Senior Clinical Research Associate
Exact Sciences
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $89,000 - $151,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- executing, managing and conducting projects associated with the company clinical study plans
- responsible for site management deliverables on assigned protocols
- act as a lead CRA for the study, providing guidance and support to other CRAs on the team
- establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies
- conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships
- serve as a point of contact for investigators and site staff
- maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates
- facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
- support the Clinical Study Manager to develop study-specific training materials
- conduct thorough site qualifications visits
- ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams
- conduct efficient and comprehensive site initiation visits
- document monitoring activities in monitoring visit reports and follow-up letters
- communicate serious issues to appropriate parties, in a timely manner
- ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed
Requirements
- Bachelor’s Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience
- Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience
- 4+ years clinical research monitoring experience or equivalent experience
- Proficiency in data management, including progressive experience in data entry, validation, and cleaning
- Familiarity with Electronic Data Capture (EDC) systems
- Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements
- Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices
- Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits
- Proficiency in monitoring plans, protocol adherence, and GCP guidelines.
Benefits
- paid time off (including days for vacation, holidays, volunteering, and personal time)
- paid leave for parents and caregivers
- retirement savings plan
- wellness support
- health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical research monitoringdata managementdata entrydata validationdata cleaningsite initiation visitsroutine monitoring visitsclose-out visitsmonitoring plansGCP guidelines
Soft skills
communicationleadershipteam supportrelationship managementtraining facilitationproblem-solvingorganizational skillsattention to detailtime managementcollaboration