Oncology CRA, Northeast Region

Responsibilities: Develop and maintain strong relationships with investigative sites and client personnel. Conduct onsite monitoring visits to ensure study activities are conducted in accordance with protocols, SOPs, FDA regulations, ICH GCP, and applicable local requirements. Monitor sites for the accuracy, completeness, and validity of patient records, clinical notes, and study data. Support site initiation activities and ongoing site management throughout the clinical trial. Provide regular trial status updates and progress reports to the Trial Manager and client. Manage and maintain required study data and documentation in accordance with applicable regulatory requirements. Ensure sites are following applicable SOPs, protocols, and regulatory requirements. Assist with preparation for and participation in client audits and regulatory inspections. Identify, communicate, and help resolve site-level issues and study-related challenges. Support the successful execution of clinical trials within assigned sites and region. Travel regionally to assigned investigative sites as required. Qualifications: 2-3+ years of Clinical Research Associate experience preferred. Prior onsite monitoring experience is required. Strong Oncology clinical research experience required; candidates with heavy, in-depth Oncology CRA experience are strongly preferred. Experience with site initiation activities preferred. Strong knowledge of FDA regulations, ICH GCP, and applicable local regulations . Experience working directly with investigative sites and study teams. Strong communication, organizational, and relationship-management skills. Candidates transitioning from a Clinical Research Coordinator role into an Oncology CRA/monitoring position may be considered. Bachelor's degree or equivalent experience required.