REGULATORY SPECIALIST - CRI

Full time
JR1000008856


Hours of Work :
8am-5pm
Days Of Week :
M-F
Work Shift :

Job Description :
Your Job:

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.

Methodist Health Systemis a highly revered, leading nonprofit healthcare organization in Dallas, Texas. Named one of the fastest-growing health systems in America by Modern Healthcare , Methodist includes 13 hospitals, either through ownership or affiliation. Our wholly owned and full-service hospitals include Methodist Dallas, Methodist Charlton, Methodist Mansfield, Methodist Midlothian, and Methodist Richardson Medical Centers; Methodist Richardson - Campus for Continuing Care; and, our newest, Methodist Southlake Medical Center. Our affiliated physician organization is Methodist Medical Group, which includes more than 50 healthcare clinics, two concierge medicine clinics, an urgent care clinic, and a virtual care platform known as MethodistNOW.At Methodist, we strive to have a diverse workforce that reflects the communities we serve - one that is welcoming of the skills and talents of all groups.Our reputation as an award-winning employer shows in the honors we've earned:

• Magnet® designations for Methodist Dallas, Methodist Charlton, Methodist Mansfield, and Methodist Richardson
• 150 Great Places to Work in Healthcare nine years in a row by Becker's Hospital Review
• Military Friendly® Employer, Silver Designation
• One of three Top Healthcare Diversity Organizations in the U.S., 2019
• Ranked No. 2 on DiversityInc's List of Top Hospitals and Health Systems in America, 2018

Our Care Commitments

• Take Care of Patients
• Take Care of Each Other
• Take Care of Ourselves
• Take Care of Methodist

Apply Here

PI213161725