Clinical Research Associate – Part time Contractor

Research AnalystResearch AnalystPart TimeRemoteMid LevelTeam 1,001-5,000Since 1967H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

4 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical Research Associate – Part time Contractor

NAMSA

• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned.

Job Requirements

  • Fluency in English and local language, if different, required.
  • Higher education degree or equivalent education, training, and experience.
  • Preferred 2 years clinical trial experience.
  • Preferred monitoring experience.
  • Able to work independently once trained.
  • Good verbal and written communication skills.
  • Strong organizational skills.
  • Basic computer proficiency.
  • Understanding of clinical research processes and regulations.
  • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.

Benefits

  • Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.
  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
  • Extensive use of a computer keyboard.

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