- 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.
- 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.
- Conducts or assist during study 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.
- Prepare for upcoming visits with senior coordinator assistance, including printing source documents, consent form, any study required supplies (e.g. blood draw kit, skin biopsy).
- Assist in human subject study visit activities, including completing source documents, vitals and EKG, perform study related task/procedures as well as data entry after visit.
- Assist in samples processing, storage or shipping as per study protocol.
- Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
- Acts as liaison with Sponsor's 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).
- 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. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies. Makes recommendations and implements changes as appropriate.
- Bachelor's degree or
- Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required
- Or equivalent combination of education and experience
- Experience as a Phlebotomist
- Word processing and data analysis software
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Human Subject Res Coord I - Rochester, United States - University of Rochester
Description
OpeningFull Time 40 hours Range URG 106 Dermatology M&D
Schedule
8 AM-5 PM
Responsibilities
GENERAL PURPOSE:
Coordinates the activities associated with human subject research.
SPECIFIC RESPONSIBILITIES:
¿¿¿¿¿
REQUIREMENTS:
Required:
Preferred:
NOTE:
This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University's mission to Learn, Discover, Heal, Create - and Make the World Ever Better.
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.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range:
$ $29.29 Hourly
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.