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Clinical Research Associate

System One
Rockville, MD
  • Posted: over a month ago
  • Full-Time
Job Description

Title: Clinical Research Associate  
Location: Remote - 50% travel 
Type: Full Time, Salaried with benefits 

Responsibilities: 

  • Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial (will be performing on site monitoring and remote monitoring)
  • 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
  • Work with in-house Clinical Trial Assistant to collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.

Requirements:

  • Bachelor's degree in Sciences from an accredited institution with strong emphasis in science and/or biology
  • Minimum of 2-3 years of clinical monitoring and direct site management experience in a bio/pharma/ Clinical Research Organization
  • Experience monitoring oncology trials is required (clinical trial coordination, study start up)
  • Applicants may be eligible to work remotely depending on location
  • Ability to travel domestically approximately 50% of working time
  • Current driver's license preferred 
  • COVID vaccination required 

System One

Address

Rockville, MD
USA

Industry

Healthcare

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