Human Subject Research Coordinator 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:

400093 Neurology-Epilepsy Unit M&D

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108 H

Compensation Range:

$25.14 - $35.24

Responsibilities:

The Epilepsy Human Subjects Research Coordinator II will provide essential research support and study coordination for several studies in the Epilepsy Division in the Department of Neurology. The research projects in the group include both investigator initiated studies, and pharmaceutical company funded multi-center clinical research studies in children and adults. The Study Coordinator II will have considerable latitude for independent judgment and coordinates all aspects of assigned human subject research studies. This role provides assistance to the Principal Investigator(s) and works as an integral part of the research team, assisting all faculty as well as residents/fellows with IRB submissions.

ESSENTIAL FUNCTIONS

• Oversees and coordinates human subject research activities including pre-screening potential study participants for multiple research studies. Must be able to learn multiple study protocols to become well versed in study requirements. HSRC will recruit participants, schedule, and conduct subject visits for research studies in accordance with study protocol.  Perform activities including but not limited to participant consent, data collection, and assessments as required per protocol. Resolves questions and concerns received from study subjects or sponsor, triaging to the Principal Investigator as necessary.
• Conducts study visits; coordinating all tasks including participant assessments, medication compliance, clinical tasks (obtaining vital signs, ECG) as well as tasks assigned to nursing staff and Principal Investigator. Complete post-visit tasks, such as shipping specimens, logging in OnCore and Advarra Payment systems and data entry into the Electronic Data Capture (EDC). Develop and monitor visit calendar for all participant visits over the life of the study. Maintain subject binder, ensuring completeness for study integrity
• Manages study start up activities, including obtaining quotes from ancillary departments (imaging, laboratory, Clinical Research Center) and modifying consent forms per UR guidelines to ready for RSRB (UR’s IRB)/ Institutional Review Board (IRB) submission. Participates in the planning, development and implementation of study design, protocols, consent forms, processes and policies. Works with Research Administration team providing expertise related to time studies and budget feasibility for study procedures, overall complexity and effort required for completing studies
• Develops and/or manages databases and source documents/case report forms (CRF’s) for research studies, ensuring CRF’s are aligned with protocol requirements. Completes data entry in a timely manner and review database(s) for incomplete items or queries
• Serves as the liaison between cross-functional research team, additional research sites, study sponsors and IRB to facilitate communication and resolve issues. Represent URMC and Principal Investigator at study meetings as needed
• Prepares and maintains regulatory and study documentation for assigned research studies.  Manages and submits amendments and continuing reviews for IRB approval. 
• Maintains essential documents for all Faculty and study personnel including CVs, licenses and training
• 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.
• 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 Good Clinical Practice 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
• Experience as Human Subject Research Coordinator I preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Word processing and data analysis software required
• Experience with eRecord preferred
• Experience using iMedidata Rave, Zelta and other EDC preferred
• Knowledge of REDCap preferred
• Experience as a Phlebotomist preferred

LICENSES AND CERTIFICATIONS

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

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