Compass Research is seeking a Compliance Coordinator for its Clinical Research site located in Orlando, Florida.
The Compliance Coordinator is responsible for ensuring data integrity and regulatory requirements and provide support to ensure compliance with FDA regulations, ICH-GCP, and Compass Research SOPs.
- Reviews reported protocol deviations for clarity and completeness.
- Tracks protocol deviations from discovery to documentation completion.
- Performs analysis of deviation trends and communicates findings to Compliance Manager.
- Coordinates scheduling and management of sponsor, IRB and Regulatory audits/inspections.
- Tracks and manages documentation regarding regulatory, sponsor and third party audits.
- Coordinates follow-up of audit findings and communicates with sponsor and/or study team to resolve all outstanding items.
- Tracks monitor letters and follow-up items associated with monitoring reports. Communicates with various members of the study team to complete outstanding items.
- Manages vendor evaluations and documentation of the evaluation process.
- Tracks completion of Corrective and Preventative Action Plans (CAPAs). Communication with sponsor and/or study team to ensure completion of CAPA documentation.
- Ensures that Preventative Action items in CAPAs are implemented by study team and/or sponsor.
- Reviews and tracks completion of Serious Adverse Event Reports. Ensures items are reported to sponsor and/or IRB (if applicable).
- Assists Compliance Manager in creating and implementing new processes and procedures to improve data integrity and quality throughout Compass Research.
- Provides input and support to operations to ensure compliance with SOPs, GCP and other regulatory requirements.
- Performs other duties and responsibilities as assigned.
- Ability to be a champion for data integrity, quality, and regulatory excellence.
- Clear and effective communication skills, both verbal and written.
- Ability to collaborate with other departments to achieve results.
- Excellent organizational skills.
- Strong drive and initiative.
- Bachelor’s degree required.
- At least 2 years clinical research experience