Investigator Initiated Trial Specialist - Clinical Trials

11794 Stony Brook, New York Stony Brook University

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Investigator Initiated Trial Specialist - Clinical Trials
**Position Summary**
The Cancer Clinical Trials Office **Investigator Initiated Trial Specialist** is an independent, organized, and detail-oriented professional who collaborates closely with investigators and the IIT Manager. The Investigator Initiated Trial Specialist provides operational support and regulatory management for investigator-initiated clinical research at Stony Brook Cancer Center. Additionally, this role contributes to the design, training, implementation, and regulatory compliance of research projects. Key responsibilities include creating and managing data collection forms and databases, overseeing document versioning, and coordinating with cross-functional research staff across multiple sites.
**Duties of an Investigator Initiated Trial Specialist include but are not limited to:**
+ Providing administrative oversight of IIT study progress, including drafting administrative sections of research protocols, case report forms, consent forms, and other study documents.
+ Supporting investigators with FDA correspondence to ensure compliance with federal regulations for institutionally or Principal Investigator (PI)-held Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
+ Creating Institutional Review Board (IRB) submissions and managing correspondence across research sites, particularly in single-IRB/multi-site studies.
+ Planning and implementing changes to the research plan in collaboration with the PI and study team.
+ Collaborating with investigators and biostatisticians to ensure data collection meets the objectives of the studies and to create clinical study reports as needed.
+ Working with management to develop Standard Operating Procedures (SOPs), Work Instructions, and Forms.
+ Coordinating operations, data collection, and research staff training at each protocol site.
+ Assisting investigators with protocol disclosures, such as those required for clinicaltrials.gov and the Clinical Trials Reporting Program.
+ Identifying and reporting unanticipated problems to the PI, study team, IRB, FDA, and Data Safety Monitoring Committee (DSMC), as applicable.
+ Assisting in the development of study budgets in collaboration with the IIT and Finance Managers.
+ Collaborating with Quality Assurance programs during research audits and monitoring.
+ Attending and actively participating in Clinical Research Team meetings.
+ Maintaining research practices in accordance with Good Clinical Practice (GCP) guidelines, ensuring strict patient confidentiality as per HIPAA regulations and applicable law, and ensuring compliance with all federal and local agencies, including the FDA and local IRB.
**Qualifications:**
**Required** **:**
+ Bachelor of Science or other advanced healthcare degree
+ At least 3 years of experience with clinical studies in a healthcare setting
+ Knowledge and experience in regulatory guidelines and requirements for the conduct of clinical trials
+ Proficiency in Microsoft Office applications
**Preferred** **:**
+ Master's Degree or PhD in a related field
+ Additional experience in clinical research, including medical writing
+ ACRP/SOCRA certification (or equivalent)
+ Experience with multi-site studies
+ Familiarity with industry partners (e.g., pharmaceutical companies, CROs, central laboratories)
+ Experience with IND/IDE submissions to the FDA
+ Knowledge of policies and procedures governing clinical research and research subject protection, including US Federal Regulations, FDA guidelines, International Council for Harmonisation, Good Clinical Practices, HIPAA, NCI, and NIH regulatory and research disclosure requirements
**Special Notes** **:** **Resume/CV should be included with the online application.**
**Posting Overview** **:** This position will remain posted until filled or for a maximum of 90 days. An initial review of all applicants will occur two weeks from the posting date. Candidates are advised on the application that for full consideration, applications must be received before the initial review date (which is within two weeks of the posting date).
If within the initial review no candidate was selected to fill the position posted, additional applications will be considered for the posted position; however, the posting will close once a finalist is identified, and at minimal, two weeks after the initial posting date. Please note, that if no candidate were identified and hired within 90 days from initial posting, the posting would close for review, and possibly reposted at a later date.
______________________________________________________________________________________________________________________________________
+ Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.
+ All Hospital positions may be subject to changes in pass days and shifts as necessary.
+ This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
+ This function/position maybe designated as "essential." This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities.
**Prior to start date, the selected candidate must meet the following requirements:**
+ Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services
* + Complete electronic reference check with a minimum of three (3) professional references.
+ Successfully complete a 4-panel drug screen
* + Meet Regulatory Requirements for pre-employment screenings.
+ Provide a copy of any required New York State license(s)/certificate(s).
**Failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.**
***The hiring department will be responsible for any fee incurred for examination** .
_____________________________________________________________________________________________________________________________________­­
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
**If you need a disability-related accommodation, please call the University Office of Equity and Access at ( .**
**_In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed_** **_here_** **_._**
**Visit our** **WHY WORK HERE** **page to learn about the total rewards we offer.**
Stony Brook University Hospital, consistent with our shared core values and our intent to achieve excellence, remains dedicated to supporting healthier and more resilient communities, both locally and globally.
**Anticipated Pay Range:**
The salary range (or hiring range) for this position is $80,458 - $04,040 / year.
The above salary range represents SBUH's good faith and reasonable estimate of the range of possible compensation at the time of posting. The specific salary offer will be based on the candidate's validated years of comparable experience. Any efforts to inflate or misrepresent experience are grounds for disqualification from the application process or termination of employment if hired.
Some positions offer annual supplemental pay such as:
+ Location pay for UUP, CSEA & PEF full-time positions ( 3400)
Your total compensation goes beyond the number in your paycheck. SBUH provides generous leave, health plans, and a state pension that add to your bottom line.
**Job Number:** 2502106
**Official Job Title:** : TH Instructional Support Specialist
**Job Field** : Other
**Primary Location** : US-NY-Stony Brook
**Department/Hiring Area:** : Cancer Clinical Trials
**Schedule** : Full-time
**Shift** : Day Shift **Shift Hours:** : 9:00 AM - 5:00 PM **Pass Days:** : Sat, Sun
**Posting Start Date** : May 30, 2025
**Posting End Date** : Aug 28, 2025, 11:59:00 PM
**Salary:** : 83,858 - 107,440 / Total
**Salary Grade:** : SL3
**SBU Area:** : Stony Brook University Hospital
**Req ID:** 2502106
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Administrative Support Assistant - Cancer Clinical Trials

