Spec 2, Clinical Operations, Clinical Research Associate - Onsite
About The Position
The Clinical Research Associate (CRA) will provide cross-functional operational support throughout the study lifecycle. This role involves investigating data or documentation discrepancies, contributing to process improvements to reduce recurrence during study conduct and closeout, and supporting study start-up activities. The CRA will perform remote monitoring visits and collaborate with site personnel, IRBs/ECs, contractors/vendors, and internal company personnel. Building and maintaining strong working relationships with internal partners and site personnel is crucial for supporting enrollment, data quality, and site performance. The role also includes assisting with site remediation activities and completing relevant training.
Requirements
- Bachelor's Degree or Equivalent Life Sciences or Nursing
- 3-4 years in clinical research (as a CRC or CRA)
- Experience in quality assurance/control and regulatory compliance
- Experience in the healthcare industry
- Experience with electronic data capture
Nice To Haves
- Viva experience or like platform
- Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)
Responsibilities
- Provide cross functional operational support throughout the study lifecycle, investigating data or documentation discrepancies and contributing to process improvements that reduce recurrence during study conduct and closeout
- Support and coordinate study start up activities, including tracking site readiness, managing essential document collection, and communicating with sites regarding planning and logistics for Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs)
- Perform remote monitoring visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study monitoring plan
- Support, interface, and collaborate with site personnel, IRBs/ECs, contractors/vendors, and cross-function company personnel
- Build and maintain strong working relationships with internal partners (Clinical Operations, Regulatory Affairs, Quality, R&D) and site personnel (Investigators, CRCs, research nurses) to support enrollment, data quality, and site performance
- Assist with any site remediation activities, as applicable
- Complete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training
- Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas
Benefits
- Domestic travel - 3 sites per year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
