Senior Clinical Research Associate
W
WEP ClinicalClinical Research
Remote, USFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5–7+ years
- Required Skills
- MS OfficeData management
Requirements
- Bachelor’s degree (life sciences, nursing, or related field preferred).
- 5–7+ years of experience conducting on-site and remote monitoring visits.
- Broad therapeutic exposure across multiple study types and indications.
- Strong technical and scientific aptitude with the ability to execute clinical protocols.
- Advanced organizational skills to manage multiple sites and protocols within budget.
- Proven ability to train, coach, and mentor clinical research staff.
- Proficiency with MS Office and EDC systems.
- Willingness to travel up to 80%.
Responsibilities
- Contribute to the design and review of study documents including protocols, CRFs, ICFs, and study plans.
- Lead site feasibility activities, conduct SQVs, and recommend sites for selection.
- Plan and conduct SIVs, routine monitoring, and close-out visits in accordance with protocol and ICH-GCP requirements.
- Build and maintain relationships with site staff, providing ongoing guidance and training.
- Verify source data and CRFs to maintain audit-ready site files.
- Manage IP accountability, safety event documentation, and protocol deviations.
- Lead monitoring activities for complex studies, including developing study-specific monitoring documents and acting as a primary point of contact for PMs and sponsors.
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