Human Subject Research Spec II

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Job Location (Full Address):

220 Hutchison Rd, Rochester, New York, United States of America, 14620

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400075 Breastfeeding & Lactation Med

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108 H

Compensation Range:

$25.14 - $35.24

Responsibilities:

Coordinates human subject research activities, which may include multiple site human subject studies in the field of Breastfeeding and Lactation Medicine. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. May supervisor others. This position involves working with breastfeeding and lactating families, managing study documents and workflow, collecting and processing study samples, and managing regulatory aspects of clinical research studies.

ESSENTIAL FUNCTIONS

• Oversees and coordinates human subject research activities for single or multiple sites.  Develops, implements and evaluates recruitment strategies, information and data systems and study management systems.  Participates in the planning, development and implementation of study design, budgets, protocols, consent forms, processes and policies that may include 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 for the purpose of tracking 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 that 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.
• Directs the activities of subordinate staff and relevant others to gather, compile and analyze study information.
• Coordinates and monitors financial data for budget and variance reporting and for 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 (3 years preferred).
• Or equivalent combination of education and experience
• Experience as Human Subject Research Coordinator I preferred
• Experience working with perinatal populations and/or infants preferred
• 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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