REGULATORY SPECIALIST - CRI
Dallas, TX · On-site
... trial informed consent documents for Institutional Review Board (IRB) submission. • Maintain ... has a network of 12 hospitals (through ownership and affiliation) with nationally recognized ...
REGULATORY SPECIALIST - CRI
Dallas, TX · On-site
... trial informed consent documents for Institutional Review Board (IRB) submission. • Maintain ... has a network of 12 hospitals (through ownership and affiliation) with nationally recognized ...
Research Coordinator 1 - Department of Medicine, Division of Allergy & Infectious Diseases
Seattle, WA · On-site
$56 - $90/hr
Develop and maintain informed-consent materials and obtain appropriately completed informed-consent ... action. * Clincial Data and Safety Management - 20% Collect, review, evaluate, and enter study data ...
New
Research Coordinator 1 - Department of Medicine, Division of Allergy & Infectious Diseases
Seattle, WA · On-site
$56 - $90/hr
Develop and maintain informed-consent materials and obtain appropriately completed informed-consent ... action. * Clincial Data and Safety Management - 20% Collect, review, evaluate, and enter study data ...
New
Research Coordinator 1 - Department of Medicine, Division of Allergy & Infectious Diseases
Seattle, WA · On-site
Develop and maintain informed-consent materials and obtain appropriately completed informed-consent ... action. Clinical Data and Safety Management - 20% * Collect, review, evaluate, and enter study data ...
Research Coordinator 1 - Department of Medicine, Division of Allergy & Infectious Diseases
Seattle, WA · On-site
Develop and maintain informed-consent materials and obtain appropriately completed informed-consent ... action. Clinical Data and Safety Management - 20% * Collect, review, evaluate, and enter study data ...
Research Regulatory Coordinator
Urbana, IL · On-site
$25.81 - $43.10/hr
Performs Informed Consent review and modifies consent form/HIPAA language while working with ... preventive action plans as needed. Updates and maintains current protocol information on the ...
Research Regulatory Coordinator
Urbana, IL · On-site
$25.81 - $43.10/hr
Performs Informed Consent review and modifies consent form/HIPAA language while working with ... preventive action plans as needed. Updates and maintains current protocol information on the ...
Clinical Research Nurse
Winston Salem, NC · On-site
Review study protocols, schedules of events, informed consent forms, and study manuals to ensure ... action items. * Maintain essential regulatory documents and study files. * Collaborate with ...
Clinical Research Nurse
Winston Salem, NC · On-site
Review study protocols, schedules of events, informed consent forms, and study manuals to ensure ... action items. * Maintain essential regulatory documents and study files. * Collaborate with ...
Research Coordinator 1 - Department of Medicine, Division of Allergy & Infectious Diseases
Seattle, WA · On-site +1
Develop and maintain informed-consent materials and obtain appropriately completed informed-consent ... action. Clinical Data and Safety Management - 20% * Collect, review, evaluate, and enter study data ...
Research Coordinator 1 - Department of Medicine, Division of Allergy & Infectious Diseases
Seattle, WA · On-site +1
Develop and maintain informed-consent materials and obtain appropriately completed informed-consent ... action. Clinical Data and Safety Management - 20% * Collect, review, evaluate, and enter study data ...
Clinical Research Nurse
Travis Air Force Base, CA · On-site
$47 - $60/hr
Complete the necessary documents for approval, including the informed consent, recruitment ... Support and maintain quality corrective action/preventative action system. * Manage the CIF ...
Quick apply
Clinical Research Nurse
Travis Air Force Base, CA · On-site
$47 - $60/hr
Complete the necessary documents for approval, including the informed consent, recruitment ... Support and maintain quality corrective action/preventative action system. * Manage the CIF ...
Research Regulatory Coordinator
Urbana, IL · On-site
$24.50 - $32.50/hr
Performs Informed Consent review and modifies consent form/HIPAA language while working with ... preventive action plans as needed. Updates and maintains current protocol information on the ...
Research Regulatory Coordinator
Urbana, IL · On-site
$24.50 - $32.50/hr
Performs Informed Consent review and modifies consent form/HIPAA language while working with ... preventive action plans as needed. Updates and maintains current protocol information on the ...
Research Assistant
Bethlehem, PA · On-site
$19 - $26.25/hr
Prepares the informed consent and all IRB-related materials for review within established ... Lehigh Valley Health Network is an equal opportunity employer. In accordance with, and where ...
Research Assistant
Bethlehem, PA · On-site
$19 - $26.25/hr
Prepares the informed consent and all IRB-related materials for review within established ... Lehigh Valley Health Network is an equal opportunity employer. In accordance with, and where ...
Research Nurse Clinician (Livingston)
New Brunswick, NJ · On-site
$51.64/hr
Obtain informed consent for both therapeutic and non-therapeutic studies as assigned in accordance ... action up to and including termination.
