Position Focus :
Within the Department of Neurology’s Clinical Research Office and reporting to the Research manager with a focus on movement disorders trials, the Clinical Research Coordinator (CRC) will lead efforts in the execution of research studies within the scope of the established study protocol(s) assigned.
These activities include, but are not limited to, study start up, patient screening, eligibility determination, registration and other protocol and subject milestones.
The CRC will also be the primary point of contact for the sponsor on all communications and management of all study documentation.
The CRC will have direct patient contact and will be responsible for managing multiple clinical research projects / trials and will serve as a back up to other clinical research coordinators within the clinical research team in Neurology.
The CRC will work collaboratively with postgraduate students. Some studies may require on call rotational support on weekends / after normal business hours.
Subjects will be recruited mainly in the New Haven campus but may be recruited from other Yale Neurology locations within the state of Connecticut.
Essential Duties
1. Compares protocols and sponsored projects to confirm consistency between funding proposals / awards and approved protocols.
2. Documents established congruency between funding proposals and approved protocols. 3. Facilitates and / or assists with resolution of any inconsistencies between funding proposals and approved protocols.
4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner.
5. Attends meetings and presents issues when necessary that were identified during congruency review. 6. Serves as a resource and provides technical assistance to investigators and their staff.
7. Provides analytical and technical support related to establishing and recording protocol / grant congruency, as needed.
8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements.
9. Develops, implements, and manages internal practices that ensure compliance with federal requirements. 10. May perform 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.
Required Skill / Ability 1 :
Excellent verbal and written communication skills, with demonstrated outstanding organizational and time management skills.
Ability to independently prioritize tasks with competing deadlines and priorities.
Required Skill / Ability 2 :
Demonstrated skill in careful attention to study requirements, regulatory compliance and accuracy in follow through. Ability to prepare and submit regulatory documents and maintenance documents for the life of the research study / trial.
Required Skill / Ability 3 :
Skilled in obtaining informed consent and related research subject interactions and requirements, including working with clinical providers to support the study.
Proven ability to track multiple occurrences and outcomes and document in a timely manner.
Required Skill / Ability 4 :
Demonstrated independence and management skills including critical thinking and problem solving to ensure effective study execution and compliance with sponsor policies.
Required Skill / Ability 5 :
Exemplary time and attendance. Ability to be flexible in schedule to attend to study needs and subject recruitment and work as a team with other clinical research coordinators.
Preferred Education, Experience and Skills :
Master’s degree in health or research related discipline, 2 years related work experience in a similar job family. Demonstrated ability to work with minimal supervision in a team atmosphere and receptiveness to direction and new processes.
Familiarity with neurological clinical research, especially with a focus on radiology. Proven experience in EPIC and OnCore systems and IRB submissions.
Preferred Licenses or Certifications :
Certified Clinical Research Professional (CCRP) or equivalent.
Weekend Hours Required?
Occasional
Evening Hours Required?
Occasional
Drug Screen
Health Screening
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 :
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.