Clinical Research Associate II- Government Sector
RemoteUnited States
Job Summary
Independently schedule and conduct remote and on-site monitoring visits, including qualification, initiation, routine, closeout, and for-cause visits. Perform source data verification, adverse event tracking, protocol deviation reviews, and facility tours while ensuring compliance with ICH GCP, SOPs, and applicable regulations. Document findings in site visit reports, facilitate action item resolution, and provide training to site staff on protocol and GCP guidelines. Serve as the primary point of contact for study site personnel to resolve issues, assist with IRB submissions, and support audit preparations. Collaborate with project teams to monitor site performance, track recruitment strategies, and ensure study materials align with regulatory requirements.
Required Qualifications
- Bachelor's Degree Scientific discipline
- 1-2 years of relevant monitoring experience (on-site and remote)
- Proficient with MS Office Suite
- Excellent computer and organizational skills
- High level of attention to detail
- Ability to work on varying projects and exercise critical thinking
- Self starter who can work remotely
- Team player who can work cross functionally with some oversight
- Knowledgeable in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines
- Excellent organizational, interpersonal, and communication skills both oral and written
- Demonstrated problem solving skills
- Self motivated, and adaptable to a dynamic environment
- Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities
- Ability to collaborate with internal and external colleagues and work well in a team oriented setting
Desired Qualifications
- Bachelor's Degree Scientific discipline preferred
- 2+ years of experience preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.