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Early Clinical Development Monitor

Company

Parexel

Address , Remote
Employment type
Salary
Expires 2023-10-03
Posted at 8 months ago
Job Description

United States of America, Remote
Additional Locations: Remote - United States of America
Job ID R0000014053

Category Clinical Trials


ABOUT THIS ROLE

Clinical Trial Quality
  • Identifies and records protocol deviations
  • Ensures site regulatory files are current, and verifies the timely submission of study documentation (including safety reporting)
  • Ensures sites meet performance expectations related to recruitment, enrollment, and retention
  • Responsible for monitoring clinical trial quality and site management for client sponsored studies that are not fully outsourced to a contract research organization (CRO)
  • Conducts site qualification, initiation, interim, and close-out visits
  • Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal/local regulations, and SOPs
  • Reviews site source documentation, case reports, and verifies accurate data capture
  • Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol
Site Management
  • Builds and maintains professional relationships with site personnel
  • Maintains ongoing communications with site personnel and assists with problem solving during all stages of study start up, conduct, and close out
  • Travels to clinical study sites as required, including remote or onsite visits globally
  • Analyzes issues and uses sound judgment to make decisions and escalates study related issues as necessary
Communication
  • Writes and submits timely and accurate monitoring visit reports, and study correspondence
Compliance with Parexel standards
  • Complies with timely completion of required training curriculum
  • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
  • Completes timesheets accurately as required
  • Submits expense reports as required
  • Updates CV as required
Skills:
  • Ability to learn client applications
  • Proficient in written and spoken English required
  • Effective communication, interpersonal skills, and the ability to build relationships
  • Analytical problem-solving experience, trouble shooting and resourcefulness
  • Working knowledge of clinical drug development process
  • Travel to be inclusive of regional, national and international as required
  • Familiarity with medical and clinical trial terminology
  • Proficient in local language, as applicable, preferred
  • Proficiency in widely used technologies
Knowledge and Experience:
  • Minimum of 5 years relevant industry experience
Education:
  • Bachelor’s Degree or equivalent is required

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.