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Clinical Trial Associate
2 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.
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