University of Utah Clinical Data Manager II in Salt Lake City, Utah

Details

Open Date 01/31/2017

Requisition Number PRN13423B

Job Title Clinical Data Manager II

Working Title Research Data Coordniator

Job Grade E

FLSA Code Administrative

Patient Care Job Code? No

Standard Hours per Week 40 hours

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

M-F, 8-5.

VP Area Health Sciences

Department 01167 - HCI Clinical Trials Operations

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 39,300 to 55,000

Close Date

NOTE: May close at anytime.

Open Until Filled

NOTE: May close at anytime. Yes

Job Summary

The Research Data Coordinator is responsible for managing the technical and administrative details involved in the data collection and maintenance for a clinical trial. TheRDCwill work with the principal investigator, study staff and monitors to ensure quality data, and will assist the principal investigator in achieving data integrity and study objectives through the successful implementation and completion of protocol data requirements, and when necessary, patient contact will be required to facilitate clinical research coordination efforts.

Responsibilities

Assess the study protocol for clarity and subject safety, review inclusion/exclusion criteria, and clarify questions and concerns with the principal investigator and sponsor.

Attend and participate in investigator and staff study meetings; advise team regarding specific study assignments and timelines.

Obtain study patients’ medical history and demographics; maintain subject log as well as subject’s source documentation (including historical data, status reports, progress notes, laboratory and imaging results, etc.).

Report and track adverse events; report serious adverse events to the sponsor,IRB, and to the Data and Safety Monitoring Committee.

Collect and maintain protocol-required study data and records in physical or electronic patient research chart.

Enter study data into case report forms (CRF); maintain a current and accurate studyCRFdatabase; and complete, correct and submit CRFs to the study sponsor.

Schedule, coordinate and participate in interim monitoring visits and study closure monitoring visits; address queries and make corrections to study data, as appropriate. Prepare and complete study-related documentation such as protocol worksheets, logs, procedural manuals, adverse event reports and progress reports.

Request protocol-required archival pathology specimens.

Collect and submit or upload protocol-required radiology and other imaging data.

Collect study data from patients in long-term follow-up, including search of the electronic medical record system, or communication with the patient via mail or phone call (otherwise, this position has very little interaction with study subjects).

Confirm or verify protocol deviations, reconcile test article accountability at study close out and prepare reports for sponsor.

Maintain data and documents as required byFDAguidelines.

Perform functions required of the Clinical Research Coordinator as necessary, including but not limited to patient informed consent, patient scheduling, and patient visits, etc. as necessary to assist with study compliance.

May maintain contact withIRBand prepare and submitIRBdocuments.

May help to ensure proper collection, processing and shipment of specimens.

Minimum Qualifications

Bachelor’s degree in the life sciences, pharmacy, nursing, a related subject, or equivalency.

Requires two or more years of relevant clinical data management experience.

Understanding of basic regulations involving clinical trials, clinical data management, and clinical data systems.

Ability to perform all data management activities associated with a clinical trial with a high degree of quality.

Possess all skills, knowledge and competencies required of theCDMI position.

Preferences

Type Benefited Staff

Special Instructions Summary

Additional Information

The University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.

To inquire about this posting, email: employment@utah.edu or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/ TDD ), email: oeo@umail.utah.edu .

The University is a participating employer with Utah Retirement Systems (“URS”). To be eligible for retirement contributions, you must be hired into a benefit-eligible position. Certain new hires are automatically assigned to the URS retirement plan and other employees with prior URS service, may elect to enroll in the URS within 30 days of hire. Regardless of whether they are hired into a benefit-eligible position or not, individuals who previously retired and are receiving monthly retirement benefits from URS must notify the Benefits Department upon hire. Please contact Utah Retirement Systems at (801)366-7770 or (800)695-4877 or the University’s Benefits Department at (801)581-7447 for information.

This position may require the successful completion of a criminal background check and/or drug screen.