"Clinical Research Coordinator- ARIA"

Overview

Under the direction of the research manager and PI, the CRC leads the research team in the execution of trials within the scope of the established study protocol. Adheres to all human subject's regulations as defined by Yale University and the federal government that pertain to research studies. Proven ability to coordinate research activities as well as work with a team to develop action items and other means to keep projects moving along according to timeline with demonstrated ability to report on the status of project deliverables and draft and submit project updates to Yale team and potential study sponsor.

Required Skills and Abilities

1. Proven ability to lead a research team in the execution of trials within the scope of the established study protocol and easily adapts to research in multiple disease areas; Bilingual, Spanish, and English.
2. Demonstrated skill in meticulous attention to study requirements, regulatory constraints, and accurate follow-through. Ability to prepare and submit regulatory documents and maintenance requirements for the life of the trial(s).
3. Thoroughly skilled in obtaining informed consent and related research subject interactions and requirements. Proven ability to track multiple occurrences and outcomes and document the same in a timely manner. Exceptional organizational skills.
4. Demonstrated independence and management skills among multiple study sites. Demonstrated ownership of communication requirements necessary for effective oversight and conduct of human clinical research utilizing multiple electronic data capture systems.
5. Demonstrated ability and skill for data management and timely execution into multiple databases. Demonstrated ability and skill for specimen collection, laboratory processing, and vital sign execution.

Preferred Education, Experience and Skills

Bachelor's in health or research-related discipline and 3 years of related work experience in a similar job family. Ability to work with minimal supervision in a team atmosphere and receptiveness to direction regardless of disease area. Working knowledge of EDC systems and adoption of new data management systems. EKG capabilities and phlebotomy skills are strongly preferred, Bilingual.

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

$66,000.00 - $101,325.00