Clinical Trials Regulatory Specialist

Methodist Health System; Dallas (TX); On-site; USD 65,000 - 95,000; Full time

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

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.