Coordinator

Position Summary:

Position Summary

Serves as a research nurse on multiple clinical research studies for various sponsors including government agencies, cooperative groups, pharmaceutical companies, biotechnology companies, and/or medical device companies. Must follow the study protocol as designed and written by the study sponsor adhering to Good Clinical Practice as defined by the U.S. Food and Drug Administration, as well as other appropriate Regulatory agencies. May perform study related procedures for which trained and under the direction of the Principal or Sub-Investigator physician.

Service

Responds to inquires or contacts in a variety of circumstance representing UTMC and the Office of Clinical Trials to internal and external customers.
a. Greets patients, families and each other with a 'SMILE'.
b. Acts as patient/customer liaison: Maintains patient confidentiality.
c. Partners with patients, physicians, and research nurses in the planning of care.
d. Responds to phone calls and written requests in a courteous, timely manner.
e. Assists within reason to resolve complaints, requests, or customer concerns.
f. Maintains composure under stressful conditions.
g. Handles conflict with diplomacy and presents a professional attitude and appearance.

Discusses participation in studies with patients and obtains informed consent.
a. Follows informed consent guidelines with 100% accuracy.
b. Documents all informed consents declined with reason patient declined to participate.

Efficiency and Effectiveness

Identifies strategies to improve patient enrollment in research protocols.
a. Presents at least one new suggestion monthly to improve patient enrollment.
b. Attends and actively participates in all department required meetings.

Screens patient records, databases, physician referrals, etc., to identify prospective patients for studies.
a. Screens all available records daily, as assigned.
b. Reports screening results to applicable coordinator within two (2) business days.

Provides or enters study data into Clinical Trials Management System (CTMS) for all assigned studies.
a. CTMS study data updated at least weekly within three (3) business days following end of week.
b. Data provided/entered with 100% accuracy.

Provides nursing care to research study patients.
a. Ensures compliance with each study's protocol by providing thorough review and documentation at each subject study visit.
b. Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.
c. Performs medical tests, including, but not limited to, vital signs, imaging studies, and electrocardiograms.
d. Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects; notifies Principal Investigator of findings/issues.
e. Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.
f. Documents medical data in patient research charts to capture protocol requirements.

Manages quality assurance audits, other periodic reviews, and data queries.
a. Performs trial audit at least monthly.
b. Provides audit reports to Office of Clinical Trials (OCT) leadership within 1 week of audit.

Coordinates collection of data per protocol, operations manuals, CRF guidelines, and enters data into eCRF systems.
a. Collects data within three (3) business days of patients visit or procedures performance.
b. Ensures that all data is documented per ALCOA guidelines and provided to the Data Coordinator within (3) days of patient visit or procedure and is at least 95% accurate.

Quality and Safety

Performs procedures for multiple clinical research studies as outlined in the research protocol in compliance with FDA regulations and GCP.
a. Follows protocol with 95% accuracy.
b. Complies with GCP without exception.
c. Any deviations/issues are reported to the PI and OCT leadership within 24 hours.

Monitors study participants' clinical status and reports adverse and serious events to Sponsor and PI in accordance with protocol and Sponsor direction.
a. Ensures that all AEs and/or SAEs are reported with 100% accuracy.
b. Ensures that reporting timeline is adhered to with 100% accuracy.

Position Qualification:

3-5 Years of Healthcare/Medical Experience Required

-RN Preferred

-Clinical experience required.

-Research experience preferred

Years of Experience can be related experience and/or training; or equivalent combination of education and experience.