Rochester

Human Subject Research Spec II

270 Miracle Mile Drive, USA · Mid · Full-time

Sponsorship not specified$25k-$35kDetected 28 days ago

GCPData AnalysisClinical TrialsClinical ResearchResearchExperimental DesignLeadershipCommunicationGxP

About the role

Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability.
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.
Participates in the planning, development, and implementation of study design, budgets, protocols, consent forms, processes, and policies, including multiple therapeutic areas.
Represents sites, providers, study team, patients, study participants, and the University to develop, monitor, and maintain working relationships, positive communications, and effective results with regard to the coordination of human subject studies.
Supports the contacts and relationships between and among Principal Investigator (PI), research staff, study sites, and sponsoring and regulatory agencies.
Develops, implements, and monitors systems and methods to ensure quality, safety, efficiency, and consistency in the processing of human subject research data.
Designs, develops, implements, monitors, and manages systems and procedures to track study progression.
Implements immediate and appropriate corrective action when inconsistency of activities is identified.
Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs.
Implements and monitors resulting study changes.

Bachelor's degree and 2 years of experience in human subject research coordination required
If applicable, department specific experience required
Experience as a Phlebotomist preferred
SOCRA - Certification In Clinical Research upon hire preferred

$24.91 - $34.87
The referenced pay range represents the minimum and maximum compensation for this job.
Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

equity, leadership, integrity, openness, respect, and accountability.
Demonstrates accountability for continuous learning in accordance with GCP guidelines.
Or equivalent combination of education and experience

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better.
This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.

May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research.

This listing is sourced directly from Rochester's careers page and normalized into a canonical job model.