11794 Stony Brook, New York Stony Brook University

Posted 2 days ago

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Administrative Support Assistant - Cancer Clinical Trials
**Position Summary**
The **Administrative Support Assistant** for the Cancer Clinical Trials Department will provide direct administrative support to the Administrative Director of the CCTO. The ideal candidate must be professional, organized and possess a strong attention to detail. Expertise in Microsoft Office applications is a must, with an emphasis on Outlook, Word and Excel. Must possess the ability to work independently, as well as in a group, and be a self-starter with minimal instruction and oversight.
**Duties of an Administrative Support Assistant may include the following but are not limited to:**
+ Update website with current contact information for office
+ Answer Central Cancer Clinical Trials Office phone and triage calls as necessary
+ Provides assistance to the study team members and potential PIs to answer pre-selection feasibility questionnaires
+ Assists the study team members and study sponsors to schedule site selection visits, site initiation visits, and help with the site initiation process
+ Collaborate with Stony Brook data security, Stony Brook IT and study sponsors to grant necessary access for clinical study monitors
+ Order supplies as needed for office
+ Manage maintenance and services for all shared office equipment
+ Maintain office fixed asset assignment list
+ Assist with scheduling research patient appointments
+ Provide administrative assistance for the CTO Leadership including, but not limited to, calendar management, meeting scheduling, form preparation, etc.
+ Additional administrative assignments may be assigned
**Qualifications**
**Required Qualifications:** Associate's degree. At least 2 years of administrative experience. Proficiency with computer programs including Outlook, Word and Excel.
**Preferred Qualifications:** Administrative experience in a healthcare, clinical, and/or research environment. Experience in oncology and/or clinical trials. Experience with Wolfmart or other procurement systems.
**Special Notes** **:** **Resume/CV should be included with the online application.**
**Posting Overview** **:** This position will remain posted until filled or for a maximum of 90 days. An initial review of all applicants will occur two weeks from the posting date. Candidates are advised on the application that for full consideration, applications must be received before the initial review date (which is within two weeks of the posting date).
If within the initial review no candidate was selected to fill the position posted, additional applications will be considered for the posted position; however, the posting will close once a finalist is identified, and at minimal, two weeks after the initial posting date. Please note, that if no candidate were identified and hired within 90 days from initial posting, the posting would close for review, and possibly reposted at a later date.
______________________________________________________________________________________________________________________________________
+ Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.
+ All Hospital positions maybe subject to changes in pass days and shifts as necessary.
+ This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
+ This function/position maybe designated as "essential." This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities.
**Prior to start date, the selected candidate must meet the following requirements:**
+ Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services
* + Complete electronic reference check with a minimum of three (3) professional references.
+ Successfully complete a 4 panel drug screen
* + Meet Regulatory Requirements for pre employment screenings.
+ Provide a copy of any required New York State license(s)/certificate(s).
**Failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.**
***The hiring department will be responsible for any fee incurred for examination** .
_____________________________________________________________________________________________________________________________________­­
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
**If you need a disability-related accommodation, please call the University Office of Equity and Access at ( .**
**_In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed_** **_here_** **_._**
**Visit our** **WHY WORK HERE** **page to learn about the total reward** **s we offer.**
Stony Brook University Hospital, consistent with our shared core values and our intent to achieve excellence, remains dedicated to supporting healthier and more resilient communities, both locally and globally.
**Anticipated Pay Range:**
The salary range (or hiring range) for this position is $48,839 - $9,533 / year.
The above salary range represents SBUH's good faith and reasonable estimate of the range of possible compensation at the time of posting. The specific salary offer will be based on the candidate's validated years of comparable experience. Any efforts to inflate or misrepresent experience are grounds for disqualification from the application process or termination of employment if hired.
Some positions offer annual supplemental pay such as:
+ Location pay for UUP full-time positions ( 3400)
Your total compensation goes beyond the number in your paycheck. SBUH provides generous leave, health plans, and a state pension that add to your bottom line.
**Job Number:** 2502201
**Official Job Title:** : TH Staff Assistant II
**Job Field** : Other
**Primary Location** : US-NY-Stony Brook
**Department/Hiring Area:** : Clinical Trials
**Schedule** : Full-time
**Shift** : Day Shift **Shift Hours:** : 9:00 AM - 5:00 PM **Pass Days:** : Sat, Sun
**Posting Start Date** : Jun 5, 2025
**Posting End Date** : Sep 3, 2025, 10:59:00 PM
**Salary:** : 52,239 - 62,933 / Total
**Salary Grade:** : SL1
**SBU Area:** : Stony Brook University Hospital
**Req ID:** 2502201
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Clinical Research Associate I

