Regulatory Research Coordinator III (Trainer)
About The Position
In this role, you will support a portfolio of clinical research studies while helping elevate the work of those around you. Lead and support regulatory activities for clinical trials, from startup through closeout. Prepare and submit study documents such as new protocols, amendments, and continuing reviews. Ensure compliance with FDA regulations and Good Clinical Practice (GCP) standards. Partner with investigators, sponsors, and internal teams to keep studies on track. Review regulatory documentation for accuracy, completeness, and timeliness. Mentor and train team members, sharing best practices and building team capability. Identify opportunities to improve processes and drive more efficient, compliant ways of working. Act as a change champion, helping teams adopt new tools and approaches.
Requirements
- Strong knowledge of clinical research regulations and compliance standards (FDA, GCP)
- Experience managing regulatory aspects of clinical trials or research studies
- Confidence in training, presenting, and mentoring others
- A collaborative mindset with strong communication skills
- Ability to manage multiple studies and priorities with attention to detail
- A proactive approach to problem-solving and process improvement
- Comfort leading change and influencing others in a positive way
- Bachelor's degree and the equivalent of five (5) years full-time experience in clinical research or health related field; or
- Associate's degree and the equivalent of seven (7) years of full-time experience in clinical research or health related field; or
- High School Diploma or High School Equivalency Diploma and nine (9) years of full-time experience in clinical research or health related field.
- Current certification by the Association of Clinical Research Professionals (ACRP); or
- Current certification by the Society of Clinical Research Associates (SOCRA); or
- Other comparable research-related certifications recognized by Roswell Park Comprehensive Cancer Center as appropriate for this title.
- Incumbents must obtain and maintain certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) or from other comparable research-related certifications recognized by Roswell Park Comprehensive Cancer Center as appropriate for this title within one (1) year of appointment as a condition of continued employment.
- Required degrees must have been granted by an accredited school, college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices.
Responsibilities
- Lead and support regulatory activities for clinical trials, from startup through closeout
- Prepare and submit study documents such as new protocols, amendments, and continuing reviews
- Ensure compliance with FDA regulations and Good Clinical Practice (GCP) standards
- Partner with investigators, sponsors, and internal teams to keep studies on track
- Review regulatory documentation for accuracy, completeness, and timeliness
- Mentor and train team members, sharing best practices and building team capability
- Identify opportunities to improve processes and drive more efficient, compliant ways of working
- Act as a change champion, helping teams adopt new tools and approaches
Benefits
- A competitive salary range of $66,021 – $83,134 plus a full benefits package that supports your health, wellbeing, and future
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
