Clinical Research Regulatory Supervisor

Position Title: Clinical Research Regulatory Supervisor

Duration: 06 Months with possibility of extension

Location: 1 Hoag Dr, Hoag Newport Beach. CA 92663

Shift hours: 8:30am-4pm M-F

Position Summary

The Clinical Research Regulatory Supervisor assists in overseeing clinical research regulatory operational activities. Is responsible for conducting clinical research to industry standards and best practices.

Assists with ensuring proposed projects meet the mission and vision of Company and all Clinical Research stakeholders.

Assists the clinical research teams (physicians, nurses, etc.) by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout a clinical research studys duration for studies involving human participants.

Ensures all research studies are compliant with regulations and maintains accurate, up-to-date, regulatory files.

Is the central resource for staff.

Manage the day-to-day clinical research regulatory operations ensuring regulatory responsibilities are completed correctly and completely.

Interact daily with team to ensure Study compliance. Oversees the process of informed consents to include institutional language.

Works with legal/sponsors to ensure CTA language is consistent with consent.

Primary Duties And Responsibilities

Designs, implements, and manages a system for organizing, planning workflow related to all research

regulatory study activities including developing organizational forms and tools to conduct the study

accurately and in compliance with Good Clinical Practice, to facilitate study completion and compliance. Is

up to date on current federal, state, and local regulations and communicates changes to study team. Works

closely with Director Clinical Research Finance & Regulatory.

Provides institutional authorization for new submissions with IRB. Tracks each protocol through the

IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to

decrease delay in the approval process.

Registers maintains clinical trials on clinicaltrials.gov website for applicable studies and works with trials on clinicaltrials.gov website for applicable studies and works with sponsors to include company.

Maintains and updates the study management portion of the Customers clinical trial management system.

Maintains Institutions Federal Wide Assurance to ensure company remains current and compliant. Assists in the

development, writing, and maintenance of SOPs including work instructions, forms, and templates. Other

duties as assigned.

Education And Experience

High School Graduate or equivalent required

Bachelors Degree or Five plus (5+) years experience with Clinical Research.

Excellent Communication And Organizational Skills Required.

Understands and keeps current with FDA and Medicare regulations and/or third-party insurance guidelines

applicable to clinical trials required.

Is knowledgeable of Clinical Research study protocols and internal SOPs required.

Preferred Skills & Experience

Excellent communication and organizational skills required.

Understands and keeps current with FDA and Medicare regulations and/or third-party insurance guidelines applicable to clinical trials required.

Is knowledgeable of Clinical Research study protocols and internal SOPs required.