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

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Full Time 40 hours Grade 051 OBGYN Research

Schedule

8 AM-4:30 PM; OCC WKENDS/HOL

Responsibilities

Position Summary:

This is a full-time position (40 hrs/wk) in Ob/Gyn to conduct clinical research studies. In particular this individual will be responsible for recruitment and administrative responsibilities for several studies under the direction of the Principal Investigator(s). 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.

Responsibilities:

Screening, recruitment, and monitoring of study subjects:

  • Uses independent judgment to identify subject pool and screen eligible patients to make sure they meet enrollment criteria and are likely to be compliant with study procedures over the course of the study. explain study and obtain informed consent.
  • Schedule and conduct study visits to ensure patient compliance with project protocol. Works independently with input from the PI. Is responsible for subject tracking, ensuring form completion, and adherence to protocol.
  • Assist in developing protocol with PI, recruitment strategies, and monitors target enrollment numbers. Manage and track all subject incentive payments with petty cash. Interface with PI to update on enrollment status and any issues that arise during the study.
  • Study administration, form creation, participates in advertising material development, and coordination of study with PI. Is solely responsible for the day-to-day operations of the study and must use independent judgment.

Information management:

Completes interviews and phone calls with subjects as required by protocol.

  • Completion of source documents: CRFs, follow up phone calls, and subject mailings. Prepare reports and compile information from eRecord and other sources.
  • Provide collection, labeling, and coordination of study specimens to be delivered to the laboratory; ensure labeling is sequential and interfaces with lab labeling system.
  • 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:

  • Coordinate with the PI, the sponsor, and the data monitors to ensure regulatory and other documents are complete and on time. Assist with outreach visits and meetings to ensure the success of the project.
  • Attend team meetings and conference calls as needed.
  • Interact with clinical staff to schedule visits for study participants.

Qualifications:

Bachelor's degree and 1-2 years experience in clinical research coordination; or an equivalent combination of education and experience. Knowledge of Microsoft Office 2010 and Windows 2007 software preferred. Experience with data entry or management preferred. Clinical Research Coordinator Certification preferred. Phlebotomy training preferred. Must have an independent vehicle to travel between study locations (reliable/efficient transportation)

EOE Minorities/Females/Protected Veterans/Disabled

Job Title: Human Subject Res Coord I

Location: School of Medicine & Dentistry

Job ID: 210746

Regular/Temporary: Regular

Full/Part Time: Full-Time