11794 Stony Brook, New York Stony Brook University

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Clinical Research Associate I
**Required Qualifications (as evidenced by an attached resume):**
Bachelor's Degree (foreign equivalent or higher). Two (2) years of full-time clinical research experience. Experience working with study participants. Experience with data analysis, data collection and electronic database entry.
**Preferred Qualifications:**
Certifications for clinical research (i.e Certified Human Research Biomedical Course, research HIPPA training). Experience with hospital electronic medical record review (i.e Cerner Powerchart). Experience working with an IRB (Investigational Review Board) for research protocol submissions, amendments and reviews. Experience with research informed consent process for subject enrollment into trials. Experience in Microsoft Office.
**Brief Description of Duties:**
Be responsible for management of clinical trials conducted at Stony Brook University, Neurosurgical Department. Will conduct screening and recruitment of Neurosurgical patients, obtain study informed consent, data collection, and quality assurance. Will assist with study-related administrative tasks, such as preparing IRB submissions, interim progress reports, updating study databases and study-related correspondence. Will work closely with the sponsors and site physicians for study management. Demonstrates basic computer proficiency. Meets clinical competency requirements. Develops and maintains open dialogue with patient and key personnel to communicate schedule and protocol changes to assure compliance to research project.
**Duties:**
+ Recruit, screen, consent and assist with schedule of research patients for Neurosurgery clinical research trials; collect and submit clinical trial patient data, coordinate patient appointments.
+ Maintain collected data in an electronic database.
+ Maintain study protocol documents and IRB compliance.
+ Perform various administrative duties; maintenance of clinical research study supplies and drug/device accountability.
+ Educate families as well as clinical staff on the research protocol and investigative study drugs/devices.
+ Coordinate patient appointments and assessments as per study protocols.
+ Demonstrate proficiency with hospital EMR, basic computer skills.
+ Coordinate various research trials and ensure compliance with federal guidelines.
+ Interact and correspond with various internal and external constituents including sponsors, cooperative groups, Institutional Review Board and regulatory agencies.
+ May assist the principal investigator with grant submissions and renewals.
+ Attend conferences and research meetings.
+ Assure timely communication of regulatory documents to the IRB. Report Serious Adverse Events as they occur and assists with the completion of FDA and Sponsor forms in accordance with GCP timelines. Oversee research equipment and study supplies.
+ Maintains knowledge and assure adherence to the Code of Federal regulations related to clinical research.
+ Maintain current certification in Human Subjects Research as required **.**
+ Facilitate the preparation of conference abstracts, oral presentations, and poster presentations, and participate in the development of manuscripts for publication **.**
+ Partner with departmental IT resources in the development of databases; data coding manuals and data entry guidelines **.**
+ Ensure that adverse events and protocol deviations are submitted to the IRB **.**
+ May provide research support for clinical trial patient enrollment for acute trials after business hours, on occasion as needed.
+ Other duties as assigned.
**Special Notes:**
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.
This is an in-office position.
For this position, we are unable to sponsor candidates for work visas.
Resume/CV and cover letter should be included with the online application.
**_Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws._**
If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at ( or visit OEA ( .
_In accordance with the Title II Crime Awareness and Security Act_ a _copy of our crime statistics can be viewed_ here ( _._
Visit our WHY WORK HERE ( page to learn about the **total rewards** we offer.
SUNY Research Foundation: A Great Place to Work. ( starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.**
**Job Number:** 2500123
**Official Job Title:** : Clinical Research Associate I
**Job Field** : Research Professional / Technical
**Primary Location** : US-NY-Stony Brook
**Department/Hiring Area:** : Neurosurgery
**Schedule** : Full-time
**Shift** : Day Shift **Shift Hours:** : 9AM-5:30PM :
**Posting Start Date** : Aug 2, 2025
**Posting End Date** : Sep 1, 2025, 8:59:00 AM
**Salary:** : $60,000-$65,000
**Appointment Type:** : Regular
**Salary Grade:** : E99
**SBU Area:** : The Research Foundation for The State University of New York at Stony Brook
**Req ID:** 2500123
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Clinical Research and Data Manager

