Hours of Work :8am-5pmDays Of Week :M-FWork 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 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:
Magnet® designations for Methodist Dallas, Methodist Charlton, Methodist Mansfield, and Methodist Richardson Medical Centers
150 Top Places to Work in Healthcare by Becker’s Hospital Review , 2023
Top 10 Military Friendly® Employer, Gold Designation, 2023
Top 10 Military Spouse Friendly® Employer, 2023
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:
Magnet® designations for Methodist Dallas, Methodist Charlton, Methodist Mansfield, and Methodist Richardson Medical Centers
150 Top Places to Work in Healthcare by Becker’s Hospital Review , 2023
Top 10 Military Friendly® Employer, Gold Designation, 2023
Top 10 Military Spouse Friendly® Employer, 2023
Equal Opportunity EmployerIt is the policy of Methodist Health System (MHS) to select, develop, and promote employees based on individual ability and job performance. It has been, and will continue to be, the policy of MHS to provide equal employment opportunity to all people in all aspects of employer-employee relations without discrimination because of race, color, religion, national origin, age, sex, sexual orientation, gender expression, disability, marital status, genetic information or ancestry. This policy affects decisions including, but not limited to, an employee’s compensation, benefits, terms and conditions of employment, opportunities for promotion, training, development, transfer all other privileges of employment. MHS is committed to maintain a working environment free of intimidation, workplace discrimination and harassment. Retaliation or attempted retaliatory behavior that occurs as a result of an employee’s exercise of their rights under this policy or any other statutorily protected right is strictly prohibited and will be grounds for disciplinary action.