Senior Research Regulatory Coordinator RI Behav Trials Off

The Behavioral Trials Office (BTO) partners with investigators to provide efficient coordination and regulatory support for diverse behaviorally focused clinical research including behavioral intervention trials and observational studies. Our work spans multiple pediatric departments and developmental stages supporting innovative research that improves child health outcomes.

The Sr. Regulatory Coordinator plays a key role in this effort by providing regulatory oversight and support for multiple federally funded research addition this role contributes to the development and implementation of regulatory and compliance training initiatives within the BTO helping to ensure that research teams operate in accordance with institutional policies and federal regulations.

• 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.

Bachelors degree or equivalent experience in medical/science field.

(not specified)

CCRP certification preferred.

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.

Two years Clinical Research Experience required.

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

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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