Clinical Research Associate II - North Carolina, East Coast
About the role
The Clinical Research Associate II (CRA II) position focuses on oncology clinical trials, specifically Phase 1, Phase 2, and Phase 3 studies. This role requires collaboration with cross-functional teams to ensure adherence to protocols, regulatory requirements, and high-quality standards.
Essential Functions
Study Initiation and Planning: Participate in study feasibility assessments and site selection processes. Assist in preparing and reviewing essential documents like informed consent forms (ICFs) and study manuals.
Clinical Trial Monitoring: Conduct site qualification, initiation, interim monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory guidelines. Regularly review Investigator Site Files (ISF) to maintain site audit readiness. Provide routine site communication, including resolving site issues and providing protocol training as necessary.
Leadership: Contribute to the development and delivery of CRA training materials. Mentor and support junior CRAs and newly onboarded CRAs. Review study documents including the Clinical Monitoring Plan and Investigator Site File documents. Participate in trial risk management meetings and procedures. Identify, develop, and implement process improvement initiatives to enhance monitoring quality and mitigate trial risks.
Data Collection and Management: Monitor and review clinical data to ensure accuracy, completeness, and timeliness. Work closely with data management teams to resolve data discrepancies and ensure data integrity throughout the trial.
Regulatory Compliance: Assist in the preparation of regulatory submissions and support inspections/audits as needed. Ensure that all clinical trial activities are conducted in accordance with applicable regulatory requirements and internal procedures.
Collaboration and Communication: Foster strong relationships with investigators, study coordinators, and other key stakeholders. Provide regular updates to internal teams and management regarding study progress, issues, and resolutions.
Qualifications
Education/Experience: Bachelor’s degree in life sciences or a related field; advanced degree (e.g., Master’s, PhD) preferred. Minimum 2 years oncology experience (or commensurate).
Knowledge / Skill / Ability: Proficiency in understanding clinical trial protocols, GCP, regulatory requirements, EDC, EMR, eTMF, and CTMSS. Strong organizational skills with attention to detail and the ability to prioritize tasks effectively. Ability to effectively and efficiently perform source data verification (SDV) whether remotely or onsite. Ability to identify protocol deviations and effectively identify root cause and assist sites in implementing corrective or preventative actions. Excellent communication and interpersonal skills, both written and verbal. Ability to manage complex protocols/sites and grow to lead other CRAs.