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The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland. This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.

Description of Responsibilities:

• Reports directly to the Program Manager.
• Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies.
• Defines the trial budget and schedule.
• Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately.
• Oversees the screening and qualification of potential study subjects.
• Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly).
• Monitors progress of the trial and reports any issues to the trial director or physician.
• Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly.
• Reviews and updates all Standard Operating Procedures (SOPs) as required.
• Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant.
• Provides and/or coordinates all contractually required reports.
• May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM.
• Other duties as assigned by Supervisor.

Required Degree/Education/Certification:

• Registered Nurse with five (5) years of experience in Clinical Research.
• Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
• Basic Life Support (BLS -CPR/ AED) certification.

Required Skills and Experience:

• Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing).
• Must be able to work independently following a brief period of specific technical training.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of applicable highly complex scientific procedures and techniques relating to position.

Desired Skills and Experience:

• Advanced Cardiac Life Support (ACLS) certification encouraged.

Required Citizenship and Clearance:

• Must be a U.S. Citizen
• Must be able to pass a background check for a NACI.

The Alakaina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! Hybrid work arrangement Medical, Dental, Vision Benefits Health Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug Coverage Telehealth and Behavior Health Services Income Protection – Short Term and Long Term Disability Benefits Retirement Benefits - 401k Company Match on Day One (100% vesting immediately) Group Life Insurance Wellness Programs Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods! Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees. Our Code of Conduct Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us. Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical research and drug discovery organization that was formed in 2007 when SUN Pharmaceutical Industries Ltd separated out its active projects in drug discovery and innovation into a new company to provide the focus and the opportunity for growth of these projects which are now at different stages of preclinical and clinical development. The Clinical Trial Associate will: Customize, coordinate with legal team and other stakeholders for finalization of agreements (e.g. CDA, CSA and vendor agreements). Assist study team in finalization of Feasibility Questionnaire and co-ordinate with site for completion and track collected information. Assist study team in site selection process and document collection. Prepare and compile documents for regulatory submission; as applicable. Coordinate and/or prepare dossiers for EC submission. Coordinate translations of study documents. Coordinate with investigators and sites for IM and assist PM in planning for IM, if applicable. Perform EC submission related activities including co-ordination with study team and other stakeholders. Prepare and dispatch SIV package to sites (including SMF). Prepare, maintain and update in a timely manner, the Trial Master File (TMF/eTMF) and the study folder as per SOP/study requirements. Co-ordinate with vendor(s) for contracted activities. Co-ordinate for procurement, calibration and tracking of Clinical trial supplies including in-house inventory management and ensuring that the sites have all the required supplies at initiation and during the study. Co-ordinate for study/team meetings and prepare minutes. Update and maintain study trackers & study systems (e.g. CTMS) for the assigned projects. Follow up with the study team members/sites/vendors for all the pending documents. Support PM for CRO related activities of outsourced studies. Coordinate with auditors and study team for audits, CAPA preparation and closure as assigned by FH/PM/LM. Initiate and track investigator, site and vendor payments. Co-ordinate for study document archival as applicable. Complete assigned trainings and maintain updated personal training file. Qualifications: Minimum Bachelor’s Degree in a science related field Proficient in Microsoft Office (Word, Excel, and PowerPoint) Excellent written and verbal communication skills #J-18808-Ljbffr

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland . *This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.* DESCRIPTION OF RESPONSIBILITIES: Reports directly to the Program Manager. Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies. Defines the trial budget and schedule. Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately. Oversees the screening and qualification of potential study subjects. Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly). Monitors progress of the trial and reports any issues to the trial director or physician. Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly. Reviews and updates all Standard Operating Procedures (SOPs) as required. Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant. Provides and/or coordinates all contractually required reports. May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM. Other duties as assigned by Supervisor. REQUIRED DEGREE/EDUCATION/CERTIFICATION: Registered Nurse with five (5) years of experience in Clinical Research. Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Basic Life Support (BLS -CPR/ AED) certification. REQUIRED SKILLS AND EXPERIENCE: Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing). Must be able to work independently following a brief period of specific technical training. Ability to establish and maintain effective working relationships with coworkers, managers, and customers. Knowledge of applicable highly complex scientific procedures and techniques relating to position. DESIRED SKILLS AND EXPERIENCE: Advanced Cardiac Life Support (ACLS) certification encouraged. REQUIRED CITIZENSHIP AND CLEARANCE: Must be a U.S. Citizen Must be able to pass a background check for a NACI. The Alaka`na Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays. We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees "EOE, including Disability/Vets" OR "Equal Opportunity Employer, including Disability/Veterans" The Alaka ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke aki Technologies, Laulima Government Solutions, Kpono Government Services, and Kapili Services, Po okela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship. For additional information, please visit #LI-JS1 #ClearanceJobs #J-18808-Ljbffr

The National Institute of Clinical Research, a leading research organization serving the pharmaceutical and biotechnology industries, is seeking a Clinical Trials Regulatory Specialist with 2 or more years of experience, to join our team.

