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Clinical Research Compliance Coordinator
2 months ago
Salary:
Articularis Healthcare Group (AHG) is actively looking for a full-time Clinical Research Regulatory Coordinator.
About Us:
Articularis Healthcare Group, Inc (AHG) is a physician-led organization committed to enhancing healthcare by supporting independent rheumatology practices nationwide. As the largest rheumatology specialty group in the country, with over 20 practices across 7 states, we provide access to optimal business practices, advisory and management services, and value-based treatment pathways.
Our Mission:
To deliver the highest quality community-based rheumatology services with a focus on patient care, physician leadership, and excellence.
Position Summary:
The Clinical Research Regulatory Coordinator will oversee regulatory support for the research program and ensure the maintenance of all necessary regulatory documents. This role will be fully accountable for transitioning and maintaining paper to electronic regulatory files for all ongoing studies and will utilize the designated Clinical Trial Management System (CTMS) for future studies. Effective communication and collaboration with internal and external team members are essential to ensure that research regulatory documentation is complete and compliant with state and federal regulations as well as Sponsor requirements.
Key Responsibilities:
- Facilitating study initiation by preparing all required documents for initial submission to the Institutional Review Board (IRB) and Sponsors, including but not limited to Investigational Drug Brochure (IDB), informed consent forms (ICF), safety letters, Form FDA 1572, CVs, protocols, protocol signature pages, memos, amendments, advertisements, and educational materials.
- Monitoring and preparing documents for annual IRB review; ensuring that approval letters are sent to and received from Sponsors.
- Executing study close-out regulatory activities in accordance with local and Sponsor policies, as well as regulatory agency guidelines.
- Maintaining and updating Delegation of Authority (DOA) logs.
- Communicating with study Sponsors and other regulatory personnel as necessary to keep regulatory files current and ready for inspections/audits.
- Conducting internal regulatory audits to ensure adherence to all state, federal, and local regulations.
- Developing and implementing a work plan for transitioning all active studies from paper-based to electronic records, ensuring continuity of both electronic and paper-based records.
- Taking ownership of AHG research archiving, ensuring all documents are accounted for, protected, and secure upon study closure.
- Receiving monitor and audit letters, ensuring that all outstanding or pending items are addressed promptly.
- Collaborating with the Research Manager and Coordinators to schedule and assist with monitor, auditor, and/or regulatory agency visits.
- Mentoring new research staff as appropriate.
- Assisting in the development of standard regulatory-related training requirements and ongoing regulatory education for investigators and research personnel.
- Maintaining professional and technical knowledge through self-directed learning.
- Working independently and with the research team to resolve compliance issues in a timely manner.
- Performing additional duties as assigned.
This position may be a fit for you if:
- You possess a Bachelor's degree in Clinical Laboratory Science, Medical Laboratory Technician, Chemical Science, or have equivalent work experience.
- You hold a current MLS or MT certification (ASCP or AMT).
- You have at least 2 years of clinical lab experience.
- You demonstrate strong verbal and written communication skills.
- You are capable of managing multiple tasks effectively.
Benefits of Joining AHG:
Being part of our team offers a positive work environment, opportunities for growth and advancement, and a healthy work/life balance. With office hours from Monday to Thursday, you can enjoy your evenings and 3-day weekends with family and friends.
Next Steps:
Upon submitting your application, a member of our Talent Acquisition Team will review your resume and application. A team member will reach out to you within a week to schedule a phone screening.
EEO/AA-M/F/disabled/protected veteran
*Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
