Regulatory Specialist

Methodist Health System

Dallas (TX)

On-site

USD 65,000 - 95,000

Full time

8 days ago

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Job summary

Methodist Health System in Dallas, TX seeks a Regulatory Specialist to lead regulatory activities for Phase II/IV trials, IITs, and retrospective analyses. You will ensure compliance with ICH/GCP, prepare regulatory documents, and coordinate with sponsors, investigators, and the IRB.

Requirements include a bachelor’s degree and 1 year of clinical/research regulatory experience; CCRP/CCRC and GCP certifications are preferred. This is an on-site role within a faith-based healthcare network.

Qualifications

Bachelor’s degree required; Master’s degree preferred.
CCRC or CCRP certification preferred.
GCP certification preferred.
1 year of experience in a medical or clinical setting required.
1 year of experience in clinical research required.
1 year of experience in research regulatory affairs required.

Responsibilities

Communicate clearly and openly.
Build relationships to promote a collaborative environment.
Be accountable for your performance.
Always look for ways to improve the patient experience.
Take initiative for your professional growth.
Be engaged and eager to build a winning team.
Review clinical research protocols to determine regulatory requirements.
Obtain and facilitate tracking of relevant regulatory documents for trials submission and management.
Maintain communications between sponsors, investigators, and research team members.
Assist in developing clinical trial documents for signature by the principal investigator and IRB approval.
Create/adapt informed consent documents for IRB submission.
Maintain regulatory documents per ICH and GCP guidelines.
Attend study trainings and required trainings.
Facilitate informed consent process for investigators.
Assist coordinators in identifying/reporting adverse events per FDA, protocol, IRB.
Prepare and submit protocol amendments and consent amendments.

Skills

Strong communication

Detail oriented

Problem solving

Leadership

Education

Bachelor’s degree

Master’s degree preferred

Tools

Microsoft Office

Job description

Hours of Work :

8am-5pm

Days Of Week :

M-F

Job Shift :

Job Description :

Your Job:

The Regulatory Specialist will perform expertise in the regulatory component of all clinical research trials to include, but not limited to; Phase II and IV clinical, investigator initiated trials (IITs), and retrospective analysis of clinical data. The Regulatory Specialist will support the mission, vision, values, and strategies of the Methodist Health System.

Your Job Requirements:

Bachelor’s degree required; Master’s degree preferred
CCRC or CCRP (preferred)
GCP certification (preferred)
1 year of experience in a medical or clinical setting (required)
1 year of experience in clinical research (required)
1 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 methodological approach to problem solving
Ability to provide vision and leadership.

Your Job Responsibilities:

Communicate clearly and openly
Build relationships to promote a collaborative environment
Be accountable for your performance
Always look for ways to improve the patient experience
Take initiative for your 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 trials submission and management.
Maintain appropriate communications between sponsors, investigators, other research team members for clinical trials assigned.
Assist in the development of clinical trial documents for signature of principal investigator and approval by the IRB.
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, investigator meetings as assigned, and MHS required training.
Facilitate informed consent process for principal and sub-investigators.
Assist clinical research coordinators in the identification and reporting of appropriate adverse events in accordance with Food and Drug Administration, sponsor protocol, and IRB regulations and guidelines.
Prepare and submit amendments to protocols and informed consent documents as required.

Methodist Health System is a faith-based organization with a mission to improve and save lives through compassionate, quality healthcare. For nearly a century, Dallas-based Methodist Health System has been a trusted choice for health and wellness. Named one of the fastest-growing health systems in America by Modern Healthcare, Methodist has a network of 12 hospitals (through ownership and affiliation) with nationally recognized medical services, such as a Level I Trauma Center, multi-organ transplantation, Level III Neonatal Intensive Care, neurosurgery, robotic surgical programs, oncology, gastroenterology, and orthopedics, among others. Methodist has more than two dozen clinics located throughout the region, renowned teaching programs, innovative research, and a strong commitment to the community. Our reputation as an award-winning employer shows in the distinctions we’ve earned: