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University of Rochester Human Subject Res Coord I - 225609 in Rochester, New York

Human Subject Res Coord I Job ID 225609

Location Eastman Dental Center Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours EIOH Research Admin Core

Schedule

8:30 AM-5:00 PM

Responsibilities

JOB DESCRIPTION

Job Summary: The research coordinator will provide overall coordination of the funded and non-funded clinical studies within EIOH. The individual must be able to work independently with minimal supervision. Excellent interpersonal skills, writing skills, and computer skills are required. Knowledge of RSRB policies, procedures and submission process extremely helpful.

Responsibilities:

15% Research quality assurances – Ensures all team members understand and adhere to all aspects of approved protocols, procedures, and standards for documentation and communication. Under direction from the Principal Investigator, trains staff on details of protocol, including inclusion and exclusion of criteria, informed consent procedures, study activities, and adverse event reporting to sponsor and RSRB.

15% Maintain close contact with the Principal Investigator and research team for recruitment activities, and general daily communication and practices timely communication with the study subjects.

15% Enters study data and ensures for completeness of data and/or performs the duplicate data entry.

10% Coordinate the administrative details required to initiate and conduct human subject research, such as receiving, distributing, and explaining study information – including protocol and human subject recruitment materials (e.g. advertisements, brochures, newsletters) to immediate team members and relevant others.

10% Train staff, under general direction from the Principal Investigator, on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting.

10% Maintains compliance with regulatory documents, such as informed consent documents, case report forms, enrollment logs, drug/device accountability logs, etc.

10% Responsible for the execution of protocol activities, such as, provide data clarifications; review study protocols; respond to questions that arise during study activities; communicate and documents adverse events as advised by the Principal Investigator; ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate, and available for review and quality assurance.

5% Keep current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures and guidelines, and make recommendations.

5% Demonstrate accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.

5% Keep current with industry standards, best practices, trends in therapeutic areas relevant to research studies, and then make recommendations and implement changes as appropriate.

Qualifications:

Minimum requirements: Bachelor's degree and 1 year of experience in human subject research coordination; or equivalent combination of education and experience. Knowledge of word processing and data analysis software is preferred. Preferred experience coordinating clinical research projects. Well versed in URMC standard operating procedures and human subject protection. Proficiency with Microsoft Office required. Dental experience preferred.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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