Sr. Clinical Research Associate
$131,000–$150,000 year
Remote · United States
United StatesRemoteFull Time$131,000–$150,000 yearSenior LevelBachelors DegreeLarge
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Large
Job Summary
Sr Clinical Research Associate responsible for managing and monitoring clinical studies in assigned sites under COPM, including site qualification visits, development of study monitoring plans, ISF preparation, site recruitment monitoring, training of CRA teams, data quality in e-CRF, deviation and AE/SAE management, regulatory submissions under supervision, budget/contract support, and participation in audits/inspections; travel up to 60% with remote work option.
Required Qualifications
- Bachelor’s degree or equivalent education/experience
- 5+ years of Clinical Operations experience (including Clinical Research Associate roles)
- Knowledgeable of current FDA and IRBs regulatory requirements and guidelines governing clinical research
- Ability to oversee, manage and communicate effectively with clinical sites
- Strong attention to detail, establish priorities and meet deadlines
- Ability to work independently and take initiative
- Strong knowledge of applicable computer software applications
- Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships
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