PS Clinical Research Coord - Salt Lake City, United States - University of Utah

Description

Bookmark this Posting | Print Preview | Apply for this Job

Announcement

Details

Open Date 05/03/2024 Requisition Number PRN38454B Job Title PS Clinical Research Coord Working Title PS Clinical Research Coord Job Grade E FLSA Code Administrative Patient Sensitive Job Code? Yes Standard Hours per Week 40 Full Time or Part Time? Full Time Shift Day Work Schedule Summary

Monday through Friday, 8:00 AM to 5:00 PM.

VP Area U of U Health - Academics Department Pediatric Administration Location Campus City Salt Lake City, UT Type of Recruitment External Posting Pay Rate Range $47,650 - $68,349 Close Date Open Until Filled Yes Job Summary

The Division of Hematology-Oncology in the Department of Pediatrics, University of Utah School of Medicine, has an immediate opening for a Clinical Research Coordinator.

The Clinical Research Coordinator will support multiple principal investigators and will have the opportunity to help with a variety of research projects including investigator-initiated trials (IIT) and a pediatric cancer biorepository study.

Working under the direction of a research manager, the Clinical Research Coordinator supports administrative operations and coordination of human subjects' and non-human subjects' research studies, such as retrospective studies and behavioral research projects.

The Clinical Research Coordinator assist Principal Investigators in all IRB and regulatory submissions and clinical coordination specific to protocol.

Duties include coordination of implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives.

The Clinical Research Coordinator oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.

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

Responsibilities

Essential Functions

• Recruit study subjects and ensure that all eligibility parameters are met. Ensure that informed consent is obtained prior to patient enrollment.
• Enroll patients in the biorepository utilizing the appropriate registration process and complete relevant data entry.
• Prepare documents for each newly diagnosed patient to include protocol consent, eligibility and pre-treatment requirements.
• Communicate process to obtain pathology and/or biology specimens and radiological imaging as required by protocol. Coordinate the submission of specimens with Primary Children's Hospital and Huntsman Cancer Institute laboratories according to protocol guidelines and shipping regulations.
• Maintain protocols by ensuring that new protocols, amendments and closures are up to date.
• Assist physician investigator with communications to the various study chairs or group office as needed. Provide feedback to medical team on quality assurance issues, protocol violations and documentation issues.
• Ensures appropriate research-related charges are routed correctly for payment processing.
• Prepare all necessary documents for an Institutional Audit and/or site visit Peer Review
• Provides cross-coverage as needed to ensure that the work requirements are met. Attends to other duties as assigned by supervisor.
• Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
• Assist principal investigators with preparing IRB protocols for submission and editing grant proposal submissions and maintenance of regulatory documents.
• Assist in survey design, development, and implementation via REDCap.
• Support in literature reviews for grant proposal, manuscripts, and IRB protocol submissions.
• Participate in research consultations with faculty, follow through on research tasks.

Additional Functions

The Clinical Research Coordinator will also perform these functions in conjunction with existing staff and may provide cross coverage of these functions with other staff members:

• Monitors enrollment and initiates strategies to promote participant compliance and ensuring protocol requirements are met. Coordinates and performs responsibilities related to research participants including screening subjects, scheduling visits, obtaining informed consent, answering inquiries, overseeing study visits, and acting as a liaison between participants and study-related parties.
• Will administer psychological measures (e.g., NIH Toolbox Cognition Battery).
• Will complete data entry and management and assist with data analysis.
• Recognizes, tracks, and reports adverse events and protocol deviations.
• Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
• Coordinates with physicians to provide information regarding available research projects.
• Will have regular contact with patients and families who are on study.
• Assists in the development of departmental quality assurance practices and standard operating procedures.

Problem Solving

The incumbent decides how to best accomplish the daily requirements of various study objectives, prioritizes and delegates workload and establishes systems needed to achieve specific study goals.

Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved.

The incumbent functions independently under minimal supervision, following COG, FDA, Good Clinical Practice, IRB, NIH, NCI, NSF and/or other regulatory agency guidelines and seeking council from the Principal Investigator as necessary.

The incumbent is expected to closely monitor use of experimental equipment and drugs.

Because some subjects referred to participate on a research study have no other option for recovery, the incumbent must be aware of the subject's condition, well informed in the use of study material (devices, equipment, etc.) and conscientious in his/her analysis of appropriate actions.

The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed.

Comments

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.

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.

Minimum Qualifications

Bachelors degree in a health sciences or related field or equivalency (one year of education can be substituted for two years of related work experience) with two 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.

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.

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

Preferences Type Benefited Staff Special Instructions Summary Additional Information

The University is a participating employer with Utah Retirement Systems ("URS").

Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work).

Contact Human Resources at for information.

Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS' post-retirement rules and restrictions.

Please contact Utah Retirement Systems at or or University Human Resource Management at if you have questions regarding the post-retirement rules.

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

The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.

All qualified individuals are strongly encouraged to apply. Veterans' preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.

The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran's status.

The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106.

The requirement not to discriminate in education programs or activities extends to admission and employment.

Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.

To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action (OEO/AA).

More information, including the Director/Title IX Coordinator's office address, electronic mail address, and telephone number can be located at:

Online reports may be submitted at

This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses.

They also provide information about safety and security-related services offered by the University of Utah.

A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.

Posting Specific Questions

Required fields are indicated with an asterisk (*).

• Do you have a related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)
• Yes
• No
• Please indicate the number of years of professional research experience that you have:
• Less than 1 year
• 1 year or more, but less than 2 years
• 2 year or more, but less than 4 years
• 4 years or more, but less than 6 years
• 6 years or more
• Do you have a working knowledge of Good Clinical Practices, FDA, HIPAA, and IRB regulations?
• Have knowledge in all of these areas
• Have knowledge in some of these areas, but not all
• No

previous knowledge in these areas

Applicant Documents

Required Documents

• Resume

Optional Documents

• Cover Letter
• Appropriate discharge document (such as a DD-21- Member Copy 4) - Veteran Only - Call
• Addendum to the University of Utah - Veteran Only - Call after submission