Regulatory Compliance Coordinator

The Geneva Foundation•Bethesda, MD

4d•$55,000 - $81,000

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.

Requirements

Bachelor’s degree or equivalent work experience required
2-4 years’ experience in clinical research experience required
IRB submission and/or compliance monitoring experience required
Demonstrate competence in oral and written communication
Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor
Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
Ability to execute the vision of the organization in response to changing conditions
Ability to provide strong leadership, innovative thinking, creative planning, and effective motivation 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 with strict 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 other Microsoft Office Software

Nice To Haves

advanced degree preferred
1-3 years’ experience in staff, research or project management preferred
2-4 years non-profit, research, or healthcare experience desired
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

Responsibilities

Comply with all rules and regulations as applicable to assigned duty station
Maintains all investigator Curriculum Vitaes, all staff license and certification requirements and all other regulatory document as necessary
Develops and maintains working relationships with local and regional human protections administrators (HPA) and IRB staff.
Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance during clinical studies and trial conduct.
Prepare and/or tracks Institutional Review Board (IRB) annual reports, protocol amendments 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 future research, 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 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 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 any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.)
Develop and document, as needed, policies and best practice guidelines and internal controls
Direct and supervise the technical direction and guidance to the department to ensure compliance 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 site personnel, research participants, The Geneva Foundation and the funding organization