IQVIA
Senior Clinical Research Associate - Oncology
IQVIA, Durham, North Carolina, United States, 27703
IQVIA is looking for a Senior Clinical Research Associate (CRA 1 or CRA 2) with at least 1.5 years of on-site oncology monitoring experience to join our team.
Key Responsibilities:
Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Collaborate with sites to develop and monitor participant recruitment plans to meet project objectives.
Deliver thorough training on protocols and related studies to assigned sites, maintaining regular communication to manage project expectations and address issues.
Assess the quality and integrity of site practices in accordance with protocols and applicable regulations; escalate quality concerns as needed.
Track study progress, including regulatory submissions, recruitment and enrollment figures, case report form (CRF) completion, and data query management.
Help manage site startup activities and ensure proper documentation is maintained in the Trial Master File (TMF) and Investigator's Site File (ISF).
Create and keep detailed records of monitoring visit findings and action plans by submitting regular reports and follow-up letters.
Work collaboratively with study team members to support project execution effectively.
May assist in the financial management of sites and the retrieval of invoices according to local requirements.
Qualifications:
Bachelor's Degree in a scientific or healthcare-related field is preferred.
1.5 to 2 years of relevant experience, including on-site monitoring in clinical trials.
Join IQVIA, a leading global provider of clinical research services, and contribute to the advancement of innovative medical solutions that enhance patient outcomes worldwide.
Location: Durham, North Carolina.