Regulatory Research Coordinator III (Trainer)

About the role

Support a portfolio of clinical research studies while helping to enhance the work of colleagues.

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.

Requirements

• 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.
• Education and Experience:
  • Bachelor's degree and the equivalent of five (5) years full-time experience in clinical research or health related field;
  • Associate's degree and the equivalent of seven (7) years of full-time experience in clinical research or health related field;
  • High School Diploma or High School Equivalency Diploma and nine (9) years of full-time experience in clinical research or health related field.
• Note: 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.

Qualifications

• 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.

Skills

• Excellent written and verbal communication skills.
• Strong organizational and time management skills.
• Ability to work independently and as part of a team.
• Proficiency in regulatory and compliance software.

Benefits

Comprehensive benefits package including a competitive salary range of $81,412 – $100,398, health insurance, retirement plans, paid time off, and professional development opportunities.

Pay

$81,412 – $100,398 per year

Schedule

Full-time, First Shift