Clinical Trial Activation Administrator - University of Utah
Salt Lake City, UT
About the Job
Details
Open Date 09/20/2024
Requisition Number PRN39905B
Job Title PS Project Administrator
Working Title Clinical Trial Activation Administrator
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
VP Area President
Department 01167 - HCI Clinical Trials Operations
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47600 to 90400
Close Date
Open Until Filled No
Job Summary
The Huntsman Cancer Institute Clinical Trials Office ( CTO ) is hiring a Project Administrator to oversee activation activities for oncology clinical trials conducted at Huntsman Cancer Institute. Responsible for evaluating new clinical trial opportunities for HCI with faculty principal investigators and clinical trial research managers and administrators. This will include facilitating and building strategic relationships with research partners; facilitation, tracking and execution of confidentiality agreements, completing feasibility questionnaires, conducting pre-study site visits, and tracking of the opportunities and outcomes. Serve as primary liaison with sponsors and vendors; manage deliverables to clinical trial research multi-disciplinary teams; oversee project agreements; and nurture internal & external partnerships.
Minimum Qualifications
Bachelor’s degree in a health sciences or related field with two years professional research experience in human subject research. Preferred Oncology Clinical Trials Experience. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.
+ Knowledge of FDA regulations relevant to drugs, devices, biologics
+ Previous working knowledge and experience with the pharmaceutical sponsors and contract research organizations
+ Attention to detail with excellent analytical and problem-solving skills
+ Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology in oncology
+ Ability to manage multiple tasks and set priorities and meet deadlines
+ Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment
+ Excellent organizational and communication skills
+ Skilled in Microsoft Office
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
_Huntsman Cancer 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._
_In your cover letter or during your interview process, we invite you to share how your 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._
Responsibilities
1. Oversees coordination and activation workflow to ensure appropriate timelines are met.
2. Execution of confidentiality agreement for all clinical trial opportunities
3. Maintains trial activation resources, brochures and start-up materials for activation process
4. Completes feasibility questionnaires for clinical trials presented to the Clinical Trials Office
5. Primary liaison with internal or external clients, sponsors, or partners for assigned studies, projects, or programs. Lead contact for all project matters; understand and manage contractual and organizational client expectations; nurture client relationship and needs. Provide to the sponsor regular reports on project status, certain metrics, and issues.
6. Manage project deliverables. Supervise progress by keeping close metrics, including but not limited to time and quality. Prepare and lead presentations of internal project status to upper management, disease group leaders and associated teams. Be accountable for follow-up on action items. Take the initiative in identifying, resolving, or escalating issues.
7. Represent the Clinical Trials Office and HCI Clinical Trial Research Group meetings
8. Complete intake Clinical Trial Research Group new study review and prioritization forms.
9. Submit trial packages to the Feasibility Administrative Review & PRMC committees and follow-up on action items to achieve approval in those areas.
10. Liaise with the Office of Sponsored Projects and CTO Finance Pre-Award team to ensure appropriate and timely execution of CDAs, CTAs and study budgets. Assist in scheduling calls and supporting negotiations in these areas.
11. In cooperation with research managers and administrators, organize and actively participate in sponsor site visits.
12. Work closely with and mentor new members of the clinical project management team.
13. Serve as an internal liaison to bridge trials from activation to maintenance.
14. Act as a liaison between study sponsors, HCI investigators and the Clinical Trials Office by evaluating problems and providing solutions.
15. Understand and act within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the conduct of clinical research.
16. Promote a positive work environment that is maintained through open and effective communication
17. Serve as first point of contact for potential outside CROs and sponsors. Be the face of the HCI CTO .
18. Establish and foster strong relationships and interactions with HCI investigators, study sponsors and the Clinical trials office personnel.
19. Ensure high quality of data and metrics to study sponsors and research teams.
20. Fully oversee process and efficiency improvements in the trial activation area.
21. Coordinates with referring physicians to provide information regarding available research projects.
22. Must be able to work independently and have strong communication and human relations skills.
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 typically required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.
Minimum Qualifications
Bachelor’s degree in Business Administration, Accounting, or a related field, or equivalency (one year of education can be substituted for two years of related work experience); four years of progressively more responsible related experience; and demonstrated human relation and effective communications skills required. A related Master’s degree preferred.
