Principal Clinical Research Associate - Remote

Overview

The Principal Clinical Research Associate (PCRA) is an integral member of the clinical study team, effectively managing multiple priorities to ensure successful execution of clinical monitoring. PCRAs have expertise in on-site and remote clinical trial monitoring and oversight, ensuring subject safety, protocol compliance and data integrity, and implementation of clinical trial documents and plans. As an Avidity representative in the field, the PCRA will support establishing, building, and maintaining collective relationships with KOLs, investigators and site staff. The PCRA is relied upon to instill, promote, and maintain a culture of organizational excellence and monitoring team collaboration. Strong initiative, organizational skills, and leadership by example required.

In Short

• May review data quality reports for trends and escalation of monitoring issues.
• Assist clinical trial team with oversight of CRO monitoring activities, assumptions, and metrics, including site qualification, site initiation, interim monitoring, and close out visits.
• Conduct Oversight Visits to assess the Clinical Research Associate (CRA) and/or site performance to evaluate data integrity, compliance with the protocol, Good Clinical Practice (GCP), and any applicable local/regional regulations.
• Participate in User Acceptance Testing (UAT) for EDC, IRT, and study vendor portals.
• Collaborate, develop, and deliver study-specific training for CRO clinical study team, field CRAs, investigative site staff, and vendors.
• Assist with planning and attend investigator meetings (IM); may present during CRA training.
• Assist with investigative site regulatory inspection preparation, support, and follow-up.
• May participate in vendor capabilities presentations and bid defense meetings for vendor identification and selection.
• Contribute to ongoing process improvement and department initiatives.
• Travel as needed per study status and timelines.

Requirements

• Bachelor’s Degree or equivalent combination of education and experience in science or health-related field. Advanced Degree preferred.
• 8+ years of industry experience conducting clinical site monitoring, management, and oversight.
• Knowledge of regulatory and compliance requirements for clinical research.
• Team leadership experience within a cross-functional matrix environment.
• Demonstrated excellent presentation, communication (oral and written), teamwork, organizational, interpersonal, and critical thinking skills.

Benefits

• The base salary range for this role is $169,100 - $186,900.
• Avidity offers competitive compensation and benefits including annual and spot bonuses, stock options, and a 401(k) with an employer match.
• Comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development with various programming and education reimbursement.