University of Utah
Clinical Research Coord
University of Utah, Salt Lake City, Utah, United States, 84193
Details
Open Date 11/21/2024
Requisition Number PRN40384B
Job Title PS Clinical Research Coord
Working Title 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
VP Area President
Department 02059 - HCI Popul Sci Trials Office
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 39300 to 72700
Close Date 02/19/2025
Priority Review Date
Job Summary
The Population Sciences Trials Office at the Huntsman Cancer Institute has an immediate opening for a Clinical Research Coordinator. The coordinator will assist the Principal Investigator(s) in coordinating the implementation, quality control and completion of research studies while- assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. This work may include supporting investigator-initiated studies and sponsored projects.
The Population Sciences Trials Office ( PSTO ) supports Investigators conducting observational and behavioral intervention studies aimed at preventing cancer in different populations and/or at improving outcomes and the quality of life among those diagnosed with cancer. This coordinator will work with a collaborative team of study support staff under the direction of the PSTO research manager to support the Principal Investigator’s research objectives.
Depending on study needs, employees may have a hybrid work schedule, working both remotely as well as on-site after the training period is complete. Employees may need to provide their own home office space, internet connection, telephone, and have the ability to work independently.
This position is eligible for university benefits. These benefits include:
Medical-dental-wellness coverage: https://www.hr.utah.edu/index.php
An immediately vested 14.2% of salary employer contribution to retirement (401a): https://benefits.utah.edu/university-funded-retirement-accounts/
Paid leave: https://www.hr.utah.edu/benefits/paidLeave.php
Paid holidays: https://www.hr.utah.edu/benefits/holiday.php
Tuition assistance for employees and family: https://www.hr.utah.edu/benefits/tuition.php
Free UTA transport pass: https://commuterservices.utah.edu/uta/
See details about these benefits and others at: https://www.hr.utah.edu/benefits/
Total Compensation Calculator https://www.hr.utah.edu/comp/totalcomp.php
HuntsmanCancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values cancer-related health equity, and inclusion as integral to our guiding principle to serve our patients and their communities, and our commitment to foster a culture of belonging for all within our organization.
In your cover letter or during your interview process, we invite you to share how your personal and professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position.
Learn more here
Responsibilities
Responsibilities:
This position will coordinate the technical and administrative details involved in a clinical or research study in the following ways:
Coordinating with Principal Investigators and other study staff to carry out research objectives from protocol planning and implementation to quality control and completion.
Creating and maintaining data, regulatory, and operational documentation for studies.
Working with other study coordinators, as well as biospecimen, data, regulatory, and financial support teams to develop and manage study resources and records.
Working with clinic staff to integrate study activities into clinic flow.
Oversee research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.
Monitors budget expenses and billing for allied services.
Providing back-up team coverage when needed.
Essential Functions
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.
Schedules and completes participant study visits and study procedures per protocol
Collects, processes, and ships specimens per the study protocol
Schedules and participates in site initiation visits, monitoring visits, and close-out visits
Performs data entry, assurance, reporting activities and maintains information in study databases
Reports and tracks deviations, adverse events (AE), and serious adverse events ( SAE ), as applicable
Acts as a liaison between sponsors and the study team, and develops operating processes and procedures, as applicable
Ensures regulatory requirements are met on research studies by maintaining and updating required regulatory documents
Prepares IRB new study submissions, amendments, and renewals IRB submission and maintenance and other regulatory and compliance activities
Represents the research program at meetings, national and international research consortia. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
Supervises, mentors and trains new or junior research staff.
Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
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.
The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed.
This job description 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.
Work Environment and Level of Frequency that may be required:
Nearly Continuously: Office environment.
Seldom: Infectious disease, oils ( there is air or skin exposure to oils or other cutting fluids).
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. 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
Experience with the IRB and ERICA
Experience with EPIC and electronic data capture systems, like REDCap
Experience in a healthcare setting or healthcare certification.
Ability to work as part of a team and also work independently.
Comfortable engaging with study participants in person, by phone, and virtually.
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 (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.
