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PS Clinical Research Coord Sr.

Employer
University of Utah
Location
Salt Lake City, UT
Closing date
Jan 15, 2022

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Sector
Other
Organization Type
Corporate
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Announcement Open Date 11/15/2021
Requisition Number PRN28490B
Job Title PS Clinical Research Coord Sr.
Working Title PS Clinical Research Coord Sr.
Job Grade F
FLSA Code Administrative
Patient Sensitive Job Code? Yes
Standard Hours per Week 40 hours
Full Time or Part Time? Full Time
Shift Day
Work Schedule SummaryFull time.
VP Area President
Department 01188 - HCI Molec Img Prog Operations
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $47,600 - $90,400
Close Date
Open Until Filled Yes
Job SummaryCoordinates complex clinical trial activities and plays a critical role in the conduct of multiple research studies.

ResponsibilitiesEssential Functions

1. In collaboration with the Principal Investigator, oversees the recruitment of study subjects and ensures that all eligibility parameters are met. Ensures that informed consent is obtained prior to patient enrollment.
2. Registers patients on clinical trials utilizing the appropriate registration process determined by the study group. Discusses the study with subject and obtains informed consent; schedules assessments/visits; assures study visits and tests are done at appropriate time intervals.
3. Prepares packets for each newly diagnosed patient to include protocol consent, eligibility and
imaging study requirements.
4. Maintains regulatory submission and oversight of Investigator-initiated oncology clinical trial portfolio.
5. Supports all aspects of regulatory compliance for investigational new drug (IND) radiopharmaceuticals including submissions to the Food and Drug Administration (FDA) and local Institutional Review Board (IRB)
6. Facilitate and ensure compliance to national reporting guidelines including the Clinical Trials Reporting Program (CTRP) and ClinicalTrials.gov.
7. Oversee the preparation of protocol amendments, safety reports, IND annual reports, and IRB continuing review submissions
8. Coordinate and implement quality control and compliance of investigator initiated and industry sponsored studies.
9. Support the development and drafting investigator-initiated research study protocols through creation of Informed Consent Forms documents and assisting in protocol development and maintenance.
10. Initiate strategies that increase participant enrollment to meet study objectives and goals.
11. Serves as reference point of contact to investigators and study teams regarding all aspects of IND preparation/maintenance.
12. Review all HCI clinical trials for imaging assessment requirements and present findings to FAR Committee.
13. Serve as central contact for coordination of CQCI tumor imaging response assessments.
14. 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.15. Assist in contract preparation of trials; Develop study budgets; monitor and billing; negotiate payment schedule and fees with sponsor.16. Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.17. Implement procedures to prevent future events, including staff education and retraining18. Represent the research program at meetings, national and international research consortia.19. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.20. Develop training and staff certification materials, procedures and requirements. Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study. Oversee and train team members across the entire spectrum of research studies to include, but not limited to: protocol requirements, schedule of visits, recruitment plan, execution of research plan, collecting adverse event information, maintaining study subject documentation. Maintain records and other documentation of training.21. Determine subject population availability, develop recruitment, informed consents and screening materials; help develop survey and study data collection instruments22. Develops QA/QC processes and conduct quality control activities (field/study visits, data queries)23. Helps to develop standard operating procedures24. Compiles information for grant applications25. Participates in abstract and manuscript preparation.Incumbent is responsible for overseeing regulatory compliance of clinical trials and maintenance of radiopharmaceuticals INDs including preparation for regulatory audits by developing, monitoring and updating quality controls and recommending actions to maintain compliance. This position is the expert regarding regulatory agency standards governing clinical trials for the CQCI and is responsible for overseeing the subject enrollment, imaging assessments, and all related reporting requirements. This position also negotiates with University research committees and sponsors to ensure full compliance and communication. Representative challenges of this position include assessing process shortfalls, and developing effective safeguards to reduce risk. 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 FDA, Good Clinical Practice, IRB, NIH, NCI, NSF and/or other regulatory agency guidelines and seeking council from the Principal Investigator as necessary.Comments Work Environment and Level of Frequency that may be required: Nearly Continuously: Office environment.Seldom: Infectious disease, body fluids (e.g., blood or urine collection), radioactive materials (e.g., PET radiopharmaceuticals) 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.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.
Huntsman Cancer Institute ( HCI ) is an Equal Opportunity Employer committed to hiring individuals whose merit and experience promote a diverse, inclusive, anti-racist workforce and culture. Each employee has a unique background and life experience. We believe that maximizing diversity fuels the success of our organization. In your cover letter or during your interview, we invite you to share how your background, beliefs, and experience will prepare you to be effective in working in an environment that values diversity and is committed to equity, diversity, and inclusion. Learn more about HCI's commitments at huntsmancancer.org/edi and/or contact HCI's Office of Equity, Diversity, and Inclusion.
Minimum QualificationsBachelor's degree in a health science or related field or equivalency; plus, 4 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.

Care is appropriate to the population served

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
PreferencesBachelor's degree in a health science or related field or equivalency; plus, 3 years professional clinical research experience and completion SOCRA Certification within one year of hire.
Type Benefited Staff
Special Instructions Summary
Additional Information The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.
Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are 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:
Director/ Title IX Coordinator

Office of Equal Opportunity and Affirmative Action ( OEO /AA)

135 Park Building

Salt Lake City, UT 84112

801-581-8365

oeo@utah.edu

Online reports may be submitted at oeo.utah.edu

To inquire about this posting, email: employment@utah.edu or call 801-581-2300.

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 (801) 581-7447 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 (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 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.
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