"Clinical Research Coordinator- Epilepsy"

Neurology - Clinical Research

89843BR

University Job Title

Coordinator 4, Research Support

Bargaining Unit

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

Time Type

Full time

Duration Type

Fixed

If Fixed Duration, Period

5 years from date of hire

If Fixed Duration, is continuation possible?

Yes

Other Fixed Duration Date

30-Sep-2029

Compensation Grade

Administration & Operations

Compensation Grade Profile

Supervisor; Senior Associate (23)

Wage Ranges

Click here to see our Wage Ranges

Searchable Job Family

Clinical, Research Res Support, Research/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

15 York Street

New Haven, CT 06510

Work Model

Hybrid

Position Focus:

* Please note that while some tasks can be done remotely, a significant portion of this position requires in-person work.*

Within the Department of Neurology’s Clinical Research Office and reporting to the Research manager, the Clinical Research Coordinator (CRC) will lead efforts in an NIH funded grant studying seizure forecasting through acquisition and analysis of saliva samples. These activities include, but are not limited to, coordination with staff in the epilepsy monitoring unit and clinical team, study start up, patient screening, eligibility determination, obtaining consent from the patient, registration and other protocol and subject milestones. The CRC will have direct patient contact and will be responsible for managing the trial (including but not limited to maintaining database of information such as pre-screened, screened and enrolled patients, patients who withdraw from the study, and data as the time of sample collections and seizures). Some activities may require on call rotational support on weekends/after normal business hours. Subjects will be recruited mainly in Connecticut. The CRC will also be responsible for interacting with and supporting sample acquisition at a second study site at the University of California San Francisco. The CRC will also be the primary point of contact for the sponsor on all communications and management of all study documentation. 

Essential Duties

1. Interact directly with research subjects and research staff to support the study, including recruitment, consent, education, sample collection, sample transportation, sample storage, monitoring, compliance, and retention.

2. Educate clinical staff on sample collection, meet with them regularly, and serve as their main contact for questions. Actively participate in sample collection, as needed.

3. Coordinate with couriers and research subjects to ensure timely shipment of materials (e.g., sample collection vials, wearables, freezers), training on at-home freezer and wearable use, proper sample storage, and safe transportation of samples to Yale.

4. Visit study participant’s homes to set up freezers and provide training on proper sample collection and storage when necessary.

5. Ensure sample collection freezers and wearables are functioning, sanitized before dispatch, and safely transported.

6. Monitor and log freezer temperatures for sample integrity. 

7. Maintain accurate records of study participants, collected samples, and metadata related to the project.

8. Assist with amendments, renewals, and oversight of the human subjects research protocol.

9. Monitor federal and state regulations for new guidance, updates, or policies. Maintain thorough knowledge of these requirements to determine necessary actions and ensure University compliance with human subjects research and reporting requirements.

10. Develop, implement, and manage standard operating procedures that ensure compliance with state and federal requirements related to the project.

11. May perform other duties as assigned.

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. Experience with the IRB and knowledge about IRB processes (study amendments, protocol updates).

Required Skill/Ability 3:

Skilled in obtaining informed consent & related research subject interactions/requirements working with clinical providers to support the study. Ability to track multiple occurrences & outcomes & document in a timely manner. Professional patient bedside manner, team player, willing and capable to acquire new skills critical for the maintenance of the study.

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 and 2 years of 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 strongly preferred. 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

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.

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