We are looking for a skilled and motivated individual responsible for preparing, reviewing, and maintaining regulatory documents and submissions to ensure full compliance with FDA regulations, ICH-GCP guidelines, and sponsor requirements. This role plays a critical part in supporting clinical trial start-up, maintenance, and close-out activities, ensuring all required documentation is accurate, complete, and submitted in a timely manner.

Responsibilities include:

Prepare and submit regulatory documents (e.g., 1572s, CVs, financial disclosures, protocol submissions, IRB submissions, etc.) for clinical studies.

Track and maintain essential regulatory documents in accordance with sponsor and regulatory requirements.

Communicate with Institutional Review Boards (IRBs), sponsors, and internal departments to ensure regulatory compliance and timely approvals.

Maintain Trial Master File (TMF)/Investigator Site File (ISF) and ensure inspection-readiness.

Monitor study timelines and proactively manage submission deadlines and expirations.

Support study start-up and close-out activities by coordinating required documentation.

Assist with audits and inspections as needed.

Stay current with relevant regulations, guidelines, and industry best practices.

Qualifications:

Bachelor’s degree in Life Sciences, Healthcare, or related field preferred.

Minimum of 2 years of regulatory experience in a clinical research setting.

Knowledge of FDA regulations, ICH-GCP, and clinical research protocols.

Strong organizational skills and attention to detail.

Excellent written and verbal communication skills.

Proficiency with Microsoft Office Suite and electronic regulatory systems.

Preferred Skills:

Experience working with IRBs and regulatory agencies.

Familiarity with CTMS or electronic document management systems.

Clinical Research Coordinator (CRC) or Regulatory Affairs Certification (RAC) is a plus.

Candidates must be local to Orange County, CA area

Location

Garden Grove, CA

Full-time

This is not a remote position

Benefits

Medical Insurance, Dental & Vision Insurance, 401k, PTO

Job Posting Title: Clinical Trials Administrative Associate --- Hiring Department: Dell Medical School --- Position Open To: All Applicants --- Weekly Scheduled Hours: 40 --- FLSA Status: Non-Exempt --- Earliest Start Date: Immediately --- Position Duration: Expected to Continue Until Dec 31, 2025 --- Location: AUSTIN, TX --- Job Details: General Notes The Department of Oncology at the Dell Medical School is looking for a Clinical Trials Administrative Associate. This is a temporary 9 month position, renewable based upon availability of funding, work performance, and progress toward goals. Purpose Assist with administrative tasks in the clinical research department. This position works with the Department of Oncology faculty and staff to facilitate and coordinate administrative, clinical, and financial aspects of multiple research projects. This position requires data entry, file management, document organization, gathering of essential documents, and optimizing feasibility assessments. Responsibilities Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record information into study-specific data-capture systems (both electronic and paper-based). Resolve and answer data queries with minimal errors. Make independent judgments about the relevance of the clinical data to the research for complicated oncology research subjects. Create and maintain patient shadow charts (paper and eCharts ). Enter completed patient visits, protocol deviations and additional data points into Clinical Trials Management System. Collaborate with members of Clinical Research Program team to ensure data entry is up to date and accurately reflects activities relating to research. Request medical records and archival tumor tissue when required from outside medical facilities. Independently develop study-specific or program data acquisition forms. Work professionally with research staff to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions. Principally responsible for maintaining computer spreadsheets and databases for research studies. Understanding research study flow, work with clinic staff support services and research team members. Collate and maintain clinical information from multiple sources into research charts, eCharts , study binders, etc. Help track and maintain research subject schedules based on complex protocol-specific requirements. Departmental newsletter creation and distribution, SOP maintenance, and update logs. Assist Clinical Research team with tracking laboratory sample supplies, completing requisition forms, and assembling kits for upcoming research subject visits for assigned clinical trials. Assist Clinical Research team with tracking and processing research subject samples following study specific guidelines for storage and/or shipping. Other related duties as assigned. Required Qualifications Bachelor's degree in a related field and 1 year of administrative level experience or high school/GED and 5 years of clerical experience. Relevant experience in the medical field. Demonstrated understanding of medical terminology. Strong computer skills, attention to detail and ability to organize work. Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives. Ability to work independently and to carry out complex tasks. Relevant education and experience may be substituted as appropriate. Preferred Qualifications More than two years of relevant experience in the medical field. Experience with data entry and databases. Knowledge of Oncology practice and terminology. Prior experience in billing compliance. Prior experience in basic processing and shipping of laboratory samples. Competency in Microsoft Office software. Knowledge of HIPAA regulations. Knowledge of Good Clinical Practice. Salary Range $32,000+ depending on qualifications Working Conditions May work around standard office conditions. Repetitive use of a keyboard at a workstation. Required Materials Resume/CV 3 work references with their contact information; at least one reference should be from a supervisor Letter of interest Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure thatALLRequired Materials have been uploaded. Once your job application has been submitted, you cannot make changes. Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questionspresented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above. --- Employment Eligibility: Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval. --- Retirement Plan Eligibility: The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length. --- Background Checks: A criminal history background check will be required for finalist(s) under consideration for this position. --- Equal Opportunity Employer: The University of Texas at Austin, as an equal opportunity/affirmative action employer ,complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions. --- Pay Transparency: The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. --- Employment Eligibility Verification: If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university. --- E-Verify: The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university’s company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following: E-Verify Poster (English) (PDF) E-Verify Poster (Spanish) (PDF) Right To Work Poster (English) (PDF) Right To Work Poster (Spanish) (PDF) --- Compliance: Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031 . The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701. #J-18808-Ljbffr

