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Geneva Foundation

60 Geneva Foundation Program Manager Jobs Hiring Near You

The Geneva Foundation

$75K - $85K/yr

At Geneva, we are always on the search for top talent. While this role is not associated with a ... PhD or MD required * 1-2 years medical research project management experience strongly desired ...

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Infographic showing various Program Manager job openings at Geneva Foundation in the United States as of August 2026, with employment types broken down into 96% Full Time, and 4% Part Time. Highlights an 71% Physical, 27% Hybrid, and 2% Remote job distribution.

Regulatory Compliance Coordinator

The Geneva Foundation

Bethesda, MD

$55K - $81K/yr

Full-time

Posted 10 days ago

Job description

About the Position
The Regulatory Compliance Coordinator prepares, submits and maintains regulatory documents related to research; serves as principal administration liaison for projects; develops and maintains recordkeeping systems and procedures; prepares documents including interim and final progress reports which support research projects.
About the Project
Support cutting-edge research to investigate non-invasive ways to measure and modulate sleep in US Warfighters. Learn more about our Lab here:
https://www.swordusuhs.org/
Salary Range
$55,000 - $81,000. Salaries are determined based on several factors including external market data, internal equity, and the candidate's related knowledge, skills, and abilities for the position.

Qualifications

  • Bachelor's degree or equivalent work experience required, advanced degree preferred
  • 2-4 years' experience in clinical research experience required
  • 1-3 years' experience in staff, research or project management preferred
  • 2-4 years non-profit, research, or healthcare experience desired
  • IRB submission and/or compliance monitoring experience required
  • Experience using online IRB management systems preferred
  • Detailed knowledge of regulatory requirements for conducting human subjects research,including ICH/GCP guidelines, FDA, DHHS, and OHRP regulations preferred
  • Demonstrate competence in oral and written communication
  • Must be organized, attentive to detail, and possess a positive, friendly and professionaldemeanor
  • Must be flexible with changing priorities and able to communicate in a diplomatic andprofessional manner
  • Ability to execute the vision of the organization in response to changing conditions
  • Ability to provide strong leadership, innovative thinking, creative planning, and effectivemotivation skills to staff
  • Ability to be flexible with changing priorities and available to interact with employees,clients and sponsors of all levels
  • Ability to exercise independent judgment in fast-paced, high-pressured environment withstrict deadlines and to manage multiple projects
  • Ability to develop strong trusting relationships in order to gain support and achieve results
  • Computer skills including at least intermediate level experience with Excel and otherMicrosoft Office Software


Responsibilities

  • Comply with all rules and regulations as applicable to assigned duty station
  • Maintains all investigator Curriculum Vitaes, all staff license and certification requirementsand all other regulatory document as necessary
  • Develops and maintains working relationships with local and regional human protectionsadministrators (HPA) and IRB staff.
  • Uses thorough knowledge of FDA regulations and ICH guidelines to ensure complianceduring clinical studies and trial conduct.
  • Prepare and/or tracks Institutional Review Board (IRB) annual reports, protocolamendments and addendums, IRB submissions, protocols, informed consents,statements of work, contracts and budgets as related to the statement of work
  • Prepare and files study binder, "notes to study file" and communications log/file
  • File and maintain study case report forms
  • Maintain and reports study subject tracking
  • Promote safety and confidentiality of research participants at all times
  • Act as coordinator for weekly research meeting, including updates of current and futureresearch, minutes and reports as needed
  • Prepare interim and final progress reports
  • Provide administrative support to investigators and research staff as needed
  • Monitor progress of research sites and activities; develop and maintain records ofresearch 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 in all relevant research training
  • Maintain and update files of all applicable regulatory documentation for IACUC or IRB(including protocols, approvals, amendments, modifications, etc.) as well as anycommunications with the sponsor or any other Federal or regulatory office (including priorapprovals, change in scope, etc.)
  • Develop and document, as needed, policies and best practice guidelines and internalcontrols
  • Direct and supervise the technical direction and guidance to the department to ensurecompliance with all federal, state and governing regulations/laws
  • Manage award administration and deliverables
  • Oversee safety and confidentiality of research participants at all times
  • Maintain collaborative research environment between the principal investigator, other sitepersonnel, research participants, The Geneva Foundation and the funding organization

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