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Job Location (Full Address):

270 Miracle Mile Dr, Rochester, New York, United States of America, 14623

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400912 Ortho, Clinical Research

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108 H

Compensation Range:

$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.

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.

ESSENTIAL FUNCTIONS

Oversees and coordinates human subject research activities for single or multiple sites. Develops, implements, and evaluates recruitment strategies, information, data systems, and study management systems. Participates in the planning, development, and implementation of study design, budgets, protocols, consent forms, processes, and policies, including multiple therapeutic areas. Participates in the development, review, and approval of case report forms (CRFs) and study-specific procedure manuals and documents.
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. Reviews study progress, including data, finances, documentation, and reporting deliverables. Designs, develops, implements, monitors, and manages systems and procedures to track study progression.
Ensures compliance with all applicable regulatory and institutional requirements and standards. Ensures the integrity and security of all study data at all times. Initiates, monitors, and ensures all protocol activities are standardized across study sites. Implements immediate and appropriate corrective action when inconsistency of activities is identified.
Trains research coordinators and other staff on activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.
May direct the activities of subordinate staff and others to gather, compile, and analyze study information.
Coordinates and monitors financial data for budget and variance reporting and compliance with all institutional requirements for adequate system controls.
Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Demonstrates accountability for continuous learning in accordance with GCP guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs. Implements and monitors resulting study changes.
Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

Bachelor's degree and 2 years of experience in human subject research coordination required
Or equivalent combination of education and experience
If applicable, department specific experience required
Experience as a Phlebotomist preferred

KNOWLEDGE, SKILLS AND ABILITIES

Word processing and data analysis software required

LICENSES AND CERTIFICATIONS

SOCRA - Certification In Clinical Research upon hire preferred
Association of Clinical Research Professionals (ACRP) upon hire preferred

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Human Subject Research Spec II