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Clinical Research Support Specialist
2 months ago
Position Overview:
A Clinical Trial Assistant role is available with Advanced Recruiting Partners, focusing on supporting clinical research activities.
Key Responsibilities:
- Develop and maintain the Trial Master File (TMF) Plan, ensuring ongoing quality control checks for sections managed by the Clinical Project Manager (CPM). Provide feedback to Contract Research Organizations (CROs) or partners to guarantee the accuracy and completeness of documentation.
- Assist in the establishment of studies within the Clinical Trial Management System (CTMS), ensuring that relevant data fields are consistently updated. Conduct regular quality checks on the CTMS and collaborate with partners and CPM to address any discrepancies.
- Act as a liaison among partners, CPM, Study Physicians, and Legal teams regarding local Informed Consent inquiries, ensuring prompt resolutions.
- Review the company’s Data Standard COA Repository and work with the CPM to identify vendors and secure necessary licensing agreements.
- Coordinate the creation of study-specific mailboxes and manage access rights effectively.
- Analyze aggregate financial reports for studies overseen by the CPM, highlighting any notable financial transactions.
- Conduct spot checks on Site Regulatory Packages (SRP), Form FDA 1572s, and Principal Investigator CVs as required.
- Participate in Clinical Study Team meetings and other trial-related discussions where your expertise is essential.
- Contribute to initiatives aimed at process improvement and share best practices with your Line Manager and/or CPM.
Qualifications:
A Bachelor’s Degree or equivalent experience in a clinical development environment is required.
At least 2 years of relevant experience is preferred, particularly in clinical development, including trial start-up processes and documentation.
Essential Skills:
- Proficient in Microsoft Office Suite.
- Ability to quickly learn new tasks and skills.
- Strong organizational and time management capabilities.
- Preferred background in scientific and technical disciplines.
- Familiarity with Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) Guidelines, as well as FDA and/or EU regulations.
- A positive attitude towards change management.
- Basic understanding of medical terminology.
