Regulatory Compliance Coordinator

Location: Bethesda, MD

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.

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 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

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