Clinical Research Coach (Research Administration - Galveston) Certified CCRC or CCRP
Minimum Qualifications:
EDUCATION & EXPERIENCE
Bachelor’s degree and 7 years of experience with interventional clinical research or equivalent
LICENSES, REGISTRATIONS OR CERTIFICATIONS
Required: Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)
or similar certification through a recognized professional clinical research organization, or ability
to obtain professional certification within one year of employment.
Preferred Qualifications:
- Nursing or Medical Degree
- Clinical Research Monitor or Coordinator experience
- Experience with a Clinical Trial Management System (CTMS), electronic IRB platform and EMR
Job Summary:
The primary focus of the Clinical Research Coach is to provide mentorship, instruction and guidance to clinical research investigators, nurses, coordinators, and other study staff to promote high quality research and implement best practices. This position focuses on the operational aspects of compliant study conduct including recruitment, enrollment, consent process, study visit completion, source documentation, data collection and reporting.
Job Duties:
- Review and comprehend the scientific and operational aspects of clinical research protocols, including but not limited to the study purpose, schema, procedures, eligibility criteria, and study timelines.
- Work closely with assigned investigators and study teams throughout the entire study lifecycle to:
- Provide insight and feedback on IRB regulatory submission requirements, documents, and overall processes.
- Provide resources and best practices for developing source documents, protocol specific flowsheets, case report forms (CRFs), enrollment logs and deviation logs.
- Provide tools, processes, and training to promote regulatory and protocol compliance as it relates to subject recruitment, the consent process, subject eligibility, study visits, subject and regulatory documentation standards.
- Provide training and review of essential documents and creating/maintaining a regulatory binder.
- Accompany investigators and study staff for initial consent processes and study visits to provide support and feedback.
- Review initial study documentation to ensure it is attributable, legible, contemporaneous, original, accurate and complete.
- Prepare for monitoring and/or audits.
- Quickly identify when a Sponsor, Investigator or Institution should be alerted to concerns or issues.
- Collaborate with the Office of Institutional Compliance and the Office of Research Regulations and Compliance.
KNOWLEDGE/SKILLS/ABILITIES
• Working knowledge of 45CFR46 (Common Rule); 21CFR11, 50, 54, 56, 312, 600, 812; ICH E6
• Strong communication and collaborative skills
• Clear and concise writing skills
• Professionalism
Marginal or Periodic Functions:
• Adheres to internal controls and reporting structure.
• Performs related duties as required.
WORKING ENVIRONMENT/EQUIPMENT
• Standard hospital, clinical, and/or laboratory areas where clinical research may occur
• Standard office environment
• Standard office equipment. Microsoft Office Suite
Salary Range: Actual salary commensurate with experience or range if discussed and approved by hiring authority.
EQUAL EMPLOYMENT OPPORTUNITY:
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.
