PS Clinical Research Coord Sr. - University of Utah
Salt Lake City, UT
About the Job
Details
Open Date 08/01/2024
Requisition Number PRN39403B
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 – Friday, 8:00 AM – 5:00 PM.
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 - $84,249
Close Date
Job Summary
Job Summary
The Division of Pediatric Hematology/Oncology at the University of Utah School of Medicine has an immediate opening for a Sr. Clinical Research Coordinator (Sr. CRC ). The incumbent coordinates complex clinical trial activities and plays a critical role in the conduct of multiple research studies for the treatment of pediatric cancers. The Sr. CRC assists the clinical trials process by registering patients for clinical studies, assessing eligibility criteria, maintaining current study documents, and assuring that all quality assurance measures are maintained within the protocol/study. The Sr. CRC . assists the Principal Investigator in all IRB and regulatory submissions and clinical coordination specific to protocol. They coordinate the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. The Sr. CRC 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:
+ Excellenthealth care coverageat affordable rates
+ 14.2% retirement contributionsthat vest immediately
+ Generouspaid leave time
+ 11 paid Holidaysper year
+ 50% tuition reductionfor employee, spouse, and dependent children
+ Flex spending accounts
+ Free transiton 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 atwww.hr.utah.edu/benefits
Responsibilities
Essential Functions
1. Oversees, assesses, and ensures participant safety and strict protocol implementation/adherence; oversees compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.
2. In coordination with the Research Manager develops strategy and operational best practices for early phase clinical trials.
3. Analyzes study monitoring and operational reports to monitor production and data collection events; evaluates progress towards meeting required timelines and data collection tasks.
4. 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.
5. 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 or manager as necessary.
6. Implements procedures to prevent future events, including staff education and retraining.
7. Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
8. May prepare, submit or maintain IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence for early phase trials.
9. Assists in the selection and hiring process for study staff; mentors and trains new or junior research staff.
10. Process specimens as required by study protocols, including after hours support. May require the need train other team members in these processes.
11. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
12. Develops training and staff certification materials, procedures and requirements. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study.
13. Helps develop applicable data management queries and oversees data cleaning activities.
14. Evaluates new protocols for feasibility and workflow considerations.
15. Thoroughly reviews study protocols and maps process and data flow to predict areas of vulnerability. Identifies, recommends and implements solutions to address such vulnerabilities in specific trials and across the team’s study portfolio.
16. Assists in the development of case report forms.
17. Develops QA/QC processes and conducts quality control activities (field/study visits, data queries).
18. Works with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs.
19. Helps to develop standard operating procedures.
20. Compiles information for grant applications.
21. Participates in abstract and manuscript preparation.
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
Department Specific Preferences
+ Working knowledge of pediatric hematology/oncology clinical trials
+ Laboratory experience processing tissue samples
+ Credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), or other related certification.
_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 08/01/2024
Requisition Number PRN39403B
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 – Friday, 8:00 AM – 5:00 PM.
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 - $84,249
Close Date
Job Summary
Job Summary
The Division of Pediatric Hematology/Oncology at the University of Utah School of Medicine has an immediate opening for a Sr. Clinical Research Coordinator (Sr. CRC ). The incumbent coordinates complex clinical trial activities and plays a critical role in the conduct of multiple research studies for the treatment of pediatric cancers. The Sr. CRC assists the clinical trials process by registering patients for clinical studies, assessing eligibility criteria, maintaining current study documents, and assuring that all quality assurance measures are maintained within the protocol/study. The Sr. CRC . assists the Principal Investigator in all IRB and regulatory submissions and clinical coordination specific to protocol. They coordinate the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. The Sr. CRC 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:
+ Excellenthealth care coverageat affordable rates
+ 14.2% retirement contributionsthat vest immediately
+ Generouspaid leave time
+ 11 paid Holidaysper year
+ 50% tuition reductionfor employee, spouse, and dependent children
+ Flex spending accounts
+ Free transiton 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 atwww.hr.utah.edu/benefits
Responsibilities
Essential Functions
1. Oversees, assesses, and ensures participant safety and strict protocol implementation/adherence; oversees compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.
2. In coordination with the Research Manager develops strategy and operational best practices for early phase clinical trials.
3. Analyzes study monitoring and operational reports to monitor production and data collection events; evaluates progress towards meeting required timelines and data collection tasks.
4. 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.
5. 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 or manager as necessary.
6. Implements procedures to prevent future events, including staff education and retraining.
7. Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
8. May prepare, submit or maintain IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research correspondence for early phase trials.
9. Assists in the selection and hiring process for study staff; mentors and trains new or junior research staff.
10. Process specimens as required by study protocols, including after hours support. May require the need train other team members in these processes.
11. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
12. Develops training and staff certification materials, procedures and requirements. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study.
13. Helps develop applicable data management queries and oversees data cleaning activities.
14. Evaluates new protocols for feasibility and workflow considerations.
15. Thoroughly reviews study protocols and maps process and data flow to predict areas of vulnerability. Identifies, recommends and implements solutions to address such vulnerabilities in specific trials and across the team’s study portfolio.
16. Assists in the development of case report forms.
17. Develops QA/QC processes and conducts quality control activities (field/study visits, data queries).
18. Works with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs.
19. Helps to develop standard operating procedures.
20. Compiles information for grant applications.
21. Participates in abstract and manuscript preparation.
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
Department Specific Preferences
+ Working knowledge of pediatric hematology/oncology clinical trials
+ Laboratory experience processing tissue samples
+ Credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), or other related certification.
_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.
Source : University of Utah
