RESEARCH COORDINATOR II- CV Surgery Clinical Trials
The Methodist Research Institute - Houston, TX

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JOB SUMMARY

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 study-specific documents under the direction of the PI and assists Regulatory Specialist and PI with answering IRB stipulations to obtain final approval

Maintains records for study subjects including informed consents, source documents, sponsor correspondence, paper and/or electronic case report forms and assists with regulatory documents (adverse event reporting, continuing reviews and study closures) as indicated by Regulatory staff.

Schedules, coordinates, and participates in the site initiation visits; coordinates study initiation as well as all monitoring visits and study closure visits(EF)

Under direction of PI may draft various communications with Sponsor as required.(EF)

Assists PI and/or study team in the planning and design of source documents for protocol. Maintains clean copies of source and assists with revisions as required. (EF)

Assists in developing procedures for laboratory collection and storage. (EF)

Identifies and recruits clinical research subjects and monitors enrollment goals; identifies enrollment issues and alerts study team for problem solving. (EF)

May assist PI in obtaining Informed Consent from study participants and documents appropriately. (EF)

Completes paper-based and electronic case report forms accurately and efficiently

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 obtains PI signature from review of laboratory findings in a timely manner. (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)

Schedule appointments for tests and procedures for research subjects.

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/device accountability; maintains all drug/device l 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 relationships with the study monitor and study team; attends and participates in campus coordinator workshops. (EF)

Assists with the budget development; completes financial reconciliation for completed study procedures against schedule of events. (EF)

Utilizes CTMS to enter study/subject specific information according to the study schedule of events so that appropriate tracking of study subjects/schedule of events can be maintained.

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 as needed.

May conduct work-related duties in an office setting, clinic environment, hospital patient care areas or cath lab/operating room. Must be prepared for possible disturbing visual images (wounds, surgical procedures).

Performs other duties as assigned.

EDUCATION REQUIREMENTS

Bachelor's degree preferred.

EXPERIENCE REQUIREMENTS

Two to five years of related research experience.

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

CCRC or CCRP preferred.

SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

WORKING ENVIRONMENT

Office setting; Standard laboratory environment; Some assignments may be in hospital units or clinical areas with typical hospital environmental hazards and concerns.

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