11794 Stony Brook, New York Stony Brook University

Posted 1 day ago

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Clinical Research and Data Manager
**Required Qualifications (as evidenced by an attached resume):**
Bachelor's degree (foreign equivalent or higher) in Psychology, Neuroscience, Data Science, Biostatistics, Statistics, Mathematics, or a related field. Familiarity with data-driven statistical analyses (such as multivariate covariance-based analyses). Proficiency in STATA, SPSS, Python, R or similar programming/statistical languages. Experience with clinical research databases, including REDCap. Experience with aging research, neurodegenerative diseases (such as Alzheimer's, Parkinson's and/or Dementia) or neuroscience (strong interest supported by student work/research projects may be considered).
**Preferred Qualifications:**
Master's degree (foreign equivalent or higher) in Psychology, Neuroscience, Data Science, or a related field. Experience with setting up and managing complex clinical research databases, including REDCap databases. Knowledge of aging-related biomarkers and clinical and neuroimaging aging research and methodologies. Experience with the acquisition of social, cognitive, and physical data - including social network, quantitative gait, and neuropsychological assessments. Experience training and managing clinical research staff. Experience with neuroimaging data processing tools, including FSL, SPM, and FreeSurfer. Familiarity with high-performance computing (e.g. Penguin) and cloud computing tools (e.g., AWS).
**Brief Description of Duties:**
We are seeking a highly motivated and skilled Clinical Research and Data Manager to join the Social, Cognitive, and Physical Functions in Aging Lab (aka Blumen Aging Lab) in the Department of Neurology. This role is focused on managing clinical research studies that advance our understanding of aging and neurodegenerative diseases - and the data collected in these studies (i.e., social, cognitive, physical and brain/neuroimaging data). The successful candidate will be responsible for supervising data collection and managing complex data sets. The successful candidate will also work with and learn from other members of the Blumen Aging Lab (and the Division of Cognitive and Sensorimotor Aging) to implement data processing and analytic techniques to uncover patterns, trends, and relationships in aging and neurodegenerative disease. The successful candidate will have strong problem-solving skills, attention to detail, and the ability to work independently and as part of a team.
? Supervise and manage data collection and staff in clinical research studies of aging and neurodegenerative disease.
? Assist with the preparation of documents related to research compliance (e.g. IRB, DSMB) and internal/external grant applications.
? Coordinate lab meetings, symposia, workgroups, and conferences.
? Set up, clean, and manage databases with complex data sets.
? Work with and learn from researchers, clinicians, and experts in aging and neurodegenerative diseases to design and implement data processing pipelines and analytic techniques (both data-driven and hypothesis-based approaches.
? Present findings in meetings and contribute to scientific publications and conference presentations.
? Other duties as assigned.
**Special Notes:**
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.
For this position, we are unable to sponsor candidates for work visas.
Resume/CV and cover letter should be included with the online application.
**_Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws._**
If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at ( or visit OEA ( .
_In accordance with the Title II Crime Awareness and Security Act_ a _copy of our crime statistics can be viewed_ here _._
Visit ourWHY WORK HERE page to learn about the **total rewards** we offer.
SUNY Research Foundation: A Great Place to Work. ( starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.
**#LI-JP1**
**Job Number:** 2502985
**Official Job Title:** : Data Manager/Statistician
**Job Field** : Administrative & Professional (non-Clinical)
**Primary Location** : US-NY-Stony Brook
**Department/Hiring Area:** : Neurology
**Schedule** : Full-time
**Shift** : Day Shift **Shift Hours:** : 7.5 :
**Posting Start Date** : Aug 5, 2025
**Posting End Date** : Sep 4, 2025, 11:59:00 PM
**Salary:** : $72,000 - $85,000
**Appointment Type:** : Regular
**Salary Grade:** : E79
**SBU Area:** : The Research Foundation for The State University of New York at Stony Brook
**Req ID:** 2502985
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Senior Clinical Research Program Manager

11590 Westbury, New York Northwell Health

Posted 5 days ago

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**Req Number** 142412
Job Description
Provides management of research administration at a clinical site(s) including monitoring the quality and accuracy of clinical trial data. Follows the established monitoring Standard Operating Procedures (SOP) and protocol- specific monitoring plan. Participates in site initiations and trainings.
Job Responsibility
1.Trains, coaches, supports and mentors Site Clinical Research Managers and other team members.
2.Manages the clinical research sites including, but not limited to acting as primary contact for clinical research sites for questions related to the protocol conduct protocol, regulatory document completion, study supplies, client scheduling, and electronic data capture.
3.Provides on-site or remote monitoring of clinical research site activities to ensure compliance with protocols, SOPs and relevant federal and state regulatory and institutional policies.
4.Provides consultation during study start-up activities regarding development of study protocol, SOP or Case Report Forms (CRFs), site qualification, data collection and study conduct.
5.Patricipates in site initiations and trainings.
6.Assesses accuracy, completeness and timeliness of study records by performing source data verification, regulatory document and consent form review, adverse event reporting compliance review, and investigational product accountability.
7.Performs study close-out monitoring activities.
8.Provides pre-review assistance prior to regulatory inspections and submissions.
9.Provides guidance on regulatory submissions to the FDA which may include an Investigational New Drug (IND), Investigational Device Exemption (IDE), New Drug Application (NDA) or other research under the purview of the FDA.
10.Prepares and forwarding monitoring reports to program manager. Working with study staff to address any concerns.
11.Promotes overall compliance and quality with research conduct through participation in education and training activities for professional staff.
12.Assists in developing appropriate education and training sessions for investigators and clinicians involved in research.
13.Works on assignments that involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors.
14.Regularly makes new recommendations on new processes, tools, and services that can impact multiple projects and other functions.
15.May provide technical guidance and direction to support team members, contractors and/or other vendors.
16.May serve as project/technical lead for ongoing processes or short-term projects within function or family.
17.Performs related duties, as required.
Job Qualification
1.Bachelor's Degree or equivalent combination of education/related experience, required.
3.3-5 years relevant experience, required.
***Additional Salary Detail**
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).
The salary range for this position is $66,220-$108,180/year
It is Northwell Health's policy to provide equal employment opportunity and treat all applicants and employees equally regardless of their age, race, creed/religion, color, national origin, immigration status or citizenship status, sexual orientation, military or veteran status, sex/gender, gender identity, gender expression, disability, pregnancy, genetic information or genetic predisposition or carrier status, marital or familial status, partnership status, victim of domestic violence, sexual or other reproductive health decisions, or other characteristics protected by applicable law.
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Senior Clinical Research Program Manager

11590 Westbury, New York Northwell Health

Posted 5 days ago

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**Req Number** 142953
Job Description
Provides management of research administration at a clinical site(s) including monitoring the quality and accuracy of clinical trial data. Follows the established monitoring Standard Operating Procedures (SOP) and protocol- specific monitoring plan. Participates in site initiations and trainings.
Job Responsibility
1.Trains, coaches, supports and mentors Site Clinical Research Managers and other team members.
2.Manages the clinical research sites including, but not limited to acting as primary contact for clinical research sites for questions related to the protocol conduct protocol, regulatory document completion, study supplies, client scheduling, and electronic data capture.
3.Provides on-site or remote monitoring of clinical research site activities to ensure compliance with protocols, SOPs and relevant federal and state regulatory and institutional policies.
4.Provides consultation during study start-up activities regarding development of study protocol, SOP or Case Report Forms (CRFs), site qualification, data collection and study conduct.
5.Patricipates in site initiations and trainings.
6.Assesses accuracy, completeness and timeliness of study records by performing source data verification, regulatory document and consent form review, adverse event reporting compliance review, and investigational product accountability.
7.Performs study close-out monitoring activities.
8.Provides pre-review assistance prior to regulatory inspections and submissions.
9.Provides guidance on regulatory submissions to the FDA which may include an Investigational New Drug (IND), Investigational Device Exemption (IDE), New Drug Application (NDA) or other research under the purview of the FDA.
10.Prepares and forwarding monitoring reports to program manager. Working with study staff to address any concerns.
11.Promotes overall compliance and quality with research conduct through participation in education and training activities for professional staff.
12.Assists in developing appropriate education and training sessions for investigators and clinicians involved in research.
13.Works on assignments that involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors.
14.Regularly makes new recommendations on new processes, tools, and services that can impact multiple projects and other functions.
15.May provide technical guidance and direction to support team members, contractors and/or other vendors.
16.May serve as project/technical lead for ongoing processes or short-term projects within function or family.
17.Performs related duties, as required.
Job Qualification
1.Bachelor's Degree or equivalent combination of education/related experience, required.
3.3-5 years relevant experience, required.
***Additional Salary Detail**
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).
The salary range for this position is $66,220-$108,180/year
It is Northwell Health's policy to provide equal employment opportunity and treat all applicants and employees equally regardless of their age, race, creed/religion, color, national origin, immigration status or citizenship status, sexual orientation, military or veteran status, sex/gender, gender identity, gender expression, disability, pregnancy, genetic information or genetic predisposition or carrier status, marital or familial status, partnership status, victim of domestic violence, sexual or other reproductive health decisions, or other characteristics protected by applicable law.
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Director of Clinical Research Compliance and Privacy

