UTMB Health
Coord (Clinical Research - Galveston)
UTMB Health, Galveston, Texas, United States, 77554
Coord (Clinical Research - Galveston)
Galveston, Texas, United States
New
Research Academic & Clinical
UTMB Health
Requisition # 2405562
REQUIRED EDUCATION / EXPERIENCE:
Bachelor’s degree or equivalent, and two years of directly related experience.
JOB SUMMARY:
The Clinical Research Coordinator obtains human subject data for clinical research activities via
methods specified in the study protocol and performs general administrative duties supporting
the study.
ESSENTIAL JOB FUNCTIONS:
Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other
regulatory activities.
Schedules, coordinates, and participates in the pre-site visit and site initiation visits;
coordinates study initiation.
Maintains and monitors source documentation and appropriate forms as per protocol for
quality and accuracy, including participant records; assists with the quality assurance
process.
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.
Reconciles study drug accountability; maintains temperature and QC logs per protocol
compliance.
Develops and maintains productive working relationship with the study monitor; attends
and participates in campus coordinator workshops.
Identifies and recruits clinical research subjects for participation of studies, collects data,
and monitors enrollment goals.
Mentors new clinical research coordinators and assistant clinical research coordinators..
Assists with grant/protocol preparation and submission to IRB, OCR or OSP
under direction of research coordinator under the direction of the PI and with answering
IRB stipulations to obtain final approval; documents IRB approval and contract approval
Under direction of PI may draft various communications with Sponsor and/or regulatory
documents to be sent to the Sponsor.
May assist PI and/or research nurse coordinator in the planning and design of source
documents for protocol.
Assists in developing procedures for laboratory collection and storage.
Assists in processing and shipping lab specimens; retrieves and/or sends identified
research specimens certified if indicated as per regulations
Assists in precepting new clinical research staff and educating other research staff
regarding scientific aspects of studies.
Assists in processing and shipping lab specimens efficiently and cost effectively;
maintains supply inventory and equipment; maintains regulatory standards.
Assists with the budget development; may monitor ledgers.
Adheres to internal controls established for department.
May assist PI in obtaining Informed Consent from study participant and documents
appropriately.
Adheres to internal controls and reporting structure.
MARGINAL OR PERIODIC JOB FUNCTIONS:
If appropriately trained and tested for competency, obtains Vital Signs and performs
phlebotomy; monitors participants’ labs and notifies the PI of laboratory findings
May attend and participate in the Investigator meeting
Performs related duties as required.
EQUIPMENT:
Standard office equipment.
WORKING ENVIRONMENT/LOCATION OF POSITION:
Standard hospital, clinical, laboratory and/or office environments.
OTHER:
Specific job requirements or physical location of some positions allocated to this classification,
may render this position security sensitive, and thereby subject to the provisions of Section
51.215, Texas Education Code.
Salary Range: The salary range $34,960 - $52,440
Equal Employment Opportunity
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities.
Compensation
Galveston, Texas, United States
New
Research Academic & Clinical
UTMB Health
Requisition # 2405562
REQUIRED EDUCATION / EXPERIENCE:
Bachelor’s degree or equivalent, and two years of directly related experience.
JOB SUMMARY:
The Clinical Research Coordinator obtains human subject data for clinical research activities via
methods specified in the study protocol and performs general administrative duties supporting
the study.
ESSENTIAL JOB FUNCTIONS:
Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other
regulatory activities.
Schedules, coordinates, and participates in the pre-site visit and site initiation visits;
coordinates study initiation.
Maintains and monitors source documentation and appropriate forms as per protocol for
quality and accuracy, including participant records; assists with the quality assurance
process.
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.
Reconciles study drug accountability; maintains temperature and QC logs per protocol
compliance.
Develops and maintains productive working relationship with the study monitor; attends
and participates in campus coordinator workshops.
Identifies and recruits clinical research subjects for participation of studies, collects data,
and monitors enrollment goals.
Mentors new clinical research coordinators and assistant clinical research coordinators..
Assists with grant/protocol preparation and submission to IRB, OCR or OSP
under direction of research coordinator under the direction of the PI and with answering
IRB stipulations to obtain final approval; documents IRB approval and contract approval
Under direction of PI may draft various communications with Sponsor and/or regulatory
documents to be sent to the Sponsor.
May assist PI and/or research nurse coordinator in the planning and design of source
documents for protocol.
Assists in developing procedures for laboratory collection and storage.
Assists in processing and shipping lab specimens; retrieves and/or sends identified
research specimens certified if indicated as per regulations
Assists in precepting new clinical research staff and educating other research staff
regarding scientific aspects of studies.
Assists in processing and shipping lab specimens efficiently and cost effectively;
maintains supply inventory and equipment; maintains regulatory standards.
Assists with the budget development; may monitor ledgers.
Adheres to internal controls established for department.
May assist PI in obtaining Informed Consent from study participant and documents
appropriately.
Adheres to internal controls and reporting structure.
MARGINAL OR PERIODIC JOB FUNCTIONS:
If appropriately trained and tested for competency, obtains Vital Signs and performs
phlebotomy; monitors participants’ labs and notifies the PI of laboratory findings
May attend and participate in the Investigator meeting
Performs related duties as required.
EQUIPMENT:
Standard office equipment.
WORKING ENVIRONMENT/LOCATION OF POSITION:
Standard hospital, clinical, laboratory and/or office environments.
OTHER:
Specific job requirements or physical location of some positions allocated to this classification,
may render this position security sensitive, and thereby subject to the provisions of Section
51.215, Texas Education Code.
Salary Range: The salary range $34,960 - $52,440
Equal Employment Opportunity
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities.
Compensation