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.
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 09/20/2024
Requisition Number PRN39905B
Job Title PS Project Administrator
Working Title Clinical Trial Activation Administrator
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
VP Area President
Department 01167 - HCI Clinical Trials Operations
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47600 to 90400
Close Date
Open Until Filled No
Job Summary
The Huntsman Cancer Institute Clinical Trials Office ( CTO ) is hiring a Project Administrator to oversee activation activities for oncology clinical trials conducted at Huntsman Cancer Institute. Responsible for evaluating new clinical trial opportunities for HCI with faculty principal investigators and clinical trial research managers and administrators. This will include facilitating and building strategic relationships with research partners; facilitation, tracking and execution of confidentiality agreements, completing feasibility questionnaires, conducting pre-study site visits, and tracking of the opportunities and outcomes. Serve as primary liaison with sponsors and vendors; manage deliverables to clinical trial research multi-disciplinary teams; oversee project agreements; and nurture internal & external partnerships.
Minimum Qualifications
Bachelor’s degree in a health sciences or related field with two years professional research experience in human subject research. Preferred Oncology Clinical Trials Experience. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.
+ Knowledge of FDA regulations relevant to drugs, devices, biologics
+ Previous working knowledge and experience with the pharmaceutical sponsors and contract research organizations
+ Attention to detail with excellent analytical and problem-solving skills
+ Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology in oncology
+ Ability to manage multiple tasks and set priorities and meet deadlines
+ Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment
+ Excellent organizational and communication skills
+ Skilled in Microsoft Office
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
_Huntsman Cancer 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._
_In your cover letter or during your interview process, we invite you to share how your 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._
Responsibilities
1. Oversees coordination and activation workflow to ensure appropriate timelines are met.
2. Execution of confidentiality agreement for all clinical trial opportunities
3. Maintains trial activation resources, brochures and start-up materials for activation process
4. Completes feasibility questionnaires for clinical trials presented to the Clinical Trials Office
5. Primary liaison with internal or external clients, sponsors, or partners for assigned studies, projects, or programs. Lead contact for all project matters; understand and manage contractual and organizational client expectations; nurture client relationship and needs. Provide to the sponsor regular reports on project status, certain metrics, and issues.
6. Manage project deliverables. Supervise progress by keeping close metrics, including but not limited to time and quality. Prepare and lead presentations of internal project status to upper management, disease group leaders and associated teams. Be accountable for follow-up on action items. Take the initiative in identifying, resolving, or escalating issues.
7. Represent the Clinical Trials Office and HCI Clinical Trial Research Group meetings
8. Complete intake Clinical Trial Research Group new study review and prioritization forms.
9. Submit trial packages to the Feasibility Administrative Review & PRMC committees and follow-up on action items to achieve approval in those areas.
10. Liaise with the Office of Sponsored Projects and CTO Finance Pre-Award team to ensure appropriate and timely execution of CDAs, CTAs and study budgets. Assist in scheduling calls and supporting negotiations in these areas.
11. In cooperation with research managers and administrators, organize and actively participate in sponsor site visits.
12. Work closely with and mentor new members of the clinical project management team.
13. Serve as an internal liaison to bridge trials from activation to maintenance.
14. Act as a liaison between study sponsors, HCI investigators and the Clinical Trials Office by evaluating problems and providing solutions.
15. Understand and act within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the conduct of clinical research.
16. Promote a positive work environment that is maintained through open and effective communication
17. Serve as first point of contact for potential outside CROs and sponsors. Be the face of the HCI CTO .
18. Establish and foster strong relationships and interactions with HCI investigators, study sponsors and the Clinical trials office personnel.
19. Ensure high quality of data and metrics to study sponsors and research teams.
20. Fully oversee process and efficiency improvements in the trial activation area.
21. Coordinates with referring physicians to provide information regarding available research projects.
22. Must be able to work independently and have strong communication and human relations skills.
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 typically required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.
Minimum Qualifications
Bachelor’s degree in Business Administration, Accounting, or a related field, or equivalency (one year of education can be substituted for two years of related work experience); four years of progressively more responsible related experience; and demonstrated human relation and effective communications skills required. A related Master’s degree preferred.
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.
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
