Neurology Study Coordinator - Rochester, United States - GreaterROC

Description

OpeningFull Time 40 hours Grade 051 General Neurology UnitSchedule8 AM-4:30 PMResponsibilities


POSITION SUMMARY:
Coordinates all aspects of assigned research studies associated with human subject research. Provides assistance to the Principal Investigator and works as an integral part of the study team.


SUPERVISION AND DIRECTION EXERCISED:
May be responsible for training new staff/student workers as determined by Program Manager/Principal Investigator

SUPERVISION AND DIRECTION RECEIVED:
Under the direct supervision of the Principal Investigators or designee for assigned studies

TYPICAL DUTIES:

Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others.

(20%)Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria.

May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.

(20%)Conducts visits to ensure research participant adherence with protocol requirements, such as taking of medications, proper use of device, and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities.

Ensures all data are collected and secured within approved parameters and procedures.

(20%)Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures, and standards for documentation and communication.

Under general direction from the Principal Investigator (PI), trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting.

(15%)Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations.

Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Manages the regulatory details for assigned research studies. Prepares and maintains regulatory and study documentation. Manages and submits amendments and continuing reviews for IRB approval. Ensures all regulatory requirements are met and documented.

(10%)Acts as liaison with Sponsors Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review.

Communicates with Sponsor to clarify data queries to determine report format. Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits). (10%)Other duties as assigned (5%)


QUALIFICATIONS:

Bachelors degree and one year of experience in human subject research coordination; or an equivalent combination of education and experience.

Knowledge of word processing, spreadsheets, and electronic data capture (EDC) software preferred. Must have excellent communication skills.


NOTE:

This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.

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In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law.

This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To ApplyAll applicants must apply online.
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