Research Nurse Clinician (Livingston)
New Brunswick, NJ · On-site
$51.64/hr
Obtain informed consent for both therapeutic and non-therapeutic studies as assigned in accordance ... action up to and including termination.
Research Assistant
Bethlehem, PA · On-site
$19 - $26.25/hr
Prepares the informed consent and all IRB-related materials for review within established ... Lehigh Valley Health Network is an equal opportunity employer. In accordance with, and where ...
Research Assistant
Bethlehem, PA · On-site
$19 - $26.25/hr
Prepares the informed consent and all IRB-related materials for review within established ... Lehigh Valley Health Network is an equal opportunity employer. In accordance with, and where ...
Clinical Research Nurse
Travis Air Force Base, CA · On-site
$47 - $60/hr
Complete the necessary documents for approval, including the informed consent, recruitment ... Support and maintain quality corrective action/preventative action system. * Manage the CIF ...
Quick apply
Clinical Research Nurse
Travis Air Force Base, CA · On-site
$47 - $60/hr
Complete the necessary documents for approval, including the informed consent, recruitment ... Support and maintain quality corrective action/preventative action system. * Manage the CIF ...
OBGYN Physician
Bennington, VT · On-site
$250 - $350/hr
Obtain informed consent for treatment, diagnostic, and therapeutic procedures and studies ... affirmative action and equal opportunity employer. All qualified applicants will receive ...
OBGYN Physician
Bennington, VT · On-site
$250 - $350/hr
Obtain informed consent for treatment, diagnostic, and therapeutic procedures and studies ... affirmative action and equal opportunity employer. All qualified applicants will receive ...
Open Rank Clinical Research Coordinator (Entry - Senior)
Aurora, CO · On-site
$24.75 - $32.75/hr
Perform informed consent process or ensures that the informed consent process has occurred, is ... Minimum Qualifications: Entry Level: * Bachelor's degree in any field. Intermediate Level:
Open Rank Clinical Research Coordinator (Entry - Senior)
Aurora, CO · On-site
$24.75 - $32.75/hr
Perform informed consent process or ensures that the informed consent process has occurred, is ... Minimum Qualifications: Entry Level: * Bachelor's degree in any field. Intermediate Level:
Clinical Research Nurse
Hampton, VA · On-site
$47K - $128K/yr
Participating in the informed consent process and enrolling patients on protocol * 80% of the job will be computer based, and direct patient care is limited in a non-RN Clinical Research Coordinator ...
Clinical Research Nurse
Hampton, VA · On-site
$47K - $128K/yr
Participating in the informed consent process and enrolling patients on protocol * 80% of the job will be computer based, and direct patient care is limited in a non-RN Clinical Research Coordinator ...
Perform informed consent process or ensures that the informed consent process has occurred, is ... Minimum Qualifications: Entry Level: * Bachelor's degree in any field. Intermediate Level:
Perform informed consent process or ensures that the informed consent process has occurred, is ... Minimum Qualifications: Entry Level: * Bachelor's degree in any field. Intermediate Level:
Perform informed consent process or ensures that the informed consent process has occurred, is ... Minimum Qualifications: Entry Level: * Bachelor's degree in any field. Intermediate Level:
Perform informed consent process or ensures that the informed consent process has occurred, is ... Minimum Qualifications: Entry Level: * Bachelor's degree in any field. Intermediate Level:
Clinical Research Nurse/Coordinator
Norfolk, VA · On-site
$47K - $128K/yr
Participating in the informed consent process and enrolling patients on protocol * 80% of the job will be computer based, and direct patient care is limited in a non-RN Clinical Research Coordinator ...
Clinical Research Nurse/Coordinator
Norfolk, VA · On-site
$47K - $128K/yr
Participating in the informed consent process and enrolling patients on protocol * 80% of the job will be computer based, and direct patient care is limited in a non-RN Clinical Research Coordinator ...
... with informed consent for medication trials • Serve as a liaison with schools, family members ... network with extensive psychiatric treatment, research, and academic programs • Includes ...
... with informed consent for medication trials • Serve as a liaison with schools, family members ... network with extensive psychiatric treatment, research, and academic programs • Includes ...
Open Rank Clinical Research Coordinator (Entry - Senior)
Aurora, CO · On-site
$24.75 - $32.75/hr
Perform informed consent process or ensures that the informed consent process has occurred, is ... Minimum Qualifications: Entry Level: * Bachelor's degree in any field. Intermediate Level:
Open Rank Clinical Research Coordinator (Entry - Senior)
Aurora, CO · On-site
$24.75 - $32.75/hr
Perform informed consent process or ensures that the informed consent process has occurred, is ... Minimum Qualifications: Entry Level: * Bachelor's degree in any field. Intermediate Level:
Full-time
Re-posted 26 days ago
Job description
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 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:
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 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