Overview:

Job Description Summary:

Coordinates the regulatory and compliance process of all clinical research conducted in the NCH/RI system. Oversees the preparation and submission of regulatory and compliance documents to study sponsors and assists with quality improvement initiatives. Coordinates submissions of human subjects research project to the Institutional Review Board (IRB) andof Investigational New Drug Applications (IND’s) to the U.S. Food and Drug Administration (FDA).

Job Description:

Essential Functions:

Reviews study protocols in order to write consent/assent documents and develop the initial IRB submission; submits protocol amendments; responds to contingencies and obtains final approval of documents from sponsor and IRB, on behalf of principal investigator.
Serves as liaison between study sponsors and the research team (IRB, research staff and Principal Investigator) regarding regulatory matters in the IRB submission and approval process.
Responsible for the preparation, submission and maintenance of documents and processes related to investigator-initiated drug/device projects. Serves as liaison with federal agencies as needed.
Oversees the creation and maintenance of regulatory documents and the study administrative binder required for the clinical research project.
Maintains current knowledge of federal research regulations by reviewing current publications and attending conferences. Advises management of regulation changes and projected impact within Clinical Research Services and the institution.
Primary resource to provide guidance to investigators and research staff on federal regulations, good clinical practices and IRB policies and systems. Identifies protocol content which may conflict with federal and/or local requirements or practice.
Assists with quality improvement audits, including the administrative binder, subject research records, case report forms and other study documents.
Responsible for data required for CCTS annual report and other metrics as required.

Education Requirement:

Bachelor’s degree or equivalent experience in medical/science field.

Licensure Requirement:

(not specified)

Certifications:

CCRP certification preferred.

Skills:

Knowledge of medical terminology and diseases, preferred.

Excellent computer skills.

Ability to multi-task with strong organizational and prioritization skills.

Strong attention to detail.

Customer focused personality.

Working knowledge of IRB and regulatory processes and systems.

Current knowledge of Federal regulations (FDA, GCP, NIH, DHHS, ICH GCP), and study protocols.

Experience:

Two years Clinical Research Experience, required.

Physical Requirements:

OCCASIONALLY: Bend/twist, Driving motor vehicles (work required) *additional testing may be required, Reaching above shoulder, Squat/kneel

FREQUENTLY: Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Sitting, Standing, Walking

CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing – Far/near

Additional Physical Requirements performed but not listed above:

(not specified)

"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"

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Senior Research Regulatory Coordinator - RI Gene Ther