University of Utah Clinical Research Coordinator in Salt Lake City, Utah

Details

Open Date 06/06/2018

Requisition Number PRN17392B

Job Title Clinical Research Coordinator

Working Title Clinical Research Coordinator

Job Grade E

FLSA Code Administrative

Patient Sensitive Job Code? No

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

weekdays

VP Area U of U Health - Academics

Department 00907 - Cardiothoracic Pediatric Devel

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 39300 to 72700

Close Date

Open Until Filled Yes

Job Summary

The Division of Pediatric Cardiac Surgery at the University Of Utah School Of Medicine has an immediate opening for a Clinical Research Coordinator. The Clinical Research Coordinator will provide support to Principal Investigators within the Pediatric Heart Center. The incumbent will be responsible for coordination, implementation, quality control and completion of research studies while accomplishing study objectives and maintaining compliance with guidelines set by government agencies.

An experienced research coordinator with an RN license is strongly preferred. The licensed professional will use medical knowledge and clinical experience broadly in multiple functions of this position, including but not limited to analyzing and/or evaluating clinical data, developing and implementing clinical workflows for studies/protocols, performing medical reviews, and training clinical research coordinators within the Pediatric Heart Center.

Responsibilities

Responsibilities include, but are not limited to:

•Collaborate with primary investigators to develop and conduct local and national research studies as assigned by the Administrative Director of Pediatric Heart Center Research.

•Assist in the development of study materials and protocols; oversee compliance to protocol; manage quality control, completion and submission of study related documentation; prepare reports for organizations and agencies.

•Assist in development of study budgets; monitor budget expenses for allied services; maintain all billing, incentive, and reimbursement records.

•Participate in a call schedule for enrollment as dictated by the study protocol.

•Monitor enrollment goals and initiate strategies to promote enrollment and participant compliance. Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.

•Recognize, track and report adverse events and protocol deviations.

•Prepare for and coordinate site visits made by sponsors or federal agencies during the course of and at the close of the study.

•Prepare, submit and maintainIRB,FDA,NCI,NIH,NSFand/or other regulatory documents and research correspondence.

•Develop and maintain patient databases, investigational logs and records of drugs administered and/or procedures followed.

•Create and maintain a system to track data entry and audit for completeness, accuracy, and timeliness of data collection.

•Provide cross-coverage of prospectively enrolling studies to avoid compromising accrual in the absence of the primary study coordinator. These will be assigned by the Administrative Director of Pediatric Heart Center Research.

•Integrate with the Pediatric Heart Center research coordinator team by attending all coordinator meetings, protocol meetings, monthly Pediatric Heart Center Research meetings, monthly Pediatric CT Surgery research planning meetings, and additional meetings as determined by the Administrative Director of Pediatric Heart Center Research.

•Collaborate with others to advance cost-effective, efficient, and robust research across disciplines/subspecialties (Surgery, Cardiology, Critical Care) of the Pediatric Heart Center Research Enterprise.

The licensed professional responsibilities may also include:

•Performs medical reviews analyzing or evaluating clinical data and serves as a team resource for non-clinician staff.

•Administers investigational drugs and monitors side effects.

•Performs investigational surgical or radiological procedures and detailed clinical assessments.

•Provides nursing care as necessitated by the response of the participant to the study intervention.

•Recognize, track and report adverse events and protocol deviations.

•Prepare for and coordinate site visits made by sponsors or federal agencies during the course of and at the close of the study.

•Prepare, submit and maintainIRB,FDA,NCI,NIH,NSFand/or other regulatory documents and research correspondence.

•Develop and maintain patient databases, investigational logs and records of drugs administered and/or procedures followed.

•Create and maintain a system to track data entry and audit for completeness, accuracy, and timeliness of data collection.

•Provide cross-coverage of prospectively enrolling studies to avoid compromising accrual in the absence of the primary study coordinator. These will be assigned by the Administrative Director of Pediatric Heart Center Research.

•Integrate with the Pediatric Heart Center research coordinator team by attending all coordinator meetings, protocol meetings, monthly Pediatric Heart Center Research meetings, monthly Pediatric CT Surgery research planning meetings, and additional meetings as determined by the Administrative Director of Pediatric Heart Center Research.

•Collaborate with others to advance cost-effective, efficient, and robust research across disciplines/subspecialties (Surgery, Cardiology, Critical Care) of the Pediatric Heart Center Research Enterprise.

The licensed professional responsibilities may also include:

•Performs medical reviews analyzing or evaluating clinical data and serves as a team resource for non-clinician staff.

•Administers investigational drugs and monitors side effects.

•Performs investigational surgical or radiological procedures and detailed clinical assessments.

•Provides nursing care as necessitated by the response of the participant to the study intervention.

This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Work Environment and Level of Frequency that may be required:

Nearly Continuously: Office environment.

Seldom: Infectious disease, oils ( there is air or skin exposure to oils or other cutting fluids ).

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking, standing, sitting.

Seldom: Bending, reaching overhead.

Minimum Qualifications

Bachelors degree in a health sciences or related field with two years professional research experience and completion of UniversityRATSClinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.

Knowledge of Good Clinical Practices,FDA,HIPAAandIRBregulations; an understanding of research procedures; and the ability to function independently is preferred.

Departments may requireIRBCITICourse orIATADGRtraining within a specified timeframe.

Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

•RN license in the State of Utah

•Experience in the pediatrics or cardiovascular clinical research areas

•Five years of professional clinical research experience

•Credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or other related certification

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.