Career opportunities at Methodist Health System
REGULATORY SPECIALIST - CRI
- Job Title
- REGULATORY SPECIALIST - CRI
- Job ID
- Dallas, TX 75203
- Other Location
REGULATORY SPECIALIST - CRI
CLINICAL RESEARCH INSTITUTE
METHODIST HEALTH SYSTEM
DALLAS, TX, 75265-5999
Full-time · Day · 08:00-17:00
Req # 20058925
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.