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: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
https://safety.utah.edu/safetyreport 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.
Open Date 11/21/2024
Requisition Number PRN40384B
Job Title PS Clinical Research Coord
Working Title 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
VP Area President
Department 02059 - HCI Popul Sci Trials Office
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 39300 to 72700
Close Date 02/19/2025
Priority Review Date
Job Summary
The Population Sciences Trials Office at the Huntsman Cancer Institute has an immediate opening for a Clinical Research Coordinator. The coordinator will assist the Principal Investigator(s) in coordinating the implementation, quality control and completion of research studies while- assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. This work may include supporting investigator-initiated studies and sponsored projects.
The Population Sciences Trials Office ( PSTO ) supports Investigators conducting observational and behavioral intervention studies aimed at preventing cancer in different populations and/or at improving outcomes and the quality of life among those diagnosed with cancer. This coordinator will work with a collaborative team of study support staff under the direction of the PSTO research manager to support the Principal Investigator’s research objectives.
Depending on study needs, employees may have a hybrid work schedule, working both remotely as well as on-site after the training period is complete. Employees may need to provide their own home office space, internet connection, telephone, and have the ability to work independently.
This position is eligible for university benefits. These benefits include:
Medical-dental-wellness coverage: https://www.hr.utah.edu/index.php
An immediately vested 14.2% of salary employer contribution to retirement (401a): https://benefits.utah.edu/university-funded-retirement-accounts/
Paid leave: https://www.hr.utah.edu/benefits/paidLeave.php
Paid holidays: https://www.hr.utah.edu/benefits/holiday.php
Tuition assistance for employees and family: https://www.hr.utah.edu/benefits/tuition.php
Free UTA transport pass: https://commuterservices.utah.edu/uta/
See details about these benefits and others at: https://www.hr.utah.edu/benefits/
Total Compensation Calculator https://www.hr.utah.edu/comp/totalcomp.php
HuntsmanCancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values cancer-related health equity, and inclusion as integral to our guiding principle to serve our patients and their communities, and our commitment to foster a culture of belonging for all within our organization.
In your cover letter or during your interview process, we invite you to share how your personal and professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position.
Learn more here
Responsibilities
Responsibilities:
This position will coordinate the technical and administrative details involved in a clinical or research study in the following ways:
Coordinating with Principal Investigators and other study staff to carry out research objectives from protocol planning and implementation to quality control and completion.
Creating and maintaining data, regulatory, and operational documentation for studies.
Working with other study coordinators, as well as biospecimen, data, regulatory, and financial support teams to develop and manage study resources and records.
Working with clinic staff to integrate study activities into clinic flow.
Oversee research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.
Monitors budget expenses and billing for allied services.
Providing back-up team coverage when needed.
Essential Functions
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.
Schedules and completes participant study visits and study procedures per protocol
Collects, processes, and ships specimens per the study protocol
Schedules and participates in site initiation visits, monitoring visits, and close-out visits
Performs data entry, assurance, reporting activities and maintains information in study databases
Reports and tracks deviations, adverse events (AE), and serious adverse events ( SAE ), as applicable
Acts as a liaison between sponsors and the study team, and develops operating processes and procedures, as applicable
Ensures regulatory requirements are met on research studies by maintaining and updating required regulatory documents
Prepares IRB new study submissions, amendments, and renewals IRB submission and maintenance and other regulatory and compliance activities
Represents the research program at meetings, national and international research consortia. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
Supervises, mentors and trains new or junior research staff.
Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
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.
The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed.
This job description 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.
Work Environment and Level of Frequency that may be required:
Nearly Continuously: Office environment.
Seldom: Infectious disease, oils ( there is air or skin exposure to oils or other cutting fluids).
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. 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
Experience with the IRB and ERICA
Experience with EPIC and electronic data capture systems, like REDCap
Experience in a healthcare setting or healthcare certification.
Ability to work as part of a team and also work independently.
Comfortable engaging with study participants in person, by phone, and virtually.
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 (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.
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: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
https://safety.utah.edu/safetyreport 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.