Senior Clinical Research Associate
Westwood, MA · Healthcare
$110,000 - $125,000 (- Yearly) 8% bonus, 6% 401k, 4 weeks PTORelocation assistance available Every year, healthcare systems run millions of clinical tests to help identify the causes of certain symptoms their patients are experiencing. This marketplace is rapidly growing/evolving, with cutting edge technology, machines, and rapid testing solutions at physicians fingertips.This role is within a leading medical diagnostic company.
Job Description
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, add’l research, 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 support.
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.
Key responsibilities:
Initiate, design and coordinate studies; collecting data to support submissions to regulatory and future product development
Ensure the execution of clinical trials with the goal of adhering to target timelines, budget and quality
Operate at a high level independently, partnering with other CRAs internally and directly reporting to the Director of Clinical/RA
Manage clinical trials; protocol, ICF and CRF development, investigational product / supply management, budget / contract negotiation and regulatory document collection/management
Monitor studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, utilizing knowledge of the diagnostic area sufficient to perform source data verification and monitor study protocol conduct / compliance
Working knowledge of GCP and SOPs to assure compliance with FDA regulations and applicable processes and procedures
Anticipate and identify problems/issues implement resolutions or provide recommendations for corrective actions in relevant job areas
Qualifications
Experience
Bachelor's Degree in life science discipline desired, other degrees will be considered
4-12+ years experience in clinical research / trial management in a hospital, lab, or R&D environment.
Experience with cardiac-focused clinical studies preferred
CCRA certification with ACRP or SoCRA desired
Medical Technologist or similar (MT/MLT) highly preferred
Must have medical device experience OR medical/hospital laboratory experience
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