study participants.
+ Administer informed consent with participants.
+ Conduct in person interviews with study participants.
+ Flexibility in scheduling is required to accommodate participants' schedules.
+ Participate in team meetings, presenting research findings and contributing to scientific discussions.
+ Contribute to writing and publishing research papers, conference abstracts, and grant proposals.
+ May lead specific tasks and develop processes to ensure study activities occur effectively and efficiently.
+ Design and set up standard operating procedures.
+ Oversee data collection.
+ Analyze data under general oversight and make data-driven recommendations.
+ Other study-related tasks.
**Minimum Qualifications**
+ Bachelor's Degree in a related field.
+ Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
**Preferred Qualifications**
+ Master's Degree.
+ Collaborative and with strong relationship-building skills.
+ Organized, efficient and detail oriented.
+ Able to handle multiple tasks and assignments.
+ Independent learner and worker.
+ Flexible and adaptable.
+ Ability to follow protocols, policies, and procedures and respond appropriately when presented with novel situations.
**Technical Skills & Expected Level of Proficiency**
+ Analytical Skills - Awareness
+ Attention to Detail - Awareness
+ Data Management and Analysis - Awareness
+ Formatting and Layout Proficiency - Awareness
+ Information Gathering - Awareness
+ Oral and Written Communications - Awareness
+ Organizational Skills - Awareness
_The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs._
**Classified Title** : Research Assistant
Role/Level/Range: ACRO40/E/03/CD
**Starting Salary Range** : $17.20 - $0.30 HRLY ( 23,441 targeted; Commensurate w/exp.)
Employee group: Casual / On Call
**Schedule** : Monday - Friday (up to 27 hours per week)
FLSA Status: Non-Exempt
**Location** : Hybrid/School of Nursing
Department name: Research Administration
Personnel area: School of Nursing
The listed salary range represents the minimum and maximum Johns Hopkins University offers for this position, based on a good faith estimate at the time of posting. Actual compensation will vary depending on factors such as location, skills, experience, market conditions, education, and internal equity. Not all candidates will qualify for the highest salary in the range.
Johns Hopkins provides a comprehensive benefits package supporting health, career, and retirement. Learn more: Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
EEO is the Law
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