SENIOR CLINICAL RESEARCH ASSOCIATE - WEST COAST at The Judge Group Inc. in Boston, Massachusetts

Posted in Other 4 days ago.





Job Description:

Location: REMOTE

Description: Our client is currently seeking a SENIOR CLINICAL RESEARCH ASSOCIATE - WEST COAST



This job will have the following responsibilities:



CLINICAL SITE MONITORING AND MANAGEMENT:-


• Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial


• Conducts site visits including but not limited to Pre-study visits, initiation visits, interim monitoring visits, close-out visits to ensure compliance with protocols, Sponsor SOPs, ICH/GCP and all applicable regulations


• Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate, and unbiased; subjects' rights, safety, and well-being are protected


• Collects, reviews, and monitors required regulatory documents for study start-up, study maintenance, and study close-out


• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, missing data and data queries, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance


• Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per protocol to upper management


• Performs investigational product accountability through physical inventory and record review


• Participates & provides inputs on site selection activities


• Supports audit/inspection activities as needed.

Qualifications & Requirements:




  • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
  • Demonstrated high level of monitoring skill with independent professional judgment.
  • Demonstrated understanding of medical/therapeutic area knowledge (oncology) and medical terminology
  • Knowledge of e-TMF and CTMS set up and maintenance processes
  • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
  • Excellent written and verbal communication skills including good command of English
  • Proven skills in site management including independent management of site performance and patient recruitment
  • Effective time management and organizational skills
  • Ability to establish and maintain effective working relationships with coworkers



Contact: arawat@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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