
R20841 Regulatory Research Coordinator III (Trainer)
Roswell Park Comprehensive Cancer Center
BUFFALO, NYJob$81–100K/yrSeen todaySeen in employer's feed today
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Job overview
The Regulatory Research Coordinator III (Trainer) supports a portfolio of clinical research studies and leads regulatory activities for clinical trials from startup through closeout. The role prepares and submits study documents, ensures compliance with FDA regulations and Good Clinical Practice standards, and partners with investigators, sponsors, and internal teams. It also mentors and trains team members, improves processes, and helps teams adopt new tools and approaches.
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Full job description
What Youll Do 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 reviewsEnsure compliance with FDA regulations and Good Clinical Practice (GCP) standardsPartner with investigators, sponsors, and internal teams to keep studies on trackReview regulatory documentation for accuracy, completeness, and timelinessMentor and train team members, sharing best practices and building team capabilityIdentify opportunities to improve processes and drive more efficient, compliant ways of workingAct as a change champion, helping teams adopt new tools and approaches ## What Youll Bring Were looking for someone who combines regulatory expertise with a passion for teaching and continuous improvement. Strong knowledge of clinical research regulations and compliance standards (FDA, GCP)Experience managing regulatory aspects of clinical trials or research studiesConfidence in training, presenting, and mentoring othersA collaborative mindset with strong communication skillsAbility to manage multiple studies and priorities with attention to detailA proactive approach to problem-solving and process improvementComfort leading change and influencing others in a positive way ## Why Youll Love Working Here At Roswell Park, youll find more than a jobyoull find purpose, collaboration, and opportunity. Mission-driven work: Be part of a nationally recognized cancer center dedicated to cutting-edge research and compassionate careCollaborative environment: Work alongside passionate experts who support and learn from one anotherGrowth and development: Opportunities to expand your skills, take on leadership, and grow your careerInnovation-focused culture: Your ideas to improve processes and patient outcomes are valued Comprehensive benefits: A competitive salary range of $81,412 $100,398 plus a full benefits package that supports your health, wellbeing, and future. Qualifications:Required Education and Experience Certification Requirement1. Current certification by the Association of Clinical Research Professionals (ACRP); or2. Current certification by the Society of Clinical Research Associates (SOCRA); or3. Other comparable research-related certifications recognized by Roswell Park Comprehensive Cancer Center as appropriate for this title. Education and Experience1. Bachelor's degree and the equivalent of five (5) years full-time experience in clinical research or health related field; or2. Associate's degree and the equivalent of seven (7) years of full-time experience in clinical research or health related field; or3. High School Diploma or High School Equivalency Diploma and nine (9) years of full-time experience in clinical research or health related field. NOTE:1. 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.2. 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.
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