PS Study Coordinator

The University of Utah • Salt Lake, UT

4d • Onsite

About The Position

The Division of Pediatric Hematology/Oncology at the University of Utah School of Medicine has an immediate opening for a Study Coordinator. The Study Coordinator will support multiple investigators and will have the opportunity to help with a variety of research projects. Working under the direction of a senior research coordinator or manager, the Study Coordinator supports administrative operations and coordination of human subjects’ research studies. The Study Coordinator will perform a variety of duties in accordance with specific instructions and established work procedures, typically under close supervision. The Study Coordinator will follow written and verbal instructions to accomplish assignments, sometimes of a routine and repetitive nature, and is expected to work collaboratively with research and clinical care teams. They will work with senior staff to coordinate technical and administrative details involved in research studies, as well as assist the Principal Investigator (PI) and senior staff in achieving study integrity and objectives. The ideal candidate should at a minimum demonstrate interest in and the ability to perform the essential tasks relevant to the conduction and coordination of division research activities. Training in study-specific areas will be provided. Qualified applicants will demonstrate the ability to manage multiple aspects of ongoing research studies, and to work cooperatively with others in a research team. Coordinates technical and administrative details involved in a clinical or research study. Assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures. The University of Utah offers a comprehensive benefits package including: Excellent health care coverage at affordable rates 14.2% retirement contributions that vest immediately Generous paid leave time 11 paid Holidays per year 50% tuition reduction for employee, spouse, and dependent children Flex spending accounts Free transit on most UTA services Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel Professional development opportunities Additional benefits information is available at www.hr.utah.edu/benefits

Requirements

• Bachelor’s degree in a related field, or equivalency (one year of education can be substituted for two years of related work experience) required.
• IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire and demonstrated human relations and effective communication skills are also required.
• This position is patient-sensitive and must fulfill all associated requirements.
• We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy.
• Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.
• Some departments may require IATA DGR training within six months.

Responsibilities

• Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor.
• Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines.
• Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety.
• Register patients on clinical trials utilizing the appropriate registration process determined by the study group.
• Prepare documents for each newly diagnosed patient to include protocol consent, eligibility and
• pre-treatment requirements.
• Organizes and prepares study related equipment and supplies. Assists other staff in enrollment preparation and completion, including preparation of consents and lab kits.
• Determines length of visits and coordinates related facility and equipment availability.
• Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor.
• Completes, audits, corrects CRFs, relays CRFs to sponsor.
• Enters information into databases, and prepares documentation for submissions as appropriate (redacting, etc.). May assist in data quality control projects.
• Attends and participates in Investigator and staff meetings. Assists team with specific study assignments and timelines.
• Complete study related follow-ups and related patient or family contact as necessitated by protocol.
• Maintains documents as required by FDA guidelines.
• May interact with clinical care teams, patients, and families.
• May maintain contact with IRB and prepare and submit IRB documents.
• May ensure proper collection, processing and shipment of specimens.
• May perform functions required of the Clinical Research Assistant as necessary.
• Other duties as assigned by supervisor.

Benefits

• Excellent health care coverage at affordable rates
• 14.2% retirement contributions that vest immediately
• Generous paid leave time
• 11 paid Holidays per year
• 50% tuition reduction for employee, spouse, and dependent children
• Flex spending accounts
• Free transit on most UTA services
• Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
• Professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees