Clinical Research Coordinator 2

Pediatrics – Endocrinology

86748BR

University Job Title

Clinical Research Coordinator 2

Bargaining Unit

None – Not included in the union (Yale Union Group)

Compensation Grade

Administration & Operations

Compensation Grade Profile

Supervisor; Senior Associate (23)

Wage Ranges

Click here to see our Wage Ranges

Searchable Job Family

Research Res Support

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

789 Howard Avenue
New Haven, CT 06519

Position Focus:

Provide research services to patients participating in clinical trials within Pediatric Endocrinology. The main trial is an NIH drug study. The position will schedule appointments to screen and if eligible, will enroll the patient in the study. It is a 9-month study with regular monthly in person visits for the first 6 months. Position is responsible for protocol amendments and managing regulatory binder. The position will also meet with the statistician preparing DSMB, and manage monitor visits.

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. Experience must indicate the ability to work with minimal supervision in a team environment.

Required Skill/Ability 1:

Ability to use EMR, RedCap, and EDC.

Preferred Education, Experience and Skills:

BS in health-related discipline, but MS preferred. At least 2 years of research experience or education equivalent. Knowledge of Good Clinical Practices (GCP). Must be highly motivated and have ability to work with minimal supervision in a team environment. Prefer fluency in Spanish, but not required.

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

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.

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

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).

Note

Yale University is a tobacco-free campus