Senior Clinical Research Associate - Boston, Massachusetts United States - 33250



JOB DESCRIPTION

Job #: 33250
Title: Senior Clinical Research Associate
Job Location: Boston, Massachusetts - United States
Employment Type:
Salary: contact recruiter for details
Other Compensation: 8% bonus
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


What makes this role unique: This is a "full-lifecycle" CRA role - you won't just be in a CRO-setting running tests, or doing a piece of the Clinical Research - you will own/manage all aspects of clinical trials for a product line, or multiple products, handling all aspects from site/test set-up, initiation/design/coordination of the study, execution of the trials (in hospital laboratories - not CRO's), ensuring timeline/budget/quality, document collection/mgt, and being the SME regarding any problems/resolutions during the trials. This is a fast-paced, hands-on position seeking a confident CRA who is ready to take on more responsibility. 

JOB DESCRIPTION

Senior Clinical Research Associate

Remote Role - But must reside within <3 hours of Boston, MA (relocation paid)

Competitive Pay, 8% bonus, 6% 401k, 4 weeks PTO

What makes this role unique: A 10+ year client of ours has acquired an exciting technology company and is ramping up to commercialize the product; development, research, mfg, engineering, operations, clinical, regulatory, etc – all of this ground-floor opportunities to create & build, but have the stability of working for a multi-billion dollar profitable business! Start-up feel, big-business backing and support. This role is within a leading medical diagnostic company, that offers cutting edge technology, machines, and rapid testing solutions at physicians’ fingertips.

In this fun challenging role, you will design, initiate, coordinate studies to support regulatory submissions for product development. You’ll ensure execution of clinical studies; focusing on tight timelines, budget, quality factors. This is a fast-paced, hands-on position seeking a confident CRA who is project-focused, and ready to take on more responsibility.

QUALIFICATIONS

Experience

  • Bachelor's Degree in life science discipline desired, other degrees will be considered
  • 5+ years experience in clinical research / trial management in a hospital, lab, or R&D environment.
  • IVD, Lab Diagnostics, or Medical Instrumentation experience required.
  • Sponsor experience required
  • Experience with cardiac-focused clinical studies preferred
  • CCRA certification with ACRP or SoCRA desired
  • Medical Technologist or similar (MT/MLT) highly preferred
  • Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical trial reports, etc.)
  • Demonstration of effective oral communication skills with clinical sites, and internal / external personnel from various departments / levels
  • Ability and willingness to travel, domestic and international, depending upon project need, periodically up to 30-50% domestically
  • Experience with Pre-Subs and 510k submissions desired but not required

Education:
University - Bachelor's Degree/3-4 Year Degree

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