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Clinical Research Support Specialist
2 months ago
Position Overview:
We are seeking a Clinical Trial Assistant to join our team at Advanced Recruiting Partners. This role is essential in supporting the clinical trial process within a dynamic Biotech environment.
Key Responsibilities:
- Develop and maintain the Trial Master File (TMF) Plan, ensuring thorough ongoing and final quality control checks for sections managed by the Clinical Project Manager (CPM). Provide constructive feedback to Contract Research Organizations (CROs) or partners to guarantee the accuracy and completeness of documentation.
- Assist in the setup of studies within the Clinical Trial Management System (CTMS), ensuring that data fields managed by the company are consistently updated. Conduct regular quality checks of the CTMS and collaborate with partners and CPM to address any issues.
- 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 collaborate with the CPM to identify suitable vendors and secure licensing agreements.
- Coordinate the establishment of study-specific mailboxes and manage access permissions.
- Request and analyze aggregate financial reports for studies overseen by the CPM, highlighting any significant 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 when specialized knowledge is needed.
- Contribute to initiatives aimed at process enhancement and share best practices with the Line Manager and/or CPM as appropriate.
Qualifications:
A Bachelor’s Degree or equivalent experience in a clinical development setting is required. A minimum of 2 years of relevant experience is preferred, particularly in clinical development, including trial startup activities and documentation.
Skills and Competencies:
- Proficient in Microsoft Office Suite.
- Ability to quickly learn new tasks and skills.
- Strong organizational and time management abilities.
- Preferred scientific and technical knowledge.
- Familiarity with Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) Guidelines, as well as FDA and/or EU regulations.
- A positive approach to Change Management.
- Basic understanding of medical terminology.
