Full-time
Regulatory Affairs Coordinator
Competitive
Bethesda, MDScience & PharmaceuticalPosted 19d ago
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Role overview
Job type
Salary
Competitive
Location
Sector
Posted
19 days ago
Job description
Insider Connection @The Henry M. Jackson Foundation for the Advancement of Military Medicine
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Responsibilities
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 and tracking database to include data entry, queries, and reports
Ensures required protocols are registered and up to date in clinicaltrials.gov
Reviews research personnel training for assigned portfolio to ensure that participating personnel have received appropriate training in human subjects research protection, HIPAA, animal research protection, Good Clinical Practices, conflicts of interest in research, responsible conduct in research, and shipping dangerous goods have been completed
Maintains effective relationship with research staff, Principal Investigators and Institutional Review Boards’ (IRBs) regulatory personnel, and others to ensure continued scientific operational functioning of protocols in assigned portfolio
Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy
Review and process research participant travel and reimbursement and request for clincards
Assists with completion of documents related to regulatory submissions for assigned portfolio and ensures they are submitted prior to their respective deadlines
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
Preferred
At least 1 year of relevant experience preferred
Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred
Benefits
HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.
Hybrid workplace arrangement
Glassdoor
3.6
The Henry M.
Bethesda, Maryland, USA
https://www.hjf.org/
Late Stage
Total Funding
$2.2M
Key Investors
BIRD Foundation
TEDCO
Orthopaedic Research and Education Foundation
2025-10-10
Grant
2024-12-11
Grant· $0.9M
2023-10-24
Grant· $1.3M
Leadership Team
John Lowe
President/CEO
Joseph Caravalho
President and CEO
Recent News
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Qualifications
Bachelor's Degree in a science related field required
Minimum of 0-2 years of experience required
Knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA, HIPAA
Excellent communication and writing skills, interpersonal and organizational skills
Must be a self-starter, be able to work independently, and able to multi-task
Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, and E-mail
US Citizenship and the ability to obtain and maintain a T3/Secret Clearance
At least 1 year of relevant experience preferred
Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred
Minimum of 0-2 years of experience required.
Required skills
Represents the skills you have, click on the tags, Human Subjects Research Regulations, Laboratory Animal Research Regulations, Recombinant DNA Regulations, HIPAA, Adobe Acrobat Pro
Preferred skills
At least 1 year of relevant experience preferred
Experience
Entry level
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