Regulatory Strategist for Clinical Trials

Methodist Health System; Texas; On-site; USD 70,000 - 95,000; Full time

Job summary

Methodist Health System is seeking a Regulatory Specialist to oversee regulatory components of clinical research trials, including Phase II/IV, IITs, and retrospective analyses. The role supports MHS’s mission and strategies, with emphasis on compliance, documentation, and cross-functional collaboration.

Requirements include a Bachelor’s degree (Master’s preferred), CCRP/CCRC and GCP qualifications preferred, and at least one year of clinical, research, and regulatory affairs experience.

Qualifications

• 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.

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 regulatory documents for trials submission and management.
• Maintain communications between sponsors, investigators, and other research team members.
• Assist in the development of clinical trial documents for signature of principal investigator and IRB approval.
• Create and/or adapt informed consent documents for IRB submission.
• Maintain regulatory documents in line with ICH and GCP guidelines.
• Attend study specific training and required trainings.
• Facilitate informed consent process for investigators.
• Assist coordinators in identification and reporting of adverse events per FDA and IRB guidelines.
• Prepare and submit amendments to protocols and informed consent documents.

Skills

Regulatory affairs

Communication

Leadership

Detail oriented

Problem solving

Team collaboration

Education

Bachelor’s degree

Master’s degree preferred

CCRC/CCRP

GCP certification

Tools

Microsoft Office

Job description

Methodist Health System is seeking a Regulatory Specialist to oversee regulatory components of clinical research trials, including Phase II/IV, IITs, and retrospective analyses. The role supports MHS’s mission and strategies, with emphasis on compliance, documentation, and cross-functional collaboration.

Requirements include a Bachelor’s degree (Master’s preferred), CCRP/CCRC and GCP qualifications preferred, and at least one year of clinical, research, and regulatory affairs experience.