Clinical Research Compliance Lead

The Geneva Foundation; Bethesda (MD); On-site; USD 55,000 - 81,000; Full time

Benefits offered by this job

403b retirement plan with employer-mat

Paid time off & holidays

Comprehensive health coverage

Job summary

The Geneva Foundation seeks a Regulatory Compliance Coordinator to prepare, submit, and maintain regulatory documents for clinical research projects. You will liaison with project teams, develop recordkeeping systems, and support investigators with IRB submissions and annual reports.

You will apply knowledge of ICH/GCP, FDA and OHRP requirements, manage documents, and ensure safety and confidentiality of participants. Strong communication and organizational skills are essential.

Qualifications

• Bachelor’s degree or equivalent work experience required, advanced degree preferred.
• 2-4 years’ experience in clinical research 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

Responsibilities

• Comply with all rules and regulations as applicable to assigned duty station
• Maintains all investigator Curricula Vitae, 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

Skills

Regulatory compliance

Clinical research

IRB submission

FDA regulations

ICH/GCP guidelines

Documentation management

Communication skills

Excel

Education

Bachelor's degree or equivalent

Advanced degree preferred

Tools

Excel

IRB management systems

Job description

The Geneva Foundation seeks a Regulatory Compliance Coordinator to prepare, submit, and maintain regulatory documents for clinical research projects. You will liaison with project teams, develop recordkeeping systems, and support investigators with IRB submissions and annual reports.

You will apply knowledge of ICH/GCP, FDA and OHRP requirements, manage documents, and ensure safety and confidentiality of participants. Strong communication and organizational skills are essential.