5 regulatory affairs coordinator Jobs in bethesda, md

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Regulatory Affairs Coordinator

Henry M. Jackson Foundation for the Advancement of Military Medicine

Bethesda, MD | Full Time

$66k-86k (estimate)

0 Months Ago

ASSOCIATE DIRECTOR, REGULATORY AFFAIRS

Technical Resources International, Inc.

Bethesda, MD | Full Time

$180k-238k (estimate)

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Regulatory Affairs Coordinator - Prostate Cancer

Henry M. Jackson Foundation for the Advancement of Military Medicine

Bethesda, MD | Full Time

$70k-91k (estimate)

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Director of Regulatory Affairs

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Bethesda, MD | Full Time

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Coordinator, Multicultural Affairs, Social Impact, and Business Councils

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Bethesda, MD | Full Time

$58k-73k (estimate)

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Regulatory Affairs Coordinator

$66k-86k (estimate)

Full Time 0 Months Ago

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Henry M. Jackson Foundation for the Advancement of Military Medicine is Hiring a Regulatory Affairs Coordinator Near Bethesda, MD

Join the HJF Team!

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

HJF is seeking a Regulatory Affairs Coordinator to be responsible for assisting in the compliance of HJF research programs with applicable local, state, federal, and Department of Defense (DoD) regulations for human subjects’ research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA).

Position Overview:

This position will be in support of the Uniformed Services University (USU), Murtha Cancer Center Research Program’s (MCCRP) Center for Prostate Disease Research (CPDR) located at the Rockledge Office in Bethesda, MD.

Please click here to learn more about CPDR.

Note: This site requires that the incumbent has lived in the US for three out of the past five years.

Responsibilities:

Coordinates, tracks, and assists with completion of documents related to regulatory submissions for assigned CPDR projects and ensures they are submitted prior to their respective deadlines.
Maintains electronic records of all research protocols for the program and within the Florence system. This includes human, animal, and basic science research protocols, correspondence, and storage retention policies.
Assists with the review of protocols, grants, contracts, clinical trials, and other research activities to ensure compliance with relevant federal and local regulations and polices of research involving human subjects, laboratory animals, select agents, utilization of recombinant DNA and HIPAA.
Assists with maintaining a regulatory database to include data entry, queries, and reports.
Reviews, tracks, and maintains CVs and research training for the CPDR program to ensure personnel have received appropriate training in all applicable courses.
Maintains effective relationship with research staff, Principal Investigators, and Institutional Review Boards’ (IRBs) regulatory personnel, and others to ensure continued scientific operational functioning of assigned projects.
Monitors publications and website information from federal and DoD regulatory agencies to gain current information concerning changes in regulatory policy.
May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities:

Must have experience working with an Institutional Review Board (IRB).
Must have knowledge of federal and local regulations and policies pertinent to research involving human subjects, laboratory animals, recombinant DNA, and HIPAA.
Excellent detail orientation, communication, writing skills, interpersonal, and organizational skills to effectively express ideas, convey information, foster teamwork, problem-solve, and meet deadlines.
Must be a self-starter, be able to work independently, and able to multi-task.
Willingness to embrace new duties when needed, following appropriate instruction and supervision. Dependable team member and can work well within a dynamic, results-oriented group.
Ability to moderately utilize full computer application packages, such as Microsoft 365 (Outlook, Word, Excel, PowerPoint) and other E-mail systems.
Adobe Acrobat Pro experience preferred.
iMedRis system experience preferred.
Florence experience preferred.
FileMaker Pro experience preferred.
DoD experience preferred.

Physical Capabilities

Lifting: Requires lifting materials up to 10 lbs.
Ability to stand or sit at a computer for prolonged periods.

Qualifications

Work Environment

This position will take place primarily in an office setting.

Education and Experience

Bachelor’s Degree is required.
Minimum of 0-2 years of experience required.

Licenses and Certifications

Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor 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. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Job Summary

JOB TYPE

Full Time

SALARY

$66k-86k (estimate)

POST DATE

05/21/2023

EXPIRATION DATE

05/14/2024

WEBSITE

hjf.org

HEADQUARTERS

Bethesda, MD

SIZE

1,000 - 3,000

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