Regulatory Specialist

Methodist Health System•Dallas, TX

About The Position

The Regulatory Specialist performs regulatory work for clinical research trials, including Phase II and IV clinical trials, investigator-initiated trials (IITs), and retrospective analyses of clinical data. The role supports the mission, vision, values, and strategies of Methodist Health System. The specialist reviews protocols, coordinates regulatory documentation and submissions, maintains communications among sponsors, investigators, and research teams, and supports informed consent and adverse-event reporting processes. Regulatory documents must be maintained in accordance with International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.

Requirements

Bachelor's degree required.
One year of experience in a medical or clinical setting required.
One year of experience in clinical research required.
One year of experience in research regulatory affairs required.
Strong proficiency using Microsoft Office products.
Superior oral and written communication skills.
Strong process orientation.
Detail-oriented, logical, and methodical approach to problem solving.
Ability to provide vision and leadership.

Nice To Haves

Master’s degree preferred.
CCRC or CCRP preferred.
GCP certification preferred.

Responsibilities

Communicate clearly and openly.
Build relationships to promote a collaborative environment.
Be accountable for performance.
Look for ways to improve the patient experience.
Take initiative for professional growth.
Be engaged and eager to build a winning team.
Review clinical research protocols to determine logistical components of regulatory requirements.
Obtain and facilitate tracking of relevant regulatory documents for clinical trial submission and management.
Maintain appropriate communications among sponsors, investigators, and other research team members for assigned clinical trials.
Assist in developing clinical trial documents for principal investigator signature and IRB approval.
Create and/or adapt clinical trial informed consent documents for Institutional Review Board (IRB) submission.
Maintain regulatory documents in accordance with International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.
Attend study-specific training, assigned investigator meetings, and required Methodist Health System training.
Facilitate the informed consent process for principal and sub-investigators.
Assist clinical research coordinators in identifying and reporting appropriate adverse events in accordance with FDA, sponsor protocol, and IRB regulations and guidelines.
Prepare and submit protocol and informed consent document amendments as required.