Study Regulatory Coordinator (FOCD-Research) at DERMCARE MANAGEMENT LLC

Fountain Valley, California, United States -

Full Time

Start Date

Immediate

Expiry Date

31 Mar, 26

Salary

32.0

Posted On

31 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Detail Oriented, Organized, Teamwork, Task Prioritization, Stress Management, Problem Solving, Internet Proficiency, Microsoft Word, Microsoft Excel, Microsoft Outlook, Communication, Regulatory Knowledge, Clinical Trials, Research Compliance, Training, Documentation Management

Industry

Hospitals and Health Care

Description

Job Details Job Location: First OC Dermatology (FOCD) - Dr. Laquer - Fountain Valley - Fountain Valley, CA 92708 Salary Range: $30.00 - $32.00 Hourly 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. Essential Functions & 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 Skills & Abilities: 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 Personal Characteristics Ability to communicate effectively both orally and in writing Qualifications Qualifications & Experience Required: 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. Wage Range - $21.00/hr - $25.00/hr DOE

Responsibilities

The Study Regulatory Coordinator manages regulatory activities for clinical trials, ensuring compliance with regulations and institutional policies. They prepare and submit regulatory documents, oversee study start-up activities, and serve as a liaison between various stakeholders.