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CandelPosted 1 month ago

Clinical Trial Associate

$88,000–$100,000 year

HybridNeedham, Massachusetts, United States

Full TimeEntry LevelBachelors DegreeSmall

Job Summary

Execute day-to-day clinical trial operations for Phase 2 and Phase 3 trials, ensuring alignment with protocols, timelines, and regulatory requirements. Review, format, and finalize study templates, logs, plans, and manuals while overseeing personnel training. Collect and complete essential activities including data entry into multiple databases, source document verification, and quality control processes. Manage imaging vendors, track invoices, and coordinate sample delivery and recovery. Assist in planning study meetings, distributing updates, and supporting site management activities such as monitoring report reviews. Maintain study trackers and ensure timely data submission with appropriate progress reporting. Perform primary data reviews and database entry according to SOPs. Support invoice tracking, purchase order coordination, and budget-related activities. Requires a Bachelor's degree in a health-related discipline, at least two years of clinical research experience, and knowledge of GCP and FDA regulations. Must be authorized to work in the US.

Required Qualifications

  • Bachelor's degree in a health-related discipline or similar
  • At least 2 years of experience in the clinical research/pharmaceutical/biotech arena
  • Understanding of clinical research and the requirements of a clinical operations function
  • Excellent verbal and written communication skills
  • Good organizational and interpersonal skills
  • Team drive
  • Knowledge of GCP and FDA regulations related to clinical trial conduct
  • Familiarity with industry best practices
  • Able to manage multiple projects independently
  • Proficiency in using normal office software: Microsoft Word, Excel, and PowerPoint
  • Discretion in handling confidential information
  • Must be authorized to work in US
  • We cannot provide sponsorships

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