One of our large MedTech clients is looking for a Clinical Research Scientist to join their team for a 12+ month project. This individual will support multiple class 3 device trials. They will develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision, plan for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures. They will partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables and will be responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and core teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP). This role will entail developing strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders and drafting study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions.
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-Strong experience independently writing protocols
-Experience writing informed consents
-5+ years of experience within MedTech or Pharma
-Experience working cross-functionally with "core teams"
-Clinical Operations background
-3+ years experience as a Clinical Scientist/Clinical PM
-Experience with either BOA, PMA, NDA submissions (FDA approval)
-Experience with PMCF plans
-MedTech experience (class 3)
-Global Trial experience
-Clinical Study Report writing
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.