11790 Stony Brook, New York Stony Brook Medicine

Posted 4 days ago

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Position SummaryThe Stony Brook Medicine (SBM) Director of Clinical Research Compliance and Privacy (DCRCP) will work with hospital leadership, faculty, and related operations teams to ensure current and ongoing management of and education regarding compliance programs that align operational practices with applicable policies and regulations. In this role, the DCRCP will collaborate with Stony Brook University Hospitals, The Renaissance School of Medicine and Stony Brook University leadership to ensure hospital research activities adhere to ethical and legal standards, policies and regulations. The DCRCP will also be required to lead work groups, present to leadership and oversee applicable education and training. The DCRCP will serve on the Executive Governance Compliance Committee and the Compliance and Audit Committee of the Governing Body. Duties of a Director of Clinical Research Compliance and Privacy may include the following but are not limited to: The Director of Clinical Research Compliance and Privacy (DCRCP) is responsible for collaborating with the Office of Research Compliance, Office of the Vice President of Research, Vice Dean for Research, executive leadership department heads, programs directors and other research and academic leaders and teams to assure the development, implementation and ongoing improvement and assessment of the effectiveness of the seven elements of an effective compliance program for the research and academics mission areas. This role involves creating and implementing processes to assess, identify, manage and mitigate research compliance, billing and privacy risks; identify process gaps or control weakness; reduce the potential adverse effects of non-compliance; and develop/assure that effective corrective actions are implemented, as appropriate. The DCRCP serves as a resource, providing guidance to SBM leadership and staff on requirements and regulatory topics pertaining to research and academic compliance. The DCRCP develops, initiates, maintains, and revises the annual compliance and privacy work plan, as applicable for hospital research administration and operations and its related activities to prevent, detect, identify and mitigate illegal, unethical or improper conduct. The DCRCP acts as the primary point of contact for review of agreements that involve any transfers of protected data related to a research activity including the review Institutional Review Board submissions as needed and lead the Data Use Agreement Review Committee. The DCRCP further reviews certain non-disclosure agreements, complex sponsored research contracts, handle negotiation and processing of certain research agreements. The DCRCP conducts internal investigations of suspected privacy or research related billing compliance violations and recommend corrective actions and further, directs identified compliance issues to the appropriate existing channels for evaluation and resolution; and consults with the Office of Research Compliance and applicable departments to improve the compliance of processes; coordinates and prepares reports and assessments as appropriate . The DCRCP is expected to utilize clinical skills to inform role and design and perform detail testing to assess controls in place to address compliance and privacy risks related to clinical research. The DCRCP is expected to manage and develop, as needed, research related privacy and compliance policies and procedures consistent with applicable federal and state laws. The person is this role will develop and deliver applicable privacy and compliance training programs for research and clinical staff, including on topics such as billing and privacy compliance requirements and procedures, research misconduct, protection of human subjects, conflict of interest, effort reporting and responsible conduct of research. The person in this role will work closely with General Counsel's Office, Information Security, the Office of the Chief Research Information Officer, Office of Research Compliance, Stony Brook Medicine Privacy personnel, Office of Sponsored Programs, and Office of Vice President of Research. The DCRCP leads and supervises personnel as assigned; directs communications to teams; builds consensus and drives achievement of SBM research goals, objectives, and initiatives. The DCRCP assists the SBM Chief Compliance Officer as required. Performs other duties as assigned. QualificationsRequired Qualifications: Master's degree in Health Policy, Business, Health Care Administration, Accounting/Finance, Law, Nursing, Health Sciences or a related field. Four (4) years' experience in human subject/clinical research or research compliance, including at least 1-2 years of experience clinical trial monitoring/auditing, research compliance, or regulatory oversight/project management of human subject research protocols. Ability to work collaboratively with clinical, financial, and other departments. Ability to manage multiple initiatives at the same time. In depth knowledge and understanding of fulfilling the elements of an effective compliance program. Strong analytical, communication, and presentation skills are required. Strong interpersonal and verbal communication skills Proficiency in written communication skills Preferred Qualifications: Experience in a higher education environment Certification in Healthcare Research Compliance Special Notes: Resume/CV should be included with the online application. Posting Overview: This position will remain posted until filled or for a maximum of 90 days. An initial review of all applicants will occur two weeks from the posting date. Candidates are advised on the application that for full consideration, applications must be received before the initial review date (which is within two weeks of the posting date).If within the initial review no candidate was selected to fill the position posted, additional applications will be considered for the posted position; however, the posting will close once a finalist is identified, and at minimal, two weeks after the initial posting date. Please note, that if no candidate were identified and hired within 90 days from initial posting, the posting would close for review, and possibly reposted at a later date. Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises. All Hospital positions may be subject to changes in pass days and shifts as necessary. This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair. This function/position may be designated as "essential." This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities. Prior to start date, the selected candidate must meet the following requirements: Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services* Complete electronic reference check with a minimum of three (3) professional references. Successfully complete a 4 panel drug screen* Meet Regulatory Requirements for pre-employment screenings. Provide a copy of any required New York State license(s)/certificate(s). Failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.*The hiring department will be responsible for any fee incurred for examination.Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.If you need a disability-related accommodation, please call the University Office of Equity and Access at ( .In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewedhere.Stony Brook University Hospital, consistent with our shared core values and our intent to achieve excellence, remains dedicated to supporting healthier and more resilient communities, both locally and globally. Anticipated Pay Range: The starting salary range (or hiring range) for this position is - $15000- $193000 / year. The above salary range represents SBUH's good faith and reasonable estimate of the range of possible compensation at the time of posting. The specific salary offer will be based on the candidate's validated years of comparable experience. Any efforts to inflate or misrepresent experience are grounds for disqualification from the application process or termination of employment if hired. Your total compensation goes beyond the number in your paycheck. SBUH provides generous leave, health plans, and state pension that add to your bottom line. Visit ourWHY WORK HERE page to learn about the total rewards we offer.

