Oncology Research Manager

Newport News, Virginia

Overview

The Oncology Clinical Research Manager is responsible for leading and managing all RN and non-RN research coordinators across the oncology research program within the Riverside Cancer Care Network. The Oncology Clinical Research Manager also manages regulatory coordinators within the cancer network research program. Works closely with the various Principal Investigators (PIs), Service Line Administrator and Service Line Chief to ensure safety and meet all regulatory, clinical quality and financial requirements of the program. The Oncology Clinical Research Manager is responsible for protocol review, feasibility assessment, contract and budget review and negotiation, and study implementation within the Oncology Research Program. Functions as the clinical expert to manage and lead the clinical research endeavors for Riverside. Collaborates closely with physicians, service line leadership and operational areas for protocol selection and appropriate, targeted growth of the research program. Ensures the research program operates in compliance with principles of Good Clinical Practice and applicable federal, state and local guidelines for research. Responsible for enlisting and maintaining patients on research protocols via direct care coordination or support of other assigned staff responsible for direct care management.

What You Will Do

• Manages clinical research operations for all research staff in accordance with federal regulations. Responsible at the administrative level that all research activities are coordinated with all departments within the oncology practices and hospitals. Responsible for coordinating and providing protocol training. Works closely with physicians on facilitating patient recruitment to clinical trials. Maintain established relationships with outside sponsors. Develop new relationships for potential study opportunities.
• Facilitate/organize department meetings to discuss data, accrual, study patients, and workload. Encourage open discussion and problem solving. Communicates frequently with PIs and provides updates on items such as accrual, patients, SAEs, etc. Open communication with all physicians involved with research and provides support for all research activities. Provide updates to leadership.
• Supervises research work to include the following but not limited to listed duties - resource to research coordinators, train as needed, work as a coordinator, manage productivity/workload, compliance for studies and regulatory and work closely with physicians for study selection.
• Ensure budgets are entered in CTMS research software system to facilitate managing study budgets to include coordinating procedure payments, invoices and patient visits. Collaborates with Clinical Research coordinators for accuracy.
• Collaborates closely with RMG Medical Oncologists, Radiation Oncologists, Surgical Oncologists, Service Line Leadership and other Operational Areas. Maintains frequent open communication with PI on all protocol requirements and regulatory responsibilities. Demonstrates ability to build trusting collaborative relationships with patients and their families to facilitate subject retention. Maintain a professional courteous and considerate demeanor in all interactions with RMG practices, facility and support service team members, research team members, caregivers, patients and visitors. Establish and maintain collaborative relationships with outside Sponsors, CROs, and medical liaisons to identify potential opportunities for growth.
• Participates in and supports all site auditing/monitoring visits. Maintains protocol regulatory documents in compliance with federal regulations and applicable state regulations. Informs physicians and staff of audit/monitoring results as appropriate

Qualifications

Education

• Bachelors Degree, BSN (Required)

Experience

• 2 years experience in Research (Required)
• 2 years Oncology Research (Preferred)

Skills And Abilities

• Strong oncology research experience, strong oncology regulatory experience, knowledge of managing regulatory requirements to include: FWAs, NCI experience, pharmaceutical experience, reviewing of consents and making changes as appropriate.
• Expertise in managing audits to include preparation, site visits, interacting with auditors.
• Ability to mentor and be a resource to all oncology staff, to include onboarding new team members.
• Ability to manage data submissions per specific study timelines and accurate data entry.
• Strong experience in managing and tracking research finances for each specific study, strong written and verbal communication skills.

Licenses and Certifications

• Certified Oncology Nurse - Oncology Nursing Certification Corporation OCN (Preferred)
• Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals CCRC, ACRP or Certified Clinical Research Professional within 1 Year(Required)
• Registered Nurse (RN) - Virginia Department of Health Professions (VDHP) Upon Hire(Required)
• Valid Drivers License Required

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