Protocol Activation Coordinator-YCCI
Reporting to the Yale Center for Clinical Investigation (YCCI) Associate Director for Clinical Research, the Specialist is responsible for ensuring that the Yale Cancer Center’s portfolio of clinical trials successfully progresses through the Institutional and Departmental requirements necessary for full approval and activation while achieving all procedural timelines and metrics. Provides a high level of technical and regulatory expertise and guidance to research faculty and staff, YCC disease teams and any required subcontractors in accordance with the current Food and Drug Administration (FDA) Regulations/ Guidance and Yale policy.
1.Directs and leads the system of processes necessary for protocol activation for an assigned portfolio of protocols. 2. Manages, as necessary, and in partnership with the relevant PI (or their designee) communication and expectations with/between PIs, faculty, research staff, nurses, Departments, Chairs, Industrial/External Sponsors/Funders and all divisions involved in protocol activation. 3. Notifies Principal Investigators and Clinical Research Managers (and others as needed) of protocol activation status throughout the entire activation process through metrics, dashboards, and reporting. 4. Tracks protocols as they move through the review process; notifying necessary staff and Leadership as required on any individual protocol or Disease Team which may not be achieving institutional benchmarks for compliance or timeliness of activation. 5. For assigned portfolio of protocols and in partnership with the relevant PI (or their designee), ensure all required regulatory and institutional reviews and approvals, budgets, contracts, logistic and feasibility reviews, site initiation visits, order sets, CTMS calendars and drug/device are in place (if applicable) and all regulatory and institutional activation steps have occurred. 6. Liaise with regulatory staff and other teams who submit protocols to research oversight committees, teams and departments per institutional guidelines to meet time to activation expectations while ensuring high quality of submissions, ensuring that all protocol documents are clear and comply with Federal Regulations and Institutional policies. 7. Advise, assist, and guide PI and process owners in appropriate responses to sponsors, strategic partners, committee(s) and units regarding delays in study activation as appropriate 8. Escalate delays/problems/issues to Leadership, as needed. 9. Communicate effectively and accurately with research team/PI and all involved in the study regarding target and actual timeline for protocol activation for any individual trial in assigned portfolio. 10. Coordinate across internal process owners, service providers and other regulatory bodies. Serve as liaison to the leadership and officers and other key internal and external collaborators with respect to assigned portfolio to accelerate the activation of research/clinical trials. 11. Assist in the development and lead and oversee deployment and use of technology platforms to allow enterprise-wide management of activation process and portfolio management. Keep current of all technological advancements across relevant Yale systems to facilitate programmatic and strategic initiatives to ensure Yale remains competitive nationally as a research leader. Maintain excellent working relationships with all relevant internal support groups vendor representatives including Epic, Forte, Huron, and others to ensure Yale’s needs are addressed as vendors plan for platform development and enhancements across their customer base. Train end-users on technology platforms. 12. Keep current of all current Federal and International regulations appropriate for advanced development of investigational products and devices. 13. Perform ongoing process improvement to continually decrease the time to study activation. Identify opportunities for efficiency gaining and elimination of redundancies in the activation process.
Required Education and Experience
Bachelor’s degree and 2 years of experience in clinical research management or project management or an equivalent combination of education and experience.
Required Skill/Ability 1:
Ability to effectively communicate verbally and in written form.
Required Skill/Ability 2:
Ability to form strong collaborative relationships as part of multi-disciplinary teams across functional boundaries.
Required Skill/Ability 3:
Ability to enhance the effectiveness and efficiency of a business process, with emphasis on management by influence rather than management by authority.
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.
Affirmative Action Statement:
Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: email@example.com.