PS Study Coordinator

The University of Utah•Salt Lake, UT

16d•Onsite

About The Position

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. Oversees clinical trials and studies related to Pediatric Neuromuscular research in rare diseases including Muscular Dystrophy, Spinal Muscular Atrophy, Facioscapular Humeral Dystrophy, and more. Works with a team of collaborative coordinators all focused on the same disorders within the Division of Pediatric Neurology. 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 Responsibilities Disclaimer This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It 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. Essential Functions 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. Determines length of visits and coordinates related facility and equipment availability. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor. 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. Assists scheduling and running patient visits. Maintains documents as required by FDA guidelines. 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. Problem Solving Incumbents are responsible for coordinating the daily operations of their assigned research team, coordinating the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives. Comments Work Environment and Level of Frequency that may be required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting, hearing, listening, talking. Often: Repetitive hand motion (such as typing), walking. Seldom: Bending, reaching overhead. The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.

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.
Determines length of visits and coordinates related facility and equipment availability.
Reports and tracks adverse events (AE).
Reports serious AEs to IRB and sponsor.
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.
Assists scheduling and running patient visits.
Maintains documents as required by FDA guidelines.
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.

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
Additional benefits information is available at www.hr.utah.edu/benefits