STARS Requisition number
87673BR
Posting Position Title
Clinical Research Coordinator 2
Essential Duties
1. Serves as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols. 2. Manages, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration. 3. Contributes to study feasibility reviews and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes. 4. Ensures study protocols are adhered to, oversees the maintenance of accurate documentation, recruitment of study participants and regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements. 5. Identifies instances of noncompliance and deviations from protocol and reports and advises noncompliance and deviations to the appropriate parties. 6. Advises Principal Investigator through updates on protocol issues, status of signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required. 7. Analyses, documents and conveys study data. Collaborates with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner. 8. Oversees the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations. 9. Assesses trial execution program wide and identifies areas that need improvement or that require correction and provides education and/or recommendations, as needed. 10. Collaborates with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans in the preparation of corrective action plans and ensures implementation and adherence to stated plan. 11. Collaborates with the Quality Education Unit to contribute to the design of CRC trainings and continuing education. 12. Participates in interim monitoring visits, internal audits, and external audits/inspections. 13. Oversees the work and advises on protocol management and recruitment to CRC I development. 14. Monitors, interprets, and communicates federal and state regulations, and local policies for new guidance, updates, or policies. 15. Performs other duties as assigned.
Required Education and Experience
Bachelor’s degree in a health-related discipline, or other related field and two (2) years of clinical research experience, or the equivalent combination of education or experience. Minimum of one (1) year experience in clinical trials coordination. Knowledge of Good Clinical Practices (GCP) and Federal Regulations is required. Proven experience must indicate the ability to work with minimal supervision in a team environment.
Weekend Hours Required?
Occasional
Evening Hours Required?
Occasional
Duration Type
Regular
Work Week
Standard (M-F equal number of hours per day)
University Job Title
Clinical Research Coordinator 2
Worksite Address
789 Howard Avenue
New Haven, CT 06519
Work Location
Medical School Campus
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. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.
Searchable Job Family
Clinical
External Gateway Posting Date
24-Apr-2024
Total # of hours to be worked:
37.5
Position Focus:
The Clinical Research Coordinator (CRC) is responsible for participating in the day-to-day operations of assigned clinical research programs and/or studies conducted by Principal Investigators (PIs) in the Section of Pediatric Emergency Medicine at Yale School of Medicine. The CRC performs a variety of administrative and operational duties involved in the collection, compilation, documentation and review of clinical research data. Supports the achievement of research program and/or study objectives. Leads others in navigating the clinical research environment. Participates in a variety of departmental and/or divisional initiatives. Provides oversight to Research Assistants (RAs) enrolling patients in the pediatric emergency department at Yale New Haven Children’s Hospital or affiliated EDs, and enrolls patients and performs data collection for clinical research studies, when necessary. The CRC works within a multidisciplinary environment with colleagues both internally and externally in a cooperative manner exercising respectfulness and professionalism. The CRC will have direct patient contact and is responsible for managing and performing the clinical and operational aspects of moderately to highly complex study protocols. The CRC works under the general supervision of the Co-Research Directors and Section Chief of Pediatric Emergency Medicine.
Preferred Education, Experience and Skills:
Bachelor’s degree in a health-related discipline or related field is required; advanced research-related training preferred but not required (e.g., Masters of Public Health). Proven experience in clinical trials coordination is preferred but not required.
Posting Disclaimer
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.
EEO Statement:
University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.
Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).
Compensation Grade
Administration & Operations
Compensation Grade Profile
Supervisor; Senior Associate (23)
Bargaining Unit
None - Not included in the union (Yale Union Group)
Supervisory Organization
Pediatrics-Emergency Medicine
Time Type
Full time
Required Skill/Ability 1:
Knowledge of and ability to demonstrate proficiency in medical and clinical research related terminology.
Required Skill/Ability 2:
Knowledge of and ability to demonstrate proficiency in concepts of clinical research program, study design, and patient enrollment.
Required Skill/Ability 3:
Knowledge of and ability to recognize and employ professional guidelines and code of ethics related to the conduct of clinical research.
Required Skill/Ability 4:
Knowledge of and ability to maintain proficiency in best practices and regulatory rules for the conduct of clinical research.
Required Skill/Ability 5:
Skilled in developing and implementing quality assurance processes.
Note
Yale University is a tobacco-free campus
COVID-19 Vaccine Requirement
The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines
Wage Ranges
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Work Model
On-site
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