The Department of Oncology at the Dell Medical School is looking for a Clinical Trials Administrative Associate. This is a temporary 9 month position, renewable based upon availability of funding, work performance, and progress toward goals.

Assist with administrative tasks in the clinical research department. This position works with the Department of Oncology faculty and staff to facilitate and coordinate administrative, clinical, and financial aspects of multiple research projects. This position requires data entry, file management, document organization, gathering of essential documents, and optimizing feasibility assessments.

Responsibilities:

• Work independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record information into study-specific data-capture systems (both electronic and paper-based). Resolve and answer data queries with minimal errors. Make independent judgments about the relevance of the clinical data to the research for complicated oncology research subjects. Create and maintain patient shadow charts (paper and eCharts).
• Enter completed patient visits, protocol deviations and additional data points into Clinical Trials Management System. Collaborate with members of Clinical Research Program team to ensure data entry is up to date and accurately reflects activities relating to research. Request medical records and archival tumor tissue when required from outside medical facilities. Independently develop study-specific or program data acquisition forms. Work professionally with research staff to review and correct data recorded in the case report forms. Exercise independent judgment on query resolutions.
• Principally responsible for maintaining computer spreadsheets and databases for research studies. Understanding research study flow, work with clinic staff support services and research team members. Collate and maintain clinical information from multiple sources into research charts, eCharts, study binders, etc. Help track and maintain research subject schedules based on complex protocol-specific requirements.
• Departmental newsletter creation and distribution, SOP maintenance, and update logs.
• Assist Clinical Research team with tracking laboratory sample supplies, completing requisition forms, and assembling kits for upcoming research subject visits for assigned clinical trials. Assist Clinical Research team with tracking and processing research subject samples following study specific guidelines for storage and/or shipping.
• Other related duties as assigned.

Bachelor's degree in a related field and 1 year of administrative level experience or high school/GED and 5 years of clerical experience. Relevant experience in the medical field. Demonstrated understanding of medical terminology. Strong computer skills, attention to detail and ability to organize work. Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues, research subjects, and study sponsor representatives. Ability to work independently and to carry out complex tasks. Relevant education and experience may be substituted as appropriate.

More than two years of relevant experience in the medical field. Experience with data entry and databases. Knowledge of Oncology practice and terminology. Prior experience in billing compliance. Prior experience in basic processing and shipping of laboratory samples. Competency in Microsoft Office software. Knowledge of HIPAA regulations. Knowledge of Good Clinical Practice.

$32,000+ depending on qualifications

• May work around standard office conditions.
• Repetitive use of a keyboard at a workstation.

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest

Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.

Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.

Employment Eligibility: Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.

Retirement Plan Eligibility: The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.

Background Checks: A criminal history background check will be required for finalist(s) under consideration for this position.

Equal Opportunity Employer: The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.

Pay Transparency: The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

Employment Eligibility Verification: If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.

E-Verify: The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university's company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following:

• E-Verify Poster (English) (PDF)
• E-Verify Poster (Spanish) (PDF)
• Right To Work Poster (English) (PDF)
• Right To Work Poster (Spanish) (PDF)

Compliance: Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031. The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.