Clinical Trial Associate

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.