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Clinical Research Support Specialist
2 months ago
Position Overview:
We are seeking a dedicated Clinical Trial Assistant to join our team at Advanced Recruiting Partners. This role is essential in supporting the execution of clinical trials within a dynamic biotech environment.
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). Collaborate with Contract Research Organizations (CROs) or partners to address queries and ensure the accuracy and completeness of documentation.
- Assist in the setup of studies within the Clinical Trial Management System (CTMS), providing necessary information to the CTMS team to keep data fields current. Conduct routine quality checks and liaise with partners and CPM to resolve any issues.
- Act as a liaison among partners, CPM, Study Physicians, and Legal teams regarding local Informed Consent queries, ensuring prompt resolutions.
- Review the company’s Data Standard COA Repository and work with the CPM to identify vendors and secure licensing agreements.
- Request the establishment of study-specific mailboxes and manage access accordingly.
- Review aggregate financial reports for studies managed by the CPM, highlighting any significant financial transactions.
- Conduct spot checks on Site Regulatory Packages (SRP), Form FDA 1572s, and Principal Investigator CVs as needed.
- Participate in Clinical Study Team meetings and other trial-related discussions when specific expertise is required.
- Contribute to process improvement initiatives 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 experience in a clinical development environment, particularly with trial startup activities and documentation, is preferred.
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 skills.
- 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.
