University of Utah Clinical Research Coordinator, Sr in Salt Lake City, Utah
Open Date 07/26/2018
Requisition Number PRN17909B
Job Title Clinical Research Coordinator, Sr
Job Grade F
FLSA Code Administrative
Patient Sensitive Job Code? Yes
Standard Hours per Week 40
Full Time or Part Time? Full Time
Work Schedule Summary
VP Area U of U Health - Academics
Department 00907 - Cardiothoracic Pediatric Devel
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47,600 - 90,400
Open Until Filled Yes
The Division of Pediatric Cardiac Surgery at the University Of Utah School Of Medicine has an immediate opening for a Senior 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 senior 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 include, but are not limited to:
•Oversee, assess and ensure participant safety and strict protocol implementation/adherence; oversee compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.
•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.
•Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.
•Recognize, track and report adverse events and protocol deviations.
•Implement procedures to prevent future events, including staff education and retraining
•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 maintain IRB , FDA , NCI , NIH , NSF and/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.
Bachelors degree in a health sciences or related field with three years professional research experience and completion of University RATS Clinical 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 , HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
Departments may require IRB CITI Course or IATA DGR training 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.
•Registered nurse along with experience in the pediatrics and/or cardiovascular clinical research areas is preferred. Five years of professional clinical research experience, credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), or other related certification will be favorably considered.
Type Benefited Staff
Special Instructions Summary
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.
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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.