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Clinical Trial Associate
3 months ago
RESPONSIBILITIES
- Support the Clinical Operations team in the execution of clinical trials, initially in the US potentially expanding abroad.
- Supports the management and maintenance of the eTMF for multiple US-based studies.
- Ensure proper access controls are in place for clinical trial documentation.
- Develop and maintain a system for the receipt, tracking, and archiving of clinical trial documentation.
- Provide support in start-up, maintenance, and close-out activities for investigation sites, specifically as these pertain to records management.
- The maintenance and management of assigned sites IRB initial submissions. Ensure all IRB related approvals and correspondence is obtained and archived in the eTMF.
- Provide administrative support.
- Draft meeting agendas and meeting minutes.
- Liaise with facilities/shipping and postal vendors/IT on a routine basis.
- Supports management and maintenance of filing systems for non-TMF documentation.
- Participates in the development and amendment of SOPs as they pertain to trial master file procedures.
- Maintain databases for publication material and investigative sites.
- Perform background research on potential investigators, and in some cases, prospective vendors.
QUALIFICATIONS
- Minimum of Associate’s Degree, Bachelor’s Degree preferred.
- At least 3 years relevant experience functioning as a clinical trial assistant or documentation specialist, or equivalent.
- Previous experience in the Pharmaceutical Industry or Contract Research Organization (CRO).
- Some experience collaborating/interacting with counterparts at CROs and other vendors (laboratories, drug depots, etc.).
- Trial Master File maintenance, auditing, and reconciliation experience.
- Experience and familiarity with TMF maintenance and Essential Documents.
- Experience collaborating and interacting with internal and external partners from a variety of cultural backgrounds and geographic locations. (Although note require, familiarity with other languages will be noted.)
- Experience as the primary responsible party for the management of a Trial Master File (TMF).
- TMF readiness experience.
- Experience with paper and electronic document management systems (eTMF, CTMS, etc.).
- Excel will be used extensively. Experience with chart development and basic functions are necessary.
- Archival of paper files and, if possible, experience auditing archived files.
- Meeting agenda and minute-taking experience.
- Experience tracking study-related equipment.
- Experience/familiarity with any data management electronic data capture systems and/or safety database systems is noteworthy.
- Experience working on international clinical trials.
- Experience interacting with institutional review boards (IRB).
- SOP development experience.
- Experience providing training to new employees and existing employees for new procedures.
- Experience interacting with investigational sites.
- Strong grasp of Good Documentation Practice and International Conference on Harmonisation Good Clinical Practice compliance, specific to the management of Essential Documents.
- An understanding of the regulatory requirements in the United States, as they pertain to essential documents and SOPs.
- Proficient with Windows Office (Word, Excel, and PowerPoint) and Adobe Acrobat.
