Note: The job is a remote job and is open to candidates in USA. Harbor Clinical is seeking Contract Senior Clinical Research Associates to support Medical Device studies across various Therapeutic Areas. The role involves conducting monitoring visits, ensuring protocol compliance, and providing training to clinical site staff.

Responsibilities

• Conduct monitoring visits to include SIVs, IMVs with strong study startup experience
• Medical device experience required
• Work with clinical site staff to obtain study data, ensure protocol compliance and ensure patient safety
• Provide training to site staff as required
• Participate in internal and study site team meetings
• Support the development of internal documents and study manuals as needed
• Perform SDVs
• Timely completion of Visit Reports

Skills

• Medical device experience required
• Minimum 4 years' experience of clinical site monitoring
• Medical Device monitoring experience required
• Experience with Veeva CTMS and eTMF required
• Understanding and knowledge of current industry regulations and guidelines
• Strong organizational/communication skills and attention to detail
• Ability to work independently/exercise critical thinking while also being an active member of the internal team
• Willing to perform other work-related duties as assigned
• Bachelor's Degree, in nursing, life sciences or related field preferred

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