School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Overview

For the Duke Cancer Institute [DCI] coordinate the day-to-day activities of the Protocol Review and Monitoring Committee [PRMC] in compliance with Duke Policies and the National Cancer Institute’s [NCI] requirements for the Cancer Center Support Grant [CCSG].

Responsibilities and Expectations
Program Support – 60% Effort

Responsible for triage and assignment of all cancer-related clinical research protocols submitted in the Duke electronic Internal Review Board [eIRB] system. Be an expert in the required information and application data for protocol submission. Serve as a liaison between the Principal Investigators [PIs], the research staff, the PRMC and the IRB to ensure all study submissions are completed and reviewed in a timely manner.

Identify problems and inconsistencies in individual study submissions and the overall PRMC review process; recommend corrective actions as appropriate.

Manage, conduct, and present a thorough and timely scientific and regulatory review of the underlying preclinical and clinical data supporting an oncology clinical research protocol. Assess the feasibility of oncology clinical trials and subject recruitment strategies during PRMC protocol review through database queries and inquiries directed at Principal Investigators (PIs), clinical trial managers, and Disease Group leaders.

Initiate, when indicated, an ad hoc review of scientific merit by PRMC members to facilitate the review of high priority protocols.

Attend PRMC and Institutional Review Board (IRB) meetings, as required, to expedite the protocol review process.

Review studies for compliance with Duke and NCI CCSG requirements. Assign protocols to PRMC members for review. Coordinate PRMC and IRB review and final sign off in eIRB.

Coordinate PRMC orientation and training for new PRMC members and the Oncology Clinical Research Units [OncCRU] clinical research staff in partnership with PRMC management. Follow standard operating procedures (SOPs) and optimize SOPs to collect clinical trial data in a cooperative and validated manner; monitor data quality with respect to accuracy, consistency, reliability, and reconciliation with other data sources; Take corrective actions when needed to protect data integrity.

Create and update tools for the development of high quality protocols, including but not limited to protocol templates and “best practice” summaries targeted to oncology research study teams and compliance checklists.

Administrative – 30% Effort

Coordinate the PRMC and IRB annual meeting schedules for DCI representatives.

Enter new protocols into the DCI Clinical Trials Management System [CTMS] based on study characteristics and the NCI’s CCSG categories.

Communication – 10% Effort

Coordinate communications within the organization on behalf of PRMC leadership.

Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Refer complex questions and escalate issues to others as appropriate.

Other work as assigned.

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.

The intent of this position description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities. You may be directed to perform job-related tasks other than those specifically presented in this description.

Qualifications Required At This Level

Education/Training

Work requires analytical, communications and organizational skills generally acquired through completion of a bachelor's degree program.

Experience

Work requires one year of experience in program administration or involving academic, instructional or counseling activities to acquire skills necessary to plan, coordinate and implement a variety of program activities and events.

Or an equivalent combination of relevant education and/or experience.

Skills

Ability to provide guidance and direction to subordinates, including setting standards and monitoring performance.

Skills using logic and reasoning to identify the strengths and weaknesses of alternative solutions to problems.

Skills evaluating program performance, summarizing findings, communicating results, and forming an action plan.

Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, and coordination of people and resources.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.