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Clinical Trial Associate
4 weeks ago
Key Responsibilities:
- Support the Clinical Operations team in executing clinical trials, initially in the US with potential expansion abroad.
- Manage and maintain the electronic Trial Master File (eTMF) for multiple US-based studies.
- Ensure proper access controls for clinical trial documentation.
- Develop and maintain systems for the receipt, tracking, and archiving of clinical trial documents.
- Assist in start-up, maintenance, and close-out activities for investigation sites, focusing on records management.
- Manage IRB initial submissions and ensure all IRB-related approvals and correspondence are archived in the eTMF.
- Provide administrative support, including drafting meeting agendas and minutes.
- Liaise with facilities, shipping vendors, postal services, and IT.
- Manage filing systems for non-TMF documentation.
- Participate in the development and amendment of SOPs related to trial master file procedures.
- Maintain databases for publication materials and investigative sites.
- Conduct background research on potential investigators and prospective vendors.
Qualifications:
- Strong understanding of Good Documentation Practice and ICH GCP compliance, specific to the management of Essential Documents.
- Knowledge of US regulatory requirements related to essential documents and SOPs.
- Proficient in Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat.
- Excellent organizational, verbal, and written communication skills.
- Fluent in English.
- Flexibility to occasionally attend meetings outside traditional work hours due to the international nature of the organization.
- Ability to work independently with minimal supervision.
- Physical ability to lift archiving boxes (up to 25 lbs).
- Strong interpersonal skills for effective collaboration.
Education and Experience:
- Minimum Associate's Degree, Bachelor's Degree preferred.
- At least 3 years of relevant experience as a clinical trial assistant or documentation specialist, or equivalent.
- Experience in the Pharmaceutical Industry or with a Contract Research Organization (CRO).
- Familiarity with TMF maintenance, auditing, and reconciliation.
- Experience managing Trial Master Files (TMF) and readiness for audits.
- Proficiency with electronic document management systems (eTMF, CTMS, etc.).
- Experience with Excel, including chart development and basic functions.
- Experience in archival of paper files and auditing archived files.
- Meeting agenda and minute-taking experience.
- Experience with data management systems and safety databases is a plus.
- Experience working on international clinical trials and interacting with IRBs.
- SOP development experience.
- Training experience for new and existing employees on procedures.
- Calendar management experience.
- Experience interacting with investigational sites.
Travel:
- Minimal travel required.
Work Environment:
This is an office-based position located in Pennington, NJ. The role involves frequent sitting, standing, walking, and computer use. Reasonable accommodations can be made for individuals with disabilities.
My client is a leading biotech research organization dedicated to advancing clinical research and development with a focus on quality and safety. Their parent company has a significant presence in global markets and partnerships with top-tier international pharmaceutical companies, leveraging over 50 years of manufacturing and development expertise. Their mission includes the development of novel therapeutics and new chemical entities.
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