REGULATORY SPECIALIST - CRI

Job Description The Regulatory Specialist will perform expertise in the regulatory component of all clinical research trials, including Phase II and IV clinical trials, investigator‑initiated trials (IITs), and retrospective analysis of clinical data. The role supports the mission, vision, values, and strategies of Methodist Health System. 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 Responsibilities Communicate clearly and openly Build relationships to promote a collaborative environment Be accountable for performance Always look for ways to improve the patient experience Take initiative for 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, and 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 submission Maintain regulatory documents in accordance with ICH and GCP guidelines Attend study‑specific training, investigator meetings, and required MHS training Facilitate informed consent process for principal and sub‑investigators Assist clinical research coordinators in identification and reporting of appropriate adverse events in accordance with FDA, sponsor protocol, and IRB regulations and guidelines Prepare and submit amendments to protocols and informed consent documents as required Work Hours 8 am – 5 pm, Monday through Friday #J-18808-Ljbffr Methodist Health System