- Oversees compliance to protocol for multiple Principal Investigators; manages quality control, completion, and submission of study related documentation; prepares reports for organizations and agencies.
- Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
- Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs 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.
- 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.
- Prepares, submits, and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
- Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
- Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
- Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
- Assists the Principal Investigator(s) in the development of study protocols.
- 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
- Resume
- Cover Letter
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Clinical Research Coordinator - Salt Lake City, United States - University of Utah
Description
Bookmark this Posting | Print Preview | Apply for this JobAnnouncement
Details
Open Date 01/05/2024 Requisition Number PRN37340B Job Title Clinical Research Coordinator Working Title Clinical Research Coordinator Job Grade E FLSA Code Administrative Patient Sensitive Job Code? No Standard Hours per Week 40 Full Time or Part Time? Full Time Shift Day Work Schedule Summary
Monday - Friday, The Clinical Research Coordinator will be mostly based at the SOD clinics, with travel between sites.
VP Area U of U Health - Academics Department SOD - EDUCATION Location Campus City Salt Lake City, UT Type of Recruitment External Posting Pay Rate Range $50, ,000 Close Date Open Until Filled No Job Summary
The School of Dentistry Office of Research has an immediate opening for a Clinical Research Coordinator.
This position coordinates the implementation, quality control and completion of research studies while assisting the Principal Investigator(s) in determining and accomplishing study objectives.
This employee will contribute to the oversight of research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.
This position may have an optional hybrid schedule depending on the workload and responsibilities.
As a member of the School of Dentistry team you are expected to form positive and productive relationships with peers, students and leadership to support the mission, vision, values, and PROMISE standards of the organization.
You are expected to encourage and foster a supportive, anti-racist, equitable, and inclusive environment for our patients, students, faculty, staff, and the communities we serve.
ResponsibilitiesDisclaimer
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
The incumbent decides how to best accomplish the daily requirements of various study objectives, prioritizes, and establishes systems needed to achieve specific study goals.
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 and/or Office of Research 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 subjects' 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 for organizing coverage when not present to ensure protocol requirements are followed.Comments
Work Environment and Level of Frequency that may be required:
Nearly Continuously:
Office and Clinic environment.
This position requires travel between the School of Dentistry Clinics. Employee must have a valid driver's license and reliable transportation that is not public transportation.
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
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.
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 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.
Experience working in university and patient care settings with research faculty.
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.
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).
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.
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