The Research Coordinator coordinates and gathers patient data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.
DUTIES AND RESPONSIBILITIES
May attend and participate in the Investigator meeting. (EF)
Prepares IRB documents under the direction of the PI and assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval. (EF)
Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation. (EF)
Under direction of PI may draft various communications with Sponsor and/or regulatory documents to be sent to the Sponsor. (EF)
Assists PI and/or research nurse coordinator in the planning and design of source documents for protocol. (EF)
Assists in developing procedures for laboratory collection and storage. (EF)
Identifies and recruits clinical research subjects and monitors enrollment goals; mentors research coordinator assistant regarding enrollment and recruitment. (EF)
May assist PI in obtaining Informed Consent from study participant and documents appropriately. (EF)
Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital. (EF)
Completes an initial patient assessment utilizing interview and observation; assists in identifying the patient at risk, psychologically, and physiologically. (EF)
If appropriately trained and tested for competency, obtains Vital Signs and performs phlebotomy; monitors participants' labs and notifies the PI of laboratory findings. (EF)
May conduct in-service to floor nurses/physicians; assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies. (EF)
Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process. (EF)
Reconciles study drug accountability; maintains temperature and QC logs per protocol compliance. (EF)
Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards. (EF)
Develops and maintains productive working relationship with the study monitor; attends and participates in campus coordinator workshops. (EF)
Assists with the budget development; may monitor ledgers. (EF)
Adheres to internal controls established for department. (EF)
Demonstrates the components of the ICARE values statement.
Follows all safety rules while on the job. Reports accidents promptly and corrects minor safety hazards. Completes all hospital required and job-related in-services and applies the information s needed.
Performs other duties as assigned.
Bachelor's degree preferred.
Two to five years of related research coordinator experience.
CCRC or CCRP preferred.
Standard laboratory environment; Some assignments may be in hospital units with typical hospital environmental hazards and concerns.
Methodist Hospital System - 10 months ago