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Clinical Research Associate I

Buffalo, New York ~ November 07, 2018

Job Summary
Coordinate and participate in clinical research studies conducted by supervising physicians. Perform a variety of subject care and administrative duties to support activities that meet objectives of assigned research protocol(s).
Duties and Responsibilities:
Provide subject care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principals.
Ensure that IRB approval of protocol and informed consent form is obtained prior to initiation of the study.
Review subject charts, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol.
Confer with subject and physician to explain purpose of study. Explain diagnostic procedures and method of treatment to answer subject and family concerns. Obtain written consent for subject to participate in a study prior to initiation of any protocol procedures.
Maintain accurate records of the receipt, inventory, and dispensation of study drug and materials. Work with the nursing staff to administer study drug to research subjects.
Obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as described in study protocol.
Collect pertinent information and data from subject charts and records, subject interviews, and other sources. Complete case report forms (CRFs eCRF’s) in accordance with research protocol guidelines.
Inspect CRFs/eCRF’s, source documentation, and study files to ensure completeness.
Review CRFs/eCRF’s, source documentation, and study files with representative from sponsor, consortium, or Food and Drug Administration (FDA) at each visit. Make necessary corrections to CRFs/eCRF’s and submit requested documentation in a timely manner.
Comply with standard operating procedures of the sponsor, institutional review board (IRB), and facilities involved with the trial.
Compile and submit reports, documents, and correspondence as necessary to the IRB, sponsor, and facilities.
Provide training and direction to research staff or new personnel on protocol procedures.
Review journals, abstracts, and scientific literature to keep abreast of new developments.
Demonstrates appropriate managerial and interpersonal skills to provide appropriate supervision of the research associate.
Prepare IRB review materials and project status reports to Sponsor.
Reports AE’s/SAE’s promptly to Investigator/Sponsor and submits necessary documentation to IRB/Sponsor.
Maintains current knowledge and awareness of organizational and regulatory standards, policy and procedures.
Organizes monitoring visits requested by Sponsor
Provides oversight of the day-to-day operations of assigned project.
Maintains file system of program specific data to track enrollment, budget and invoicing timelines in coordination with CTO.
Administers prescribed study medications and monitor stud participants for side effects from study medications
Works closely with principal investigators to assure subjects receive appropriate medical evaluation and care

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