Human Subjects Research Coordinator 1

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Job Location (Full Address):

601 Elmwood Ave, Room 24309, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400153 OBGYN Research

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.36 - $29.90

Responsibilities:

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.

ESSENTIAL FUNCTIONS

Engagement and monitoring of study subjects (50%):

40%   Schedule and conduct study visits, consenting participants and explaining study protocols to ensure patient compliance. Works independently with input from the PI. Is responsible for subject tracking, administering the study vitamin D on the first study day, drawing blood, processing biological sampling, ensuring form completion, and adherence to protocol.

5%    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.

5%    Study administration, 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 (40%):

10%   Completes interviews and phone calls with subjects as required by protocol.

10%   Completion of source documents: CRFs, follow up phone calls, and subject mailings.

5%    Provide collection, labeling, and coordination of study specimens to be delivered to the core laboratory; ensure labeling is correct and coordinate sample shipments to Cornell.

5%    Perform chart reviews and information abstraction/recording, phone communications with subjects, fax/mail as necessary as pertains to enrolled subjects at your site.

5%    Perform data entry and integrity checks; enter data into web based database and respond to sponsor data queries as they arise. 

5%    Interface with study monitors to answer any questions and keep complete regulatory and subject documentation.

Research Team Collaboration (10%):

5%    Coordinate with the PI, the sponsor, and the data monitors to ensure regulatory and other documents are complete and on time.

5%    Attend team meetings and conference calls as needed.

Required Competencies

This position requires the ability to work independently.  The candidate must possess strong organizational and 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, be detail oriented, and possess excellent data collection skills.  Computer skills required. 

REQUIREMETS:

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.  

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