The Clinical Research Support Laboratory (CRSL) is the primary non-CLIA certified laboratory responsible for collecting, processing, stabilizing, documenting, shipping and tracking all research biospecimens from patients participating in therapeutic clinical trials supported by the Yale Cancer Center Clinical Trials Office.
Reporting to the Assistant Director of the Clinical Research Support Laboratory, the Project Manager (PM) is responsible for managing the central research specimen requirements for the DART’s portfolio of studies, and depending on scope, in some cases may support more than one DART. The PM is responsible for conducting feasibility assessments of the protocols prioritized for activation by reviewing the study protocol, laboratory manuals, and other documents related to the central research specimen collections to determine the necessary resources required to conduct the study at the Smilow Cancer Hospital in New Haven and the Smilow Cancer Hospital Care Centers.
In partnership with the Clinical Trial Team Managers (CTTM) of the Disease Aligned Research Teams (DART), the CRSL Project Manager provides feedback on any findings that may preclude the ability to operationalize the central research specimen requirements. Additionally, to maximize efficiencies as well as adherence to study requirements, the CRSL Project Managers may create communication tools and templates highlighting critical laboratory criteria, such as handling requirements, processing times, shipping instructions, tracking logs, manifests, and other pertinent information on a study and visit-specific level to ensure compliance. The PM participates in regular meetings with research staff, meets with external study monitors, obtains updates and amendments on current clinical trials to maintain the relevant lab materials throughout each study, creates, submits, and reviews Epic builds outlining the required research collections to ensure PI oversight, works with the lab staff to ensure tracking and shipment of specimens to the external central lab sites; provides study-specific training and overviews to CRSL staff to ensure adherence to study protocol, provides direction to CRSL research staff responsible for managing the schedule of collections and inventory of kits and supplies, and may provide supportive coverage for Care Center CRSLs to process and ship specimens.
1. Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols. 2. Documents established congruency between funding proposals and approved protocols. 3. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols. 4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. 5. Attends meetings and presents issues when necessary that were identified during congruency review. 6. Serves as a resource and provides technical assistance to investigators and their staff. 7. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed. 8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements. 9. Develops, implements, and manages internal practices that ensure compliance with federal requirements. 10. May perform other duties as assigned.
Required Education and Experience
Bachelor’s degree in a relevant academic/scientific field and a minimum of 3 years of related research support experience; or the equivalent combination of education or experience.
Required Skill/Ability 1:
Strong analytic and critical thinking skills. Proven ability to comprehend complex clinical trial protocols, laboratory manuals, and associated materials with a demonstrated ability to interpret and extract relevant information.
Required Skill/Ability 2:
Proven ability to manage several projects concurrently, while balancing competing priorities and deadlines. Extreme flexibility in work focus. Ability to switch among several different projects without any adverse effects.
Required Skill/Ability 3:
Excellent time management and organizational skills, and attention to detail. Strong interpersonal skills and demonstrated ability to report on the status of project deliverables, and relay information to, and obtain information from, internal Yale staff as well as external study staff.
Required Skill/Ability 4:
Demonstrated knowledge of medical and laboratory terminology. Proven ability to work in a laboratory, preferably in a BSL-2 laboratory. Ability to travel to different laboratory locations and to transport laboratory supplies and specimens via motor vehicle to other sites; a valid driver’s license and the ability to use one's own motor vehicle is required.
Required Skill/Ability 5:
Strong proficiency with MS Office: Word, Excel, PowerPoint; ability to learn and work within OnCore, EPIC, and other integrated systems.
Preferred Education, Experience and Skills:
Master’s degree in health or research related discipline and two years of related work experience in a similar job family. Experience must indicate ability to work with minimal supervision in a team atmosphere and receptiveness to direction. Previous clinical trials experience and/or experience in an oncology setting.
Ability to lift 30 pounds. Ability to walk up to a mile throughout the various campuses and facilities to retrieve supplies and patient specimens as needed.
Preferred Licenses or Certifications:
Certified Clinical Research Professional (CCRP) or equivalent.
Weekend Hours Required?
Evening Hours Required?
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.
Additional Background or Health Screening Requirements
Selected incumbent must have successful completion of a DMV check, a valid driver’s license and a car available.
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: firstname.lastname@example.org.
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