University of Utah
PS Clinical Research Coord Sr.
University of Utah, Salt Lake City, Utah, United States, 84193
Details
Open Date 11/12/2024
Requisition Number PRN40305B
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
Full Time or Part Time? Full Time
Shift Day
Work Schedule Summary
Monday through Friday, 8:00 a.m. to 5:00 p.m. Occasionally requires alternative hours during evenings, weekends and holidays as needed.
VP Area U of U Health - Academics
Department 00848 - Pediatric Administration
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $47,600 to $84,249
Close Date 02/12/2025
Priority Review Date
Job Summary
Job Summary
The Division of Pediatric Cardiology at the University Of Utah School Of Medicine has an immediate opening for a Senior Clinical Research Coordinator to provide support to Principal Investigators within the Heart Center. This successful candidate will assist in facilitating the conduct of clinical research by performing research and clinical duties, providing protocol-driven patient care for complex clinical trial activities in compliance with guidelines set by governing agencies. Actual skills and responsibilities will vary according to the specific research project.
Additionally, the successful candidate for this position will be responsible for coordinating the implementation, quality control and completion of research studies while accomplishing study objectives and for maintaining compliance with guidelines set by government agencies. The person in this position will work with Heart Center Principal Investigators to conduct studies as assigned. Specific responsibilities include participation in protocol development, creating and piloting data collection forms, identification of potential subjects, interfacing with patients and families, obtaining informed consents, scheduling study visits and tests, supervising data collection, entering study data in databases, maintaining all regulatory documents, securing and ensuring proper handling of study samples, and distributing and maintaining documentation of patient incentives. Coordinators will use medical knowledge and clinical experience to perform multiple functions for this position, including but not limited to analyzing or evaluating clinical data, developing and implementing clinical workflows for studies/protocols, performing medical reviews, and training research coordinators throughout the network. The Research Senior Coordinator will have the opportunity to participate in the dissemination of results through abstract and manuscript production as appropriate.
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 https://benefits.utah.edu/
Responsibilities
Essential Functions
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.
Assists in development of study budgets; monitors budget expenses for allied services; maintains all billing, incentive, and reimbursement records.
Disseminates information about the protocol auxiliary personnel.
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.
Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.
Works with the Data Coordinating Center to monitor participant progression throughout study and conducts evaluation at pre-specified intervals and at end of study.
Creates and maintains a system to track data entry and audit for completeness, accuracy, and timeliness of data collection.
Recognizes, tracks and reports adverse events and protocol deviations.
Prepares for and coordinates site visits made by sponsors or federal agencies during the course of and at the close of the study.
Implement procedures to prevent future events, including staff education and retraining
Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence.
Develops and maintains patient databases, investigational logs and records of drugs administered and/or procedures followed.
Completes ongoing training on techniques of clinical research coordination and practices, FDA Good Clinical Practices ( GCP ), and clinical research standard operating procedures to ensure compliance with policy and procedure, research sponsors and Federal rules and regulations.
Assures proper laboratory samples are collected and shipped per study protocol and results are reported to the proper entities.
Coordinates with physicians to provide information regarding available research projects and to maintain a strong referral basis.
Assists the Principal Investigator in the development of study materials and protocols.
Represent the research program at meetings, national and international research consortia as determined by the Principal Investigator and Pediatric Heart Center Administrative Research Director.
Organizes the activities within the assigned grant proposals under the direction of the Principal Investigator.
Plays a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation accuracy of data collection, data recording and follow up.
Provides care received to research participants driven by study requirements and the collection of research data as well as clinical indications. Study procedures may include administration of investigational drugs and monitoring of side effects, performance of an experimental or investigational surgical or radiological procedure, detailed clinical assessment, for example.
Comments
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.
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
Bachelor’s degree in a health science or related field or equivalency (one year of education can be substituted for two years of related work experience); 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.
Preferences
Preferences
Registered nurse with research experience will be considered.
Prior experience in the pediatrics and/or cardiovascular clinical research areas.
Credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), or other related certification.
Experience with human subjects research, demonstrated human relations skills, and working knowledge of Good Clinical Practices, FDA , HIPPA ICH , and IRB regulations and regulatory compliance.
Must be a self-starter with exceptional organizational skills, ability to function independently, and attention to detail.
Excellent interpersonal and communications skills, both oral and written.
Proficiency in Microsoft Office, excel and the ability to learn new software programs.
IRB CITI Course for Human Subjects and CITI GCP or IATA DGR training are required within 3 weeks of hire.
