Clinical Research Coordinator
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer, and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention, and patient care, as well as community outreach and education.
The Clinical Trials Office is in a period of rapid growth and actively recruiting Clinical Research Coordinators. They will be responsible for planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. These activities include, but are not limited to patient screening, eligibility determination, registration and other protocol and subject milestones. The CRC will have direct patient contact and will be responsible for managing a multitude clinical trials. The CRC will be assigned to a specific disease team(s) upon hire based on the candidate’s background.
This Clinical Research Coordinator will staff the Trumbull, CT and Fairfield, CT Care Center locations.
- Manages and organizes assigned site studies. Serves as the primary organizer for assigned trials between University staff, Yale-New Haven Hospital staff, non-Yale collaborators, Sponsors, CROs, Investigational Drug Service, Clinical Research Support laboratory, diagnostic radiology, Clinical Trial Tissue Services, Yale Institutional Review Board and others involved in the conduct and oversight of human clinical research
- Tracks and reports adverse events, serious adverse events, protocol waivers, deviations and violations. Assists investigators in the preparation of corrective action plans and ensures implementation and adherence to stated plan.
- Documents and conveys study data. Supervises assigned staff to ensure that report forms are accurately documented and completed in a timely manner at each site location.
- Assists in ensuring principal investigator oversight by providing updates on protocol issues, obtaining signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required.
- Designs and implements quality control measures to ensure accurate collection and processing of data.
- Ensures adherence to protocol for all study participants throughout the duration of participation in the clinical trial. Identifies instances of noncompliance and deviations from protocol and reports noncompliance and deviations to the appropriate parties. Assists investigators and Clinical Trial Managers in the preparation and execution of corrective and preventative action plans.
- Abstracts concomitant medications from medical records.
- Maintains a high degree of knowledge on regulatory and policy requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements. Develops, implements, and manages internal practices that ensure compliance with federal requirements.
- Monitors federal and state regulations for new guidance, updates, or policies.
- Organizes and performs all research activities within the highest ethical, legal and scientific standards in accordance with federal, state and institutional regulatory requirements and policies.
- Participates in interim monitoring visits, internal audits and external audits/inspections.
- Monitors and audits follow-up letters, observation reports and other information to ensure all action items are responded to prior to the next scheduled interim monitoring visit.
- Serves as a resource and provides technical assistance to investigators and their staff.
- Provides analytical and technical support related to establishing and recording protocol congruency.
- Performs 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. Experience must indicate the ability to work with minimal supervision in a team environment.
Required Skill/Ability 1:
Demonstrated ability to create and follow research project related supporting documents.
Required Skill/Ability 2:
Proven ability to schedule and coordinate research activities as well as work with a team to develop action items and other means to keep projects moving along according to timeline.
Required Skill/Ability 3:
Demonstrated ability to report on the status of project deliverables and draft and submit project updates to the study sponsor.
Required Skill/Ability 4:
Strong clinical and analytical skills. Proven ability to evaluate and assess subject’s suitability for inclusion into studies, obtain informed consent, determine patient eligibility and coordinate patient enrollment.
Required Skill/Ability 5:
Excellent time management and organizational skills. Strong interpersonal skills with the proven ability to communicate effectively.
Preferred Education, Experience and Skills:
One year of Oncology clinical trial experience. Master’s degree in health or research-related discipline preferred. Experience indicating ability to work with minimal supervision in a team atmosphere and receptiveness to direction.
Preferred Licenses or Certifications:
Certification as a Clinical Research Associate or Clinical Research Professional (ACRP or SOCRA) preferred.
Drug Screen No
Health Screening No
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.
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