What are the responsibilities and job description for the 1099 Clinical Research Associate Consultant position at BioPhase?
- 1099 CRA Consultant -
- 40/hrs a week
- West Coast Candidates - 70% travel required
Growing biotech company seeking a Contract Senior Clinical Research Associate (1099 CRA) to support global and regional clinical trials
- Responsible for monitoring Phase I–III clinical studies from start-up through closeout
- Conduct site qualification, initiation, interim monitoring, and closeout visits
- Ensure studies are conducted in compliance with protocol, ICH-GCP guidelines, and regulatory requirements
- Review informed consent forms, protocol deviations, and support IRB/regulatory activities
- Support data review, query resolution, source document verification (SDV), and overall site compliance
- Assist with vendor coordination, central labs, imaging vendors, study drug tracking, and audit readiness
- Maintain study documentation within CTMS, EDC, IRT, and eTMF systems including Veeva Vault
- Collaborate cross-functionally with study teams, sites, and vendors to support timelines and data quality
- Support site training and foster strong investigator/site relationships
- Ideal candidates will have 5 years of CRA monitoring experience within biotech, pharma, or CRO environments
- Experience supporting Phase I–III clinical trials and remote monitoring activities requiredStrong understanding of FDA regulations, ICH-GCP guidelines, and clinical operations processes
- Proficiency with systems such as Veeva Vault, CTMS, EDC, and IRT preferred
- Must have strong communication, organizational, and problem-solving skills with the ability to work independently
- Domestic travel up to approximately 70% required
Salary : $110 - $125