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Director of Clinical Research Compliance and Privacy

11794 Stony Brook, New York Stony Brook University

Posted 2 days ago

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Job Description

Director of Clinical Research Compliance and Privacy
**Position Summary**
The Stony Brook Medicine (SBM) Director of Clinical Research Compliance and Privacy (DCRCP) will work with hospital leadership, faculty, and related operations teams to ensure current and ongoing management of and education regarding compliance programs that align operational practices with applicable policies and regulations. In this role, the DCRCP will collaborate with Stony Brook University Hospitals, The Renaissance School of Medicine and Stony Brook University leadership to ensure hospital research activities adhere to ethical and legal standards, policies and regulations. The DCRCP will also be required to lead work groups, present to leadership and oversee applicable education and training. The DCRCP will serve on the Executive Governance Compliance Committee and the Compliance and Audit Committee of the Governing Body.
**Duties of a Director of Clinical Research Compliance and Privacy may include the following but are not limited to:**
+ The Director of Clinical Research Compliance and Privacy (DCRCP) is responsible for collaborating with the Office of Research Compliance, Office of the Vice President of Research, Vice Dean for Research, executive leadership department heads, programs directors and other research and academic leaders and teams to assure the development, implementation and ongoing improvement and assessment of the effectiveness of the seven elements of an effective compliance program for the research and academics mission areas.
+ This role involves creating and implementing processes to assess, identify, manage and mitigate research compliance, billing and privacy risks; identify process gaps or control weakness; reduce the potential adverse effects of non-compliance; and develop/assure that effective corrective actions are implemented, as appropriate.
+ The DCRCP serves as a resource, providing guidance to SBM leadership and staff on requirements and regulatory topics pertaining to research and academic compliance.
+ The DCRCP develops, initiates, maintains, and revises the annual compliance and privacy work plan, as applicable for hospital research administration and operations and its related activities to prevent, detect, identify and mitigate illegal, unethical or improper conduct.
+ The DCRCP acts as the primary point of contact for review of agreements that involve any transfers of protected data related to a research activity including the review Institutional Review Board submissions as needed and lead the Data Use Agreement Review Committee. The DCRCP further reviews certain non-disclosure agreements, complex sponsored research contracts, handle negotiation and processing of certain research agreements.
+ The DCRCP conducts internal investigations of suspected privacy or research related billing compliance violations and recommend corrective actions and further, directs identified compliance issues to the appropriate existing channels for evaluation and resolution; and consults with the Office of Research Compliance and applicable departments to improve the compliance of processes; coordinates and prepares reports and assessments as appropriate .
+ The DCRCP is expected to utilize clinical skills to inform role and design and perform detail testing to assess controls in place to address compliance and privacy risks related to clinical research.
+ The DCRCP is expected to manage and develop, as needed, research related privacy and compliance policies and procedures consistent with applicable federal and state laws.
+ The person is this role will develop and deliver applicable privacy and compliance training programs for research and clinical staff, including on topics such as billing and privacy compliance requirements and procedures, research misconduct, protection of human subjects, conflict of interest, effort reporting and responsible conduct of research.
+ The person in this role will work closely with General Counsel's Office, Information Security, the Office of the Chief Research Information Officer, Office of Research Compliance, Stony Brook Medicine Privacy personnel, Office of Sponsored Programs, and Office of Vice President of Research.
+ The DCRCP leads and supervises personnel as assigned; directs communications to teams; builds consensus and drives achievement of SBM research goals, objectives, and initiatives.
+ The DCRCP assists the SBM Chief Compliance Officer as required.
+ Performs other duties as assigned.
