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Senior Clinical Research Associate
Exact SciencesSenior Clinical Research Associate managing site deliverables and providing CRA guidance. Executing and conducting projects for clinical study plans at Exact Sciences.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Execute, manage and conduct projects associated with the company clinical study plans.
- Responsible for site management deliverables on assigned protocols and may 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 and remain current with project requirements.
- Support the Clinical Study Manager in developing study-specific training materials.
- Conduct thorough site qualifications visits and efficient site initiation visits.
Requirements
What you’ll need- 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.
- Meticulousness with a focus on accuracy and precision in all tasks and activities.
- Demonstrated ability to work well within a team and convey information effectively.
- Authorization to work in the United States without sponsorship.
Benefits
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical research monitoringdata managementdata entrydata validationdata cleaninginformed consent proceduresadverse event reportingdocumentationrecord-keeping
Soft Skills
meticulousnessaccuracyteamworkcommunication