Clinical Study Associate
1 week ago
Compass Consulting is seeking a highly organized and detail-oriented Clinical Study Associate to support our Clinical Services Management team. As a Clinical Study Associate, you will play a critical role in ensuring the successful execution of clinical studies and audits for our medical diagnostic products.
Key Responsibilities- Study Coordination: Coordinate with cross-functional teams to ensure timely and accurate completion of study-related tasks, including Sponsor Monitoring Visits, Study/site Qualification and Initiation Visits, Monitoring Visits, Closure Visits, and Ad hoc Visits.
- Documentation Management: Maintain and manage study documents, including Delegation of Authority (DOA) Logs, device accountability logs, and good documentation practices (GDP) for laboratory personnel.
- Calendar Management: Coordinate with applicable functions to schedule SIV, Monitoring Visits, Closing Visits, and/or Audits.
- Supplier Questionnaire Management: Complete supplier questionnaires using captured information and ensure follow-up with Subject Matter Experts to complete documents on time.
- Process Improvement: Participate in process improvement initiatives to enhance the efficiency and effectiveness of clinical study operations.
- Education: Bachelor's degree in life sciences, nursing, or a related field of study; Business Administration or similar expertise through experience.
- Experience: 2 years of administrative management, entry-level CRA (clinical research associate), CTA experience, or a history of working with histo-technology laboratories preferred but not required.
- Skills: Strong communication skills, proficient in English language, both written and oral communications; other languages desirable. Proficient in Microsoft Office (Word, Excel, PowerPoint) and Google Tools. Excellent organizational skills and able to multi-task.
- Cancer Research Experience: Experience in cancer research and/or a working knowledge of ICH-GCP guidelines related to clinical trials.
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