Scientific Review Officer
This position is part of the Duke Cancer Institute’s [DCI] Cancer Protocol Committee [CPC]. Coordinate and conduct reviews of all cancer-related clinical research protocols at the DCI in a thorough and timely manner. The protocol review focuses on a protocol’s scientific merit, priority, and progress, with an emphasis on the background, rationale, pre-clinical, and clinical evidence that supports conduct of a proposed protocol. Responsible for ensuring scientific excellence, high ethical standards, and compliance with institutional, state, and federal regulatory obligations.
- Manage, conduct, and present a thorough and timely scientific review of the underlying pre-clinical and clinical data supporting an oncology clinical research protocol.
- Communicate with CPC Chairs concerning the review and sign-off of protocol reviews.
- Initiate, when indicated, an ad hoc review of scientific merit by CPC members to facilitate the review of high priority protocols.
- Attend CPC and Institutional Review Board (IRB) meetings, as required, to expedite the protocol review process.
- Coordinate timely communication between the CPC and IRB. Assist in improving integration of web-based CPC and IRB applications.
- Develop strong relationships and collaborations with CPC members, IRB leadership, DCI leadership, DCI Principal Investigators, DCI study teams, DCI clinical operations teams, and other key stakeholders, to ensure timely protocol reviews and the development and submission of high quality protocols.
- Monitor the progress of active oncology clinical trials to ensure the continued relevance of the science behind a clinical trial and the safety/ethical considerations of human subject participation.
- Organize CPC review efforts with those of the DCI Safety Oversight Committee, the DCI Monitoring Team, and the IRB to ensure proper oversight of oncology clinical trial conduct in terms of scientific impact, protocol validity, data integrity, regulatory compliance, good clinical practice, and human subject protections.
- Assist in tracking and management of the DCI clinical trials portfolio.
- Monitor protocol approval times through the CPC process for the purpose of demonstrating improved review efficiency.
- Assess the feasibility of oncology clinical trials and subject recruitment strategies during CPC protocol review through database queries and inquiries directed at Principal Investigators (PIs), clinical trial managers, and Disease Group leaders.
- 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, “best practice” summaries targeted to oncology research study teams, and compliance checklists.
- Perform outreach and host seminars to educate the DCI research community about the purpose and mission of the CPC, including overviews on the standards, requirements, and expectations of the CPC.
- Disseminate information to the DCI research community about DCI regulatory obligations to the NCI and other federally mandated considerations such as ClinicalTrials.gov.
- Understand and advocate for the role of research in the DCI.
- And 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.
Requisition Number: 401512712
Duke Entity: MEDICAL CENTER
Job Code: 2821 PROJECT PLANNER I
Job Family Level: 70
Full Time / Part Time: FULL TIME
Regular / Temporary: Regular
Duke University 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 essential job 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.
Bachelor's degree. Additional training in Project Management or related training is desired.
Two years of experience in project management, with increasing scope and independence. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
PhD with research experience preferred.
Auto req: ID106393BR