Clinical Research Site Manager-Oncology

The Site Manager will oversee Clinical Research Coordinators (CRC) and Research Assistants (RA) as assigned. Arranges all aspects of the assigned clinical research trials, communicate with CRAs and sponsors, and reports directly to the Site Operations Manager associated with this Job Location. This role involves protocol management, regulatory compliance, study coordination, real-time quality data, budget oversight, team supervision, and effective communication with stakeholders. Essential Functions: 1. Clinical Operations & Protocol Oversight Provide operational leadership to Clinical Research Coordinators (CRC) and Research Assistants (RA) for oncology clinical trials across assigned satellite sites. Ensure timely and compliant study start-up, activation, enrollment, conduct, and close-out. Oversee protocol feasibility assessments, site selection input, and study implementation strategies. Ensure adherence to sponsor protocols, Clinical Trial Agreements (CTAs), and site SOPs. Monitor enrollment metrics, screen failure rates, and accrual targets; implement corrective strategies as needed. Oversee infusion-and non-infusion-based oncology trials, ensuring appropriate coordination with pharmacy and infusion nurses and other protocol-required services 2. Regulatory Compliance & Governance Ensure full compliance with ICH-GCP guidelines, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), HIPAA, and applicable state laws. Oversee IRB submissions, continuing reviews, amendments, safety reporting, and regulatory document maintenance. Ensure audit readiness at all times (sponsor, CRO, FDA, internal quality audits). Lead preparation and response for monitoring visits, audits, and inspections. Maintain CRC and RA-related oversight of delegation logs, training logs, and essential regulatory binders (electronic and paper as applicable). 3. Team Leadership & Performance Management Directly supervise Clinical Research Coordinators (CRCs) and Research Assistants (RAs). Conduct hiring, onboarding, training, performance evaluations, and corrective action as needed. Ensure CRCs conduct real-time data entry and documentation in approved eSource and, when assigned, EDC systems. Foster a culture of accountability, patient safety, collaboration, and continuous improvement. Provide ongoing oncology-specific education and protocol training to team members. 4. Patient Safety & Study Conduct Oversight Ensure informed consent processes are conducted ethically and in accordance with protocol and regulatory requirements. Oversee adverse event reporting, SAE reporting, and safety follow-up. Ensure proper investigational product handling, storage, accountability, and documentation. Monitor protocol deviations and implement corrective and preventive action plans (CAPAs). 5. Data Integrity & Quality Management Oversee accuracy, completeness, and timeliness of data entry, including ‘real-time’ data entry in eSource systems. Ensure source documentation supports all clinical trial data and billing compliance. Implement internal quality control checks and data review processes. Track and reduce data queries and protocol deviations across sites. 6. Financial & Budget Oversight Assist in study budget development and feasibility assessments. Monitor study financial performance, including invoicing, sponsor payments, pass-through expenses, and site-level margins. Ensure timely submission of sponsor invoices and reconciliation of study-related expenses. Collaborate with Site Operations Manager on resource allocation and staffing ratios based on study volume 7. Sponsor & Stakeholder Communication Serve as primary operational contact for sponsors and CROs at assigned sites. Participate in Sponsor Qualification Visits (SQVs), Site Initiation Visits (SIVs), and Investigator Meetings. Maintain strong communication with Principal Investigators, sub-investigators, pharmacy, infusion nursing staff, and administrative leadership. Provide regular operational and enrollment updates to Site Operations Manager. 8. Process Improvement & Strategic Growth Identify workflow inefficiencies and implement process improvements. Support expansion of oncology research services at satellite sites. Contribute to strategic planning for growth in oncology trials and infusion-based studies. Support implementation of new clinical research technologies and systems. Ensure consistent SOP adherence across all assigned oncology satellite clinics. Standardize documentation practices, regulatory maintenance, and quality controls. Support cross-training and coverage planning to ensure continuity of operations Education/Experience/Skills: Education: Bachelor's Degree preferred Licensure and/or Certification: CCRC or equivalent desired, Phlebotomy Experience: Four or more years of progressive experience in clinical research coordination, Six years or more in clinical research experience; Oncology and/or other infusion-based experience strongly preferred Knowledge/Skills/Abilities: Strong knowledge of regulatory requirements, Excellent organizational and interpersonal skills, Proficiency in relevant clinical research software #J-18808-Ljbffr Green Key Resources