"Clinical Research Coordinator - Neurosurgery"

Overview

This will be a hybrid position, with a minimum of three days onsite

Within the Department of Neurosurgery’s Clinical Research Office, 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 on all communications and management of all study documentation. The CRC will have direct patient contact and will be responsible for managing all clinical trials. Some studies may require on call rotational support on weekends/after normal business hours. Subjects will be recruited in the New Haven location but may be recruited from other Yale Neurosurgery locations within the state of Connecticut.

Compares protocols and sponsored projects to confirm consistency between funding proposal/award and approved protocol. Documents established congruency between funding proposal and approved protocol. Facilitates and/or assists with resolution of any inconsistencies between funding proposal and approved protocol. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. Attends meetings and presents issues, when necessary, that were identified during congruency review. Serves as a resource and provides technical assistance to investigators and their staff. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed. 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. Develops, implements, and manages internal practices that ensure compliance with federal requirements. May perform other duties as assigned.

Required Skills and Abilities

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.
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.
3. Demonstrated experience coordinating clinical trials. Demonstrated experience 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.
4. Demonstrated independence and management skills including critical thinking and problem solving to ensure effective study execution and compliance with sponsor policies.
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

1. Master’s degree in health or research related discipline and two years of related work experience in a similar job family.
2. Strongly prefer candidates with a demonstrated ability to work with minimal supervision in a team atmosphere and receptiveness to direction and new processes.
3. Familiarity with neurological clinical research strongly preferred.
4. Proven experience in EPIC and OnCore systems and IRB submissions.

Preferred Licenses or Certifications

1. Certified Clinical Research Professional (CCRP) or equivalent.

Principal Responsibilities

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.

Salary Range

$65,000.00 - $101,000.00