Spec 2, Clinical Operations, Clinical Research Associate

Bill rate $85 on site -4days Friday flexible.

Role Purpose

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

Essential Job Functions

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

Required

Bachelors 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)