**Qualifications**
**Required Qualifications:**
+ Master's degree in Health Policy, Business, Health Care Administration, Accounting/Finance, Law, Nursing, Health Sciences or a related field.
+ Four (4) years' experience in human subject/clinical research or research compliance, including at least 1-2 years of experience clinical trial monitoring/auditing, research compliance, or regulatory oversight/project management of human subject research protocols.
+ Ability to work collaboratively with clinical, financial, and other departments. Ability to manage multiple initiatives at the same time. In depth knowledge and understanding of fulfilling the elements of an effective compliance program. Strong analytical, communication, and presentation skills are required.
+ Strong interpersonal and verbal communication skills
+ Proficiency in written communication skills
**Preferred Qualifications:**
+ Experience in a higher education environment
+ Certification in Healthcare Research Compliance
**Special Notes** **:** **Resume/CV should be included with the online application.**
**Posting Overview** **:** This position will remain posted until filled or for a maximum of 90 days. An initial review of all applicants will occur two weeks from the posting date. Candidates are advised on the application that for full consideration, applications must be received before the initial review date (which is within two weeks of the posting date).
If within the initial review no candidate was selected to fill the position posted, additional applications will be considered for the posted position; however, the posting will close once a finalist is identified, and at minimal, two weeks after the initial posting date. Please note, that if no candidate were identified and hired within 90 days from initial posting, the posting would close for review, and possibly reposted at a later date.
______________________________________________________________________________________________________________________________________
+ Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.
+ All Hospital positions may be subject to changes in pass days and shifts as necessary.
+ This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
+ This function/position may be designated as "essential." This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities.
**Prior to start date, the selected candidate must meet the following requirements:**
+ Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services
* + Complete electronic reference check with a minimum of three (3) professional references.
+ Successfully complete a 4 panel drug screen
* + Meet Regulatory Requirements for pre-employment screenings.
+ Provide a copy of any required New York State license(s)/certificate(s).
**Failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.**
***The hiring department will be responsible for any fee incurred for examination** .
_____________________________________________________________________________________________________________________________________­­
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
**If you need a disability-related accommodation, please call the University Office of Equity and Access at ( .**
**_In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed_** **_here_** **_._**
Stony Brook University Hospital, consistent with our shared core values and our intent to achieve excellence, remains dedicated to supporting healthier and more resilient communities, both locally and globally.
**Anticipated Pay Range:**
The starting salary range (or hiring range) for this position is - $15000- $193000 / year.
The above salary range represents SBUH's good faith and reasonable estimate of the range of possible compensation at the time of posting. The specific salary offer will be based on the candidate's validated years of comparable experience. Any efforts to inflate or misrepresent experience are grounds for disqualification from the application process or termination of employment if hired.
Your total compensation goes beyond the number in your paycheck. SBUH provides generous leave, health plans, and state pension that add to your bottom line.
**Visit our** **WHY WORK HERE** **page to learn about the total rewards we offer.**
**Job Number:** 2502338
**Official Job Title:** : TH Associate Administrator
**Job Field** : Compliance
**Primary Location** : US-NY-Stony Brook
**Department/Hiring Area:** : Compliance
**Schedule** : Full-time
**Shift** : Day Shift **Shift Hours:** : 8:30-5 **Pass Days:** : Sat, Sun
**Posting Start Date** : Jul 10, 2025
**Posting End Date** : Oct 8, 2025, 10:59:00 PM
**Salary:** : 15000 - 193000
**Salary Grade:** : MP3
**SBU Area:** : Stony Brook University Hospital
**Req ID:** 2502338
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