Research Coordinator - Trauma

Hours of Work :

Days Of Week :

Work Shift :

Job Description :

Job Summary:
Under the direct supervision of the Clinical Research Institute (CRI) Director the Clinical Research Coordinator 1 (CRC1) will perform entry level coordination of Phase III and IV, investigator initiated trials (IITs), and retrospective analysis of clinical data. The CRC1 will support the mission, vision, values, and strategies of the Methodist Health System.

Education:
The CRC1 will posses
• A high school diploma (required)
• Bachelor’s degree (preferred)

License and/or Certification:
• Medical Assistant or Nurse’s Aid (required)
• CCRC or CCRP (preferred)
• Basic Life Support within 6 months of hire date (required)

Work experience and related skills:
• 1 year of experience in a medical or clinical setting (required)
• 1 year of experience in clinical research (preferred)
• Firm knowledge of computer skills (required)

Job Role/Duties:
• Review clinical research protocols to determine logistical components of trial management.
• Obtain relevant regulatory documents for clinical trials submission and management
• Maintain appropriate communications between sponsors, investigators, other research team members for clinical trials assigned.
• Prepare 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
• Screen, enroll, follow, and communicate clinical research trial subjects in accordance with appropriate research protocol guidelines
• Abstract appropriate clinical information for trial related source documents; electronic data capture platforms, and other case report form requirements.
• Perform appropriate clinical trial procedures (i.e. questionnaires, interviews, trial article accountability, laboratory/biomaterial handling and shipping, and scheduling
• Attend study specific training, investigator meetings as assigned, and MHS required training
• Assist investigators develop data collection tools in IITs
• Facilitate informed consent process for principal and sub-investigators
• Use MHS EMR to screen potential research participants in accordance with HIPAA regulations
• Identify and report 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
• Maintain appropriate information for continuing review notifications to the MHS IRB
• Liaison with sponsor representatives for qualification, initiation, monitoring, and close-out visits
• Respond to data clarification requests in a time sensitive fashion in accordance with MHS CRI standards and sponsor requirements
• Prepare and be available for any and all audits in relation to trials assigned
• Prepare study status reports for investigators and CRI Director
• Track submission and continuing review documents for completion and approval
• Other duties as assigned

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:

• Great Place to Work Certified 2026-2027

• Glassdoor’s Best Places to Work 2025 & 2026

• Glassdoor’s Best Places to Work in Healthcare, Biotech & Pharma 2026

• TIME’s Best Companies for Future Leaders 2025 & 2026

• Newsweek’s America’s Most Admired Workplaces 2026

• Glassdoor’s Best-Led Companies 2025

• Fortune Best Workplaces in Health Care 2025

• Military Friendly Gold Employer 2025

• Becker’s Hospital Review 150 Top Places to Work in Healthcare 2025

• Newsweek’s Americas Greatest Workplaces 2025