University of Rochester Human Subject Res Coord I in Rochester, New York
Full Time 40 hours Grade 051 OBGYN Research
8 AM-4:30 PM; OCC WKENDS
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. 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.
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.
- 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 laboratory; insure 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.
- Attend team meetings and conference calls as needed.
- Interact with clinical staff to schedule ultrasound examinations for study participants.
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 a vehicle to travel between study locations (reliable/efficient transportation).
This position requires the ability to work independently. The candidate must possess strong interpersonal skills in order to communicate with subjects, team mates, and other hospital staff. The applicant must be willing to develop the logistics of subject enrollment, be persistent and flexible in assuring on-going subject cooperation/compliance, and possess excellent data collection skills. Computer skills required. The position will require travel to several medical offices in the Rochester area for subject enrollment, chart verification, training, and recruitment.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord I
Location: School of Medicine & Dentistry
Job ID: 207197
Full/Part Time: Full-Time