Spec 2, Clinical Operations, Clinical Research Associate - Onsite (Exp in Regulated Industry)

Job Description

Role Purpose

• Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.

Essential Job Functions

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.
• Auxiliary responsibilities may include assisting 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

Requirements

• Bachelor's Degree or Equivalent Life Sciences or Nursing
• 3-4 years in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry
• Experience with electronic data capture.

Preferred

• Licenses and Certifications: Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)