New Haven, Connecticut
Washington, D.C.
New Haven, Connecticut
Chapel Hill, North Carolina
New York, New York
New York, New York
Northern & Central California, California
Posted: 01-Mar-23
Location: New Haven, Connecticut
Type: Full Time
Salary: 60,500 - 100,700 MP23
Categories:
Certifications:
Salary Details:
Preferred Education:
Essential Duties
1. 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. 2. 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. 3. 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. 4. 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. 5. Designs and implements quality control measures to ensure accurate collection and processing of data. 6. 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. 7. Abstracts concomitant medications from medical records. 8. 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. 9. Monitors federal and state regulations for new guidance, updates, or policies. 10. 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. 11. Participates in interim monitoring visits, internal audits and external audits/inspections. 12. 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. 13. Serves as a resource and provides technical assistance to investigators and their staff. 14. Provides analytical and technical support related to establishing and recording protocol congruency. 15. 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:
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.
