Clinical Research Associate II - Chicago, Midwest

Clinical Research Associate II (CRA II) Oncologist As a Clinical Research Associate II (CRA II) specializing in oncology, you will play a crucial role in the execution and management of Phase 1, Phase 2, and Phase 3 clinical trials. You will collaborate closely with cross-functional teams to ensure adherence to protocols, regulatory requirements, and high-quality standards throughout the clinical trial process.Qualified Candidates need to live in or near ChicagoEssential Functions Study Initiation and Planning: Participate in study feasibility assessments, and site selection processesAssist in the preparation and review of essential documents such as informed consent forms (ICFs) and study manualsClinical Trial Monitoring: Conduct site qualification, site initiation, interim monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory guidelinesRegularly review Investigator Site Files (ISF) to assist in maintaining site audit readinessPerform routine site communication, including resolving site issues and providing protocol training as necessaryLeadership: Contribute to development and delivery of CRA training materialsMentor and support junior CRAs and newly onboarded CRAs.Review study documents including the Clinical Monitoring Plan and Investigator Site File documentsParticipate in trial risk management meetings and proceduresIdentify, develop and implement process improvement initiatives to enhance monitoring quality and mitigate trial risksData Collection and Management: Monitor and review clinical data to ensure accuracy, completeness, and timelinessWork closely with data management teams to resolve data discrepancies and ensure data integrity throughout the trialRegulatory Compliance: Assist in the preparation of regulatory submissions and support inspections/audits as neededEnsure that all clinical trial activities are conducted in accordance with applicable regulatory requirements and internal proceduresCollaboration and Communication: Foster strong relationships with investigators, study coordinators, and other key stakeholdersProvide regular updates to internal teams and management regarding study progress, issues, and resolutions