Human Subject Res Spec II

About the role

Clinical trials coordinator II for the University of Rochester Translational Pain Research Program. Responsibilities include all aspects of conducting pain clinical trials in accordance with all regulations, including recruitment, consenting, visit conduct, source documentation, data entry, and proper adverse event documentation. The coordinator will work in a highly collaborative and supportive environment with senior coordinators, a post-doctoral fellow, and lead investigator who will work together to ensure that the candidate is adequately trained before working independently.

Responsibilities

• Coordinates human subject research activities, which may include multiple site human subject studies
• May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research
• Develops, implements and evaluates recruitment strategies, information, data systems and study management systems
• Participates in the development, review and approval of case report forms (CRFs) and study-specific procedure manuals and documents
• Screen potential study participants for eligibility in clinical trials
• Conduct FDA-registration quality clinical trial visits, including, consenting, visit assessments, intervention distribution, and blood processing
• Accurately record source documentation and enter data into electronic data capture systems
• Ensure compliance with regulatory requirements and liase with study monitors
• Participate in preparing investigator-initiated clinical trial materials (e.g., protocols, consent forms, recruitment materials, assessments, participant study-related instructions)
• Other duties as assigned

Requirements

• Bachelor's degree and 2 years of experience in human subject research coordination required; Or equivalent combination of education and experience
• Word processing and data analysis software required
• Previous human subjects coordinator experience is preferred, but the position can be altered for the right candidate who is open to being trained
• Spanish fluency is highly preferred
• Ability to draw blood or willingness to be trained to draw blood is highly preferred
• Experience as a Phlebotomist preferred
• Medical background (e.g., nurse or patient care technician) is ideal, but not necessary
• SOCRA - Certification In Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred

Pay

$25.14 - $35.24 hourly

Schedule

Full time, 40 hours per week, Day shift