With limited supervision, the Senior Research Coordinator supports multiple projects and/or Principal Investigators, gathering patient data via methods specified in the study protocol and providing general administrative duties in support of the study. Independently coordinates, directs, and implements the more advance and complex research protocols. Ensures accurate data collection, documentation organization, and safety of study volunteers.
PATIENT AGE GROUP SERVED
Indirect patient care.
DUTIES AND RESPONSIBILITIES
Attends and participates in the Investigator meeting. (EF)
Reviews goals and requirements of any new protocols and coordinates study initiation. (EF)
Supervises preparation of all IRB and Regulatory Documents; under direction of PI may draft various communications with Sponsor. (EF)
Assesses staffing needs based upon current research activity and implements changes in staffing as needed. (EF)
Participates in pre-site and site initiation visits. (EF)
Plans and designs source documentation for protocol. (EF)
Develops assessment tool per protocol to use in clinical research and teaches research team how to use the assessment tool. (EF)
Develops procedures for laboratory collection and storage. (EF)
Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary; mentors all clinical research personnel regarding enrollment/recruitment. (EF)
May assist PI in obtaining Informed Consent process from study participant and documents appropriately. (EF)
Completes an initial patient assessment utilizing interview, observation, and examination; obtains Vital Signs and performs phlebotomy; teaches proper procedures to research coordinator and research coordinator assistant. (EF)
Identifies the patient at risk, psychologically, and physiologically. (EF)
Monitors participants labs and notifies the PI of laboratory findings. (EF)
Maintains accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, reconciling study drug accountability; monitors documentation for quality and accuracy. (EF)
Conducts reviews of on-going studies and oversees quality assurance on ongoing protocols; productive working relationship with the study monitor. (EF)
Conducts in-service to floor nurses/physicians. (EF) Precepts new clinical research staff and educates research staff regarding scientific aspects of studies. (EF)
Serves as a role model and resource for the clinical research staff. (EF) Provides performance management for staff under direction of PI. (EF)
Assesses communication process within Department and/or services required by the protocol. (EF)
Elicits relevant data from sources outside of the hospital. (EF)
Assists PI in budget development; may monitor ledgers. (EF)
Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; ensures return of test article /clinical supplies; maintains regulatory standards. (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 degree in Basic Science
Three years experience as a research coordinator.
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
CCRC or CCRP.
Standard laboratory environment; Some assignments may be in hospital units with typical hospital environmental hazards and concerns.
Houston Methodist - 15 months ago