Regulatory Compliance Coordinator

The Regulatory Compliance Coordinator serves as the regulatory subject matter expert to ensure Springfield Clinic's research operations and its employees adhere to local and federal clinical research regulations at all times. The Regulatory Compliance Coordinator provides expert, current, and working knowledge of all Institutional Review Board (IRB) submission requirements and full regulatory compliance aspects for scientific, pharmaceutical, and medical device research.

Job Relationships

• Reports to the Clinical Research Manager

Principal Responsibilities

• Serves as the primary regulatory point of contact for sponsor-funded multi-center clinical trials.
• Provides audit information to sponsors and regulatory officials by researching and analyzing data, preparing reports, performing risk assessments, and enforcing CAPAS as needed.
• Monitors and reconciles compliance deviations via investigation and development of solutions.
• Develops and implements internal auditing policies and procedures to ensure compliance within local and federal regulatory agencies.
• Reviews informed consents prior to submission to ensure institutional standards are met and all required information is included.
• Coordinates regulatory documentation completion, including but not limited to IRB-approval documents, continuing review approvals, FDA 1572's, required trainings and certifications, and other compliance-related documents.
• Ensures complete, accurate, and timely audit information is reported to the administration, clinical trial sponsors, and appropriate regulatory agencies.
• Serves as the primary representative to maintain all institutional clinical research records and documents according to local and federal requirements.
• Coordinates with Principal Investigators and departments accurate completion of all trial revisions and/or amendments within critical timelines.
• Coordinates trial start-up, monitoring, and close-out regulatory activities and ensures the appropriate administration, key players, and regulatory authorities are properly informed.
• Researches, develops, and recommends to the Research Manager updates on laws, regulations, and FDA guidance to ensure institutional policy meets all local and federal regulations.
• Trains staff as needed according to current regulatory policies.
• Comply with the Springfield Clinic incident reporting policy and procedures..
• Provide excellent customer service and adhere to Springfield Clinic's Code of Conduct and Ethics Standards.
• Perform other job duties as assigned.

Education/Experience

• Bachelor's Degree in chemical or biological sciences or an equivalent combination of education and applicable experience in health care research or regulatory environments.
• 3-5 years of experience in clinical research or a related regulatory-stringent field.

Licenses/Certificates

• A current, up-to-date, and maintained research certification (CCRP or CCRC) is highly-preferred.

Knowledge, Skills and Abilities

• Significant and executable experience working with Principal Investigators, clinical research staff, pharmaceutical industry sponsors, the FDA, auditors (monitors), and/or consortiums.
• Strong working knowledge of all current local and federal GCP, ICH, CFR, and HIPAA regulations.
• Exceptional attention to detail and the ability to understand all regulatory aspects of approved clinical research protocols.
• Ability to complete assigned tasks independently, efficiently, and on time; possibly at times of regulatory urgency.
• Professionally-acceptable organizational, oral, and written communication skills as well as excellent interpersonal skills to work efficiently with departmental colleagues, managers, directors, administration, physicians, and third-party sponsors.
• Strong working knowledge of professional office software including but not limited to Windows (current version with networking), Microsoft Office (including Word, Excel, PowerPoint, and Outlook), and Adobe (Reader and DC).
• Inter-professional skills to adjust situations and find solutions with various personalities and situations.
• Strong critical thinking skills and the ability to solve professional problems, possibly at multiple angles of consideration.
• Knowledge and awareness of standard biohazard protocols and pharmaceutical chain-of-custody regulations.

Working Environment

• Standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
• Stand and/or walk for long periods of time with a capacity to stoop, bend, and lift.
• Office based with potential travel to other Springfield Clinic locations as required.

PHI/Privacy Level

• HIPAA2