Clinical Research Coordinator
2 weeks 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, performing ongoing and final quality control checks for sections managed by the Clinical Project Manager (CPM). Provide feedback to Contract Research Organizations (CROs) or partners to ensure the accuracy and completeness of documentation.
- Assist in the setup of studies within the Clinical Trial Management System (CTMS), ensuring that data fields are updated accurately. Conduct regular quality checks of the CTMS and collaborate with partners and CPM to resolve any issues.
- Act as a liaison among partners, CPM, Study Physicians, and Legal teams regarding local Informed Consent inquiries, ensuring prompt resolution.
- 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 appropriately.
- 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 improvement 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 environment is required, along with a minimum of 2 years of relevant experience, particularly in 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 Conference on Harmonisation (ICH) Guidelines, as well as FDA and/or EU regulations.
- A positive attitude towards change management.
- Basic understanding of medical terminology.
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