Study Regulatory Coordinator (FOCD-Research)

DERMCARE MANAGEMENT LLC•Fountain Valley, CA

2d•$30 - $32

About The Position

The Study Regulatory Coordinator leads, coordinates and oversees regulatory processes across multiple studies of different therapeutic areas and phases, in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes independently. Studies may be large, nationwide, or moderately complex involving multiple sites and/or assessments/interventions.

Requirements

Ability to be detail oriented, organized, perform basic computer functions, and work effectively in a team environment
Must be able to prioritize tasks; work well under stress, meet aggressive timelines, and problem solve to quickly and tactfully manage challenging situations concerning customer groups
Must be willing to work flexible hours if needed
Must demonstrate intermediate competency in the use of the Internet and the following Microsoft applications: Word, Excel, Outlook
Associate Degree/Bachelor’s Degree: Bachelor’s or Associate degree in a related field. An applicable degree may be nursing, life sciences, business administration, or health care administration or research administration. (Required)
1-2 years: Minimum of one (1) yeas of clinical research experience required. Prior regulatory experience preferred.

Responsibilities

Manages regulatory activities for all stages of clinical trials for assigned department (s). Prepares and submits regulatory documents to Sponsor and IRB and works with clinical research team to ensure submission documents are up-to-date.
Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. Provides guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies.
Completes industry registrations and study feasibility questionnaires including receipt, tracking and correspondence with Sponsor/CRO/ARO
Prepare and submit start-up regulatory packets to Sponsor and IRB
Oversee study start-up activities to including reporting and communicating with stakeholders on a regular basis
Serve as a liaison to Sponsors/CRO/IRB/Investigators assuring continuity of service and problem resolution
Monitor approval status of open studies by completing timely reviews
Maintain master files of all regulatory-related documents
Assist in submission of Investigational New Drug (IND) applications including amendments and reporting
Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits