Human Subjects Research Coordinator I Job at University of Rochester (Rochester)

Job Description

This is a full-time position (40 hrs/wk) in Ob/Gyn to conduct clinical research study among pregnant women. In particular this individual will be responsible for recruitment and administrative responsibilities for one NIH funded study under the direction of the Principal Investigator. This individual will screen and recruit potential study candidates and perform interviews, data/specimen collection, chart reviews, and data entry. Must work well as part of a team, be able to complete project tasks independently as requested, be comfortable with a variety of databases, be detail-oriented, and at all times demonstrate the ability to interact in a professional and positive manner in both verbal and written communications.

Job Responsibility

Engagement and monitoring of study subjects (50%): Schedule and conduct study visits, consenting participants and explaining study protocols to ensure patient compliance
Subject tracking, administering the study vitamin D on the first study day, drawing blood, processing biological sampling, ensuring form completion, and adherence to protocol
Assist in developing protocol with PI, recruitment strategies, and monitors target enrollment numbers
Inform Cornell study team when subjects complete study and need to be reimbursed
Interface with PI at Cornell to update on enrollment status and any issues that arise during the study
Study administration, participates in advertising material development, and coordination of study with PI
Information Management (40%): Completes interviews and phone calls with subjects as required by protocol
Completion of source documents: CRFs, follow up phone calls, and subject mailings
Provide collection, labeling, and coordination of study specimens to be delivered to the core laboratory
Perform chart reviews and information abstraction/recording, phone communications with subjects, fax/mail as necessary as pertains to enrolled subjects at your site
Perform data entry and integrity checks
enter data into web based database and respond to sponsor data queries as they arise
Interface with study monitors to answer any questions and keep complete regulatory and subject documentation
Research Team Collaboration (10%): Coordinate with the PI, the sponsor, and the data monitors to ensure regulatory and other documents are complete and on time
Attend team meetings and conference calls as needed

Requirements

Bachelor's degree and 3 years’ experience in clinical research coordination
or an equivalent combination of education and experience
Phlebotomy training and certification required
Knowledge of Microsoft Office and Windows software preferred
Experience with data entry or management preferred
Clinical Research Coordinator Certification preferred
Must be able to work occasional weekends and in late afternoons/early evenings on some weekdays
Ability to work independently
Strong organizational and interpersonal skills
Willing to develop the logistics of subject enrollment
Persistent and flexible in assuring on-going subject cooperation/compliance
Detail oriented
Excellent data collection skills
Computer skills required

Nice to have

Knowledge of Microsoft Office and Windows software
Experience with data entry or management
Clinical Research Coordinator Certification

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