Cra Iii - (US-MA-Raynham - 02768)

Minimum Education: None
Job Type: Full Time
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Responsibilities : Periodic travel to sponsor headquarters for up to 1 week at a time required• Efficiently manage between 6-8 study sites.• Prepare pre- and post-monitoring visit correspondence with good attention detail and high level of quality• Active engagement and collaboration with study sites to ensure compliance with sponsor as well as IRB reporting requirements• Active engagement and collaboration with study sites to resolve queries and open action items in a timely manner• Proactive identification and management of potential quality concerns• Training of new study site personnel on protocol and study requirements• Provide real-time updates to Project Manager and sponsor Project Team.•  may be remote/home-based depending on applicant’s location and needs of the study. Ability to work independently with minimal oversight if remotely based.Monitoring activities to include review of:• device accountability records• regulatory records• subject eCRFs and source documentation• subject enrollment records• engage CRC and PI concerning visit findings and action plans.

Requirements : BA/BS in nursing and/or life or health sciences• A minimum of 5 years experience in clinical research; 3 years as a clinical site monitor• Experience with device trials strongly preferred• Sound working knowledge of the Code of Federal Regulations, Good Clinical Practice and ICH guidelines as applied to drug trials• Ability to establish and maintain effective working relationships with study site personnel other team members• Ability to communicate in a professional but results-driven manner with both site coordinators as well as surgeons• Sound knowledge of medical terminology, particularly spine and related pathologies• Able to review and interpret patient medical records and draw concise conclusions• Strong knowledge working in Microsoft Office Programs and other software packages• Ability to problem-solve effectively with management, team members, clients and vendorsDesired:  Driven; high ethical standards; enthusiastic team member; critical mind; invested in project; highly detailed oriented; bright; fast learner; proactive vs. reactive.

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