Clinical Research Regulatory Specialist

This is a full-time staff position with an annual compensation of $75,968.95.

About the role

We are seeking a clinical research regulatory specialist to assist with the development and management of an NIH RF1-grant funded clinical trial in which individuals with stroke will be enrolled and participate in study activities over the course of one year.

Responsibilities

• Manage and support day-to-day clinical research operations, including participant recruitment, scheduling, data collection, study visit coordination, data entry and verification, staff training, and communications.
• Oversee laboratory resource utilization by managing supply procurement, inventory control, and general clinical laboratory safety.
• Maintain complete and accurate clinical research records, study files, training records, and laboratory documentation, ensuring all activities comply with federal and institutional guidelines.

Requirements

• Bachelor’s degree (minimum education requirement).
• Combined experience/education may substitute for minimum education.
• 2 years of experience (minimum). Combined experience/education may substitute for minimum work experience.
• Experience in clinical research compliance, regulatory research, and/or operations in the academic or private sector.
• Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE).
• Knowledge of ICH-GCP (International Conference on Harmonization-Good Clinical Practice), DHHS (Department of Health and Human Services), OHRP (Office of Human Research Protections), and FDA regulations and procedures.
• Ability to evaluate risks and benefits of different solutions, with proven problem-solving and decision-making skills.
• Exemplary organization skills and attention to detail.
• Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements.
• Strong interpersonal and diplomatic skills for communicating with all levels of staff and varied individuals/groups.
• Demonstrated experience developing communication plans, instructional materials, and related content.
• Experience with office management communication tools (e.g., Google Suite, Slack, Skype).

Preferred Qualifications

• Bachelor’s or Master’s degree in a life science field or related area, with specific experience in clinical research and lab management.
• 3 years of experience in clinical research compliance, regulatory research, and/or operations in the academic or private sector.
• Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials.
• Advanced knowledge of regulations governing human research.