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The Henry M. Jackson Foundation for the Advancement of Military Medicine · 2 weeks ago

Regulatory Affairs Specialist (Part-Time)- Clinical Trials (SC2i)

Bethesda, MD

Part-time

Hybrid

Mid Level

$30.87/hr - $43.27/hr

3+ years exp

The Henry M. Jackson Foundation for the Advancement of Military Medicine is a nonprofit organization focused on advancing military medicine. They are seeking a Regulatory Compliance Specialist to ensure compliance with regulations for human subjects research and support the Surgical Critical Care Initiative. The role involves reviewing protocols, maintaining regulatory documentation, and collaborating with various stakeholders to facilitate clinical trials.

Health CareMedicalMedical Device

No H1B

Security Clearance Required

U.S. Citizen Only

Responsibilities

Leads the review of protocols, regulatory documentation, and other research activities to ensure compliance with relevant federal and local regulations and policies regarding research involving human subjects, laboratory animals, select agents, the use of multi-omics, and HIPAA

Maintains a regulatory and tracking database, including data entry, queries, and reports

Collaborates with research staff, Principal Investigators, CROs, clinical sites, and Institutional Review Boards to prepare, submit, and obtain approval for new research protocols and relevant agreements

Ensures required protocols are registered and maintained in clinicaltrials.gov

Maintains the department's research protocols and agreements, including all correspondence, and preparing and distributing reports related to the protocols. Works directly with various HJF Headquarter departments on preparation of data sharing/use agreements, material transfer agreements, CRADAs, etc

Provides necessary information for the protocols, such as clearance forms, data forms, rosters, and more. Additionally, prioritizes all administrative tasks to ensure that protocols are expedited in a timely manner

Maintains effective relationships with research staff, Principal Investigators, IRB regulatory personnel, SC2i consortium regulatory counterparts, CROs, and other key stakeholders to ensure continued scientific and operational functioning of assigned protocols

Supports, manages, and coordinates QMS activities related to manufacturing and laboratory compliance

Leads efforts in managing compliance and regulatory issues, and in preparing for research training activities for Principal Investigators and research personnel

Serves as regulatory support for the development of Clinical Decision Support Tools (CDST) and In Vitro Diagnostic (IVD) FDA-regulated clinical trials

Supports various clinical trial activities, including collaboration with regulatory consultants to ensure compliance with regulatory requirements

Prepares and manages all regulatory documentation for FDA submissions, including conducting pathway analyses and preparing Q-Submissions, Pre-IDE, and IDE applications, as well as other necessary documentation to facilitate the FDA approval process

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

Qualification

Regulatory complianceFDA submissionsClinical trialsClinical Research CoordinatorClinical Research AssociateClinical Research ProfessionalMulti-taskingAnalytical skillsCommunication skillsOrganizational skillsInterpersonal skillsProblem-solving skillsTeamworkSelf-starter

Required

Bachelor's Degree is required

Minimum of 3-5 years of experience required

Knowledge of federal and local regulations and policies pertinent to research involving human subject, and recombinant DNA, HIPAA

Excellent communication and writing skills, interpersonal and organizational skills

Must be a self-starter and be able to work independently; must be able to multi-task; ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat Pro, Google Docs, Google Drive and E-mail

Ability to prioritize and manage workload effectively; ability to multi-task effectively; ability to function effectively as part of a team

Ability to identify and research problems/issues thoroughly and use discerning judgment in problem solving for organization, management, and scientific issues using a significant degree of qualitative, quantitative and analytical skill

Outstanding English writing skills

Regulatory experience supporting FDA-regulated clinical trials is necessary. Strong motivation to learn about FDA regulated clinical trial preparation and tracking required

Ability to obtain and maintain a T1 Public Trust Clearance

Ability to stand or sit at a computer for prolonged periods

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.