Applicants will be screened according to 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 (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 11/12/2024
Requisition Number PRN40305B
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
Full Time or Part Time? Full Time
Shift Day
Work Schedule Summary
Monday through Friday, 8:00 a.m. to 5:00 p.m. Occasionally requires alternative hours during evenings, weekends and holidays as needed.
VP Area U of U Health - Academics
Department 00848 - Pediatric Administration
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $47,600 to $84,249
Close Date 02/12/2025
Priority Review Date
Job Summary
Job Summary
The Division of Pediatric Cardiology at the University Of Utah School Of Medicine has an immediate opening for a Senior Clinical Research Coordinator to provide support to Principal Investigators within the Heart Center. This successful candidate will assist in facilitating the conduct of clinical research by performing research and clinical duties, providing protocol-driven patient care for complex clinical trial activities in compliance with guidelines set by governing agencies. Actual skills and responsibilities will vary according to the specific research project.
Additionally, the successful candidate for this position will be responsible for coordinating the implementation, quality control and completion of research studies while accomplishing study objectives and for maintaining compliance with guidelines set by government agencies. The person in this position will work with Heart Center Principal Investigators to conduct studies as assigned. Specific responsibilities include participation in protocol development, creating and piloting data collection forms, identification of potential subjects, interfacing with patients and families, obtaining informed consents, scheduling study visits and tests, supervising data collection, entering study data in databases, maintaining all regulatory documents, securing and ensuring proper handling of study samples, and distributing and maintaining documentation of patient incentives. Coordinators will use medical knowledge and clinical experience to perform multiple functions for this position, including but not limited to analyzing or evaluating clinical data, developing and implementing clinical workflows for studies/protocols, performing medical reviews, and training research coordinators throughout the network. The Research Senior Coordinator will have the opportunity to participate in the dissemination of results through abstract and manuscript production as appropriate.
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 https://benefits.utah.edu/
Responsibilities
Essential Functions
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.
Assists in development of study budgets; monitors budget expenses for allied services; maintains all billing, incentive, and reimbursement records.
Disseminates information about the protocol auxiliary personnel.
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.
Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.
Works with the Data Coordinating Center to monitor participant progression throughout study and conducts evaluation at pre-specified intervals and at end of study.
Creates and maintains a system to track data entry and audit for completeness, accuracy, and timeliness of data collection.
Recognizes, tracks and reports adverse events and protocol deviations.
Prepares for and coordinates site visits made by sponsors or federal agencies during the course of and at the close of the study.
Implement procedures to prevent future events, including staff education and retraining
Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence.
Develops and maintains patient databases, investigational logs and records of drugs administered and/or procedures followed.
Completes ongoing training on techniques of clinical research coordination and practices, FDA Good Clinical Practices ( GCP ), and clinical research standard operating procedures to ensure compliance with policy and procedure, research sponsors and Federal rules and regulations.
Assures proper laboratory samples are collected and shipped per study protocol and results are reported to the proper entities.
Coordinates with physicians to provide information regarding available research projects and to maintain a strong referral basis.
Assists the Principal Investigator in the development of study materials and protocols.
Represent the research program at meetings, national and international research consortia as determined by the Principal Investigator and Pediatric Heart Center Administrative Research Director.
Organizes the activities within the assigned grant proposals under the direction of the Principal Investigator.
Plays a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation accuracy of data collection, data recording and follow up.
Provides care received to research participants driven by study requirements and the collection of research data as well as clinical indications. Study procedures may include administration of investigational drugs and monitoring of side effects, performance of an experimental or investigational surgical or radiological procedure, detailed clinical assessment, for example.
Comments
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.
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
Bachelor’s degree in a health science or related field or equivalency (one year of education can be substituted for two years of related work experience); 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.
Preferences
Preferences
Registered nurse with research experience will be considered.
Prior experience in the pediatrics and/or cardiovascular clinical research areas.
Credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), or other related certification.
Experience with human subjects research, demonstrated human relations skills, and working knowledge of Good Clinical Practices, FDA , HIPPA ICH , and IRB regulations and regulatory compliance.
Must be a self-starter with exceptional organizational skills, ability to function independently, and attention to detail.
Excellent interpersonal and communications skills, both oral and written.
Proficiency in Microsoft Office, excel and the ability to learn new software programs.
IRB CITI Course for Human Subjects and CITI GCP or IATA DGR training are required within 3 weeks of hire.
Applicants will be screened according to 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 (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.