Clinical Research Manager
Comprehensive Cancer Center - Clinical Trial Operations
University Job Title: Clinical Research Manager
Bargaining Unit: None - Not included in the union (Yale Union Group)
Time Type: Full time
Duration Type: Regular
Compensation Grade: Administration & Operations
Compensation Grade Profile: Manager; Program Leader (M5)
Total # of hours to be worked: 37.5
Work Week: Standard (M-F equal number of hours per day)
Work Location: Medical School Campus
Worksite Address: 2 Church Street South Doctor's Building
New Haven, CT 06519
Work Model: Hybrid
Position Focus: This position is working a Hybrid schedule. Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). The Clinical Research Manager (CRM) is responsible for managing the Oncology Disease Group or Smilow Care Center staff members within the Clinical Trials Office (CTO) of Yale Cancer Center (YCC) and ensures appropriate infrastructure to conduct clinical trials in accordance with the study protocol and applicable policies and regulation while ensuring participant safety.
Essential Duties:
- Manages and monitors policies, practices and procedures of clinical research staff responsible for the implementation, management (including protocol updates / amendments), and quality conduct of clinical trials according to study protocols and Good Clinical Practice guidelines.
- Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research staff.
- Serves as a subject matter expert on protocol management and study subject recruitment.
- Collaborates with CTO Clinical Trials Project Manager and Principal Investigator (PI) on assessment and operational implementation of highly complex trials clinical research protocols.
- Ensures infrastructure to conduct clinical trials by evaluating the clinical, physical, technological, and staff resources required.
- Manages oversight of protocol conduct and ensures compliance with Good Clinical Practice guidelines.
- Develops, implements, and champions internal practices that ensure compliance with federal requirements.
- Serves as a critical resource before and during audits/inspections.
- Contributes to the review and refinement of CTO standard operating procedures (SOPs).
- Coordinates with Clinical Trials Project Manager to resolve congruency issues in a timely manner.
- Coordinates, oversees and participates in meetings including but not limited to Pre-study Visits, Site Initiation Visits, Monitoring.
- Other duties as assigned.
Required Education and Experience:
Bachelor’s degree in a health-related discipline, or other related field and a minimum of five (5) years of demonstrated experience in clinical trials research or the equivalent combination of education or demonstrated experience.
Required Skills/Abilities:
- Communication, leadership and team building skills.
- Ability to ensure appropriate infrastructure for clinical trials.
- Strong knowledge of Good Clinical Practice guidelines.
- Ability to provide proactive, flexible, and customer service focused advice.
- Ability to manage several projects concurrently and balance competing priorities.
Preferred Education, Experience and Skills:
Demonstrated experience supervising staff. Demonstrated experience with oncology clinical trials strongly preferred.
Preferred Licenses or Certifications:
ACRP/SOCRA (or equivalent) certification preferred. Willingness to obtain within one year.
Weekend Hours Required? Occasional
Evening Hours Required? Occasional
Drug Screen: No
Health Screening: No
Background Check Requirements: All candidates for employment will be subject to pre-employment background screening for this position.
COVID-19 Vaccine Requirement: The University maintains policies pertaining to COVID-19.
EEO Statement: University policy is committed to affirmative action under law in employment.
Note: Yale University is a tobacco-free campus.
