Regulatory Compliance Coordinator
$55k - $81k
Mid, Senior
Bachelor's
Bethesda, MD, USA
In Person
Biology & BiotechClinical Research Operations
About the job
Requirements
- A bachelor's degree or equivalent work experience is required.
- Two to four years of clinical research experience is required.
- Experience with Institutional Review Board submissions and/or compliance monitoring is required.
- Competence in oral and written communication is required.
- Must be organized and attentive to detail, with a professional demeanor.
- Must be flexible with changing priorities and able to communicate diplomatically and professionally.
- Must be able to execute the organization's vision in response to changing conditions.
- Must be able to provide leadership, innovative thinking, creative planning, and motivation to staff.
- Must be flexible with changing priorities and available to interact with employees, clients, and sponsors at all levels.
- Must exercise independent judgment in a fast-paced, high-pressure environment with strict deadlines and manage multiple projects.
- Must be able to develop trusting relationships to gain support and achieve results.
- Intermediate-level experience with Excel and other Microsoft Office software is required.
Responsibilities
- Comply with all rules and regulations applicable to the assigned duty station.
- Maintain investigators' curricula vitae, staff license and certification requirements, and other necessary regulatory documents.
- Develop and maintain working relationships with local and regional human protections administrators and Institutional Review Board staff.
- Use knowledge of Food and Drug Administration regulations and International Council for Harmonisation guidelines to ensure compliance during clinical studies and trial conduct.
- Prepare and/or track Institutional Review Board annual reports, protocol amendments and addendums, submissions, protocols, informed consents, statements of work, contracts, and budgets related to the statement of work.
- Prepare and file study binders, notes to study file, and communications logs or files.
- File and maintain study case report forms.
- Maintain and report study subject tracking.
- Promote the safety and confidentiality of research participants.
- Coordinate weekly research meetings, including updates on current and future research, minutes, and reports as needed.
- Prepare interim and final progress reports.
- Provide administrative support to investigators and research staff as needed.
- Monitor research-site progress and activities, and develop and maintain records of research-site activities.
- Prepare and submit quarterly and annual technical reports.
- Ensure publicly released study information is approved by the Public Affairs Office.
- Stay up to date on all relevant research training.
- Maintain and update files of applicable regulatory documentation for Institutional Animal Care and Use Committee or Institutional Review Board matters, including protocols, approvals, amendments, modifications, and communications with sponsors or other federal or regulatory offices, including prior approvals and changes in scope.
- Develop and document policies, best-practice guidelines, and internal controls as needed.
- Direct and supervise the department's technical direction and guidance to ensure compliance with federal, state, and governing regulations and laws.
- Manage award administration and deliverables.
- Oversee the safety and confidentiality of research participants.
- Maintain a collaborative research environment among the principal investigator, other site personnel, research participants, The Geneva Foundation, and the funding organization.
Desired Qualifications
- An advanced degree is preferred.
- One to three years of staff, research, or project management experience is preferred.
- Two to four years of nonprofit, research, or healthcare experience is desired.
- Experience using online Institutional Review Board management systems is preferred.
- Detailed knowledge of regulatory requirements for human-subjects research, including International Council for Harmonisation/Good Clinical Practice guidelines and Food and Drug Administration, Department of Health and Human Services, and Office for Human Research Protections regulations, is preferred.
About the company
The Geneva Foundation advances military medicine to improve the health of service members and the communities they serve through research, development, and education. It leverages 30 years of scientific and program-management expertise to support federal grants, federal contracts, industry-sponsored clinical trials, and educational services. It differentiates itself as a 501(c)(3) nonprofit focused specifically on military health and acts as a bridge among service members, researchers, industry sponsors, and healthcare providers. Its goal is to ensure optimal health for service members and communities by turning medical knowledge into practice.
Company Size
201-500
Company Stage
N/A
Total Funding
N/A
Headquarters
Tacoma, Washington
Founded
1993
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Simplify's Take
What believers are saying
- May 2026 NeuroCatch partnership adds cognitive-health research for warfighter readiness.
- April 2026 DHA award brought $488,276 for breast-cancer research through March 2029.
- June 2026 RESPOND-US membership expands Geneva into trauma and emergency readiness networks.
What critics are saying
- DoD funding concentration makes Geneva hostage to budget shifts and contract renewals.
- Research intermediary model depends on external partners like NeuroCatch and Philips for pipeline.
- A single federal contract collapse could cripple operations and eliminate mission relevance.
What makes The Geneva Foundation unique
- 30+ years advancing military medicine through DoD-aligned research and deployment.
- Master CRADA with Defense Health Agency streamlines research at military treatment facilities.
- Deep portfolio spans AREVA, MIRROR, TSNRP, REC^3^ON, and 4DBio3 programs.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Account/Flexible Spending Account
- Disability Insurance
- Life Insurance
- Paid Vacation
- Paid Holidays
- Professional Development Budget