Cara Therapeutics, Inc. is searching for an individual to lead and manage its Clinical Trial Master Files (TMF). The candidate will have the opportunity to work with all areas of clinical research studies including but not limited to pain and pruritus. This individual will play a key role in the initiation of clinical trials, collection, and verification of regulatory/clinical documents required to ensure the proper conduct and execution of clinical trials. This individual will also have a key role during TMF FDA audits.
• Work with multiple US and international CROs to set up, collect, verify and archive all documentation required for the completion of TMFs.
• Point of contact for all clinical trial documentation (creation, execution, and archiving of all documents.)
• Serve as a point of contact for internal and external audits of Central File related processes and activities.
• Ensure quality and standardization is established per program and kept up to date as program/protocols progress.
• Support study team to ensure document quality requirements and timelines are met.
• Support study team in addressing queries pertaining to document management.
• Ensure complete Central Files are in place at time of study closure.
• Ensure TMF completeness and accuracy based on Standard Operating Procedures and regulatory requirements.
• Perform periodic regulatory document QC and reconciliation activities, to ensure inspection readiness and regulatory compliance.
• Provide appropriate regulatory documents to Regulatory Affairs team for submission to FDA as needed.
• Create and maintain SOPs and guidelines regarding TMF.
• Provide support to check, complete and transfer previously archived paper TMFs to electronic TMF as applicable.
• Bachelor’s Degree
• Must have Clinical Operations experience with 4+ years of experience filing/archiving paper and electronic TMFs within a pharmaceutical, biotechnology or CRO company.
• Experience with Good Documentation Practice and ICH/GCP compliance, regulatory requirements and FDA/EMA audits a must.
• Strong computer skills and written/verbal communication skills required along with effective organizational skills and attention to detail.
• Hands-on experience with DIA TMF reference model a must.
• Ability to work in a team as well as independently and manage TMF documents across all phases of clinical development from Phase I to Phase IV.