PS Clinical Research Coord Job at University of Utah
The ColoCare Study at the Huntsman Cancer Institute (HCI) has an immediate opening for a Clinical Research Coordinator position. The ColoCare Study is a large, multisite, international cohort study of patients diagnosed with colorectal cancer, and includes 6 study sites in the United States and one in Germany. This is an exciting opportunity to be part of patient-oriented clinical research in colorectal cancer survivorship.
The applicant will coordinate research and administrative activities in support of the ColoCare Study. The position involves many diverse tasks, including collaboration with clinical staff and national/international study sites, development of new procedures and research instruments as needed, patient consenting and follow-up, specimen procurement, regulatory activities, carrying out moderately complex research assignments, assistance with grant writing, and study implementation.
Huntsman Cancer Institute ( HCI ) is an Equal Opportunity Employer committed to hiring individuals whose merit and experience promote a diverse, inclusive, anti-racist workforce and culture.
The applicant will coordinate research and administrative activities in support of the ColoCare Study. The position involves many diverse tasks, including collaboration with clinical staff and national/international study sites, development of new procedures and research instruments as needed, patient consenting and follow-up, specimen procurement, regulatory activities, carrying out moderately complex research assignments, assistance with grant writing, and study implementation.
Huntsman Cancer Institute ( HCI ) is an Equal Opportunity Employer committed to hiring individuals whose merit and experience promote a diverse, inclusive, anti-racist workforce and culture.
Each employee has a unique background and life experience. We believe that maximizing diversity fuels the success of our organization. In your cover letter or during your interview, we invite you to share how your background, beliefs, and experience will prepare you to be effective in working in an environment that values diversity and is committed to equity, diversity, and inclusion.
Learn more about HCI’s commitments at huntsmancancer.org/edi and/or contact HCI’s Office of Equity, Diversity, and Inclusion.
Responsibilities
The coordinator works under the direction of the Principal Investigator, the cohort-wide Scientific Coordinator, and the HCI site-specific Supervisor, consults with the team on project/study issues, and/or solicits guidance as necessary. Special skills and knowledge are applied in coordinating research and administrative activities and in carrying out research assignments. The coordinator will develop strong working relationships and maintain effective communication with study team members. The coordinator will increasingly oversee the work of the research assistant, students, and other study staff. S/he works independently with health care providers and patients and is responsible for organizing study logistics and study materials.
Essential Functions
1. Oversees and ensures strict protocol implementation/adherence; oversees compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.
Essential Functions
1. Oversees and ensures strict protocol implementation/adherence; oversees compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.
2. Implements protocol and assesses changes for compliance and subject safety, reviews inclusions/exclusion criteria; clarifies concerns and questions with Principal Investigator.
3. Monitors budget expenses and billing for allied services
4. Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining patient eligibility, 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.
3. Monitors budget expenses and billing for allied services
4. Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining patient eligibility, 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.
5. Contributes to work related to developing study questionnaires.
6. Recognizes, tracks, and reports adverse events and protocol deviations.
6. Recognizes, tracks, and reports adverse events and protocol deviations.
7. Analyzes study monitoring and operational reports to monitor production and data collection events; evaluates progress towards meeting required timelines and data collection tasks.
8. Prepares for and coordinates local study meetings, as well as cohort-wide meetings.
9. May represent the research program at meetings, national and international research consortia.
10. Prepares, submits, and maintains IRB, FDA, NCI, NIH, NSF, and/or other regulatory documents and research correspondence.
11. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
12. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
13. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed. Assists in limited data entry activities.
9. May represent the research program at meetings, national and international research consortia.
10. Prepares, submits, and maintains IRB, FDA, NCI, NIH, NSF, and/or other regulatory documents and research correspondence.
11. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
12. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
13. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed. Assists in limited data entry activities.
14. Ensures proper collection, processing, and shipment of specimens.
15. Assists the Principal Investigator, the Scientific Coordinator, and the HCI site-specific Supervisor in the development of study protocols.
15. Assists the Principal Investigator, the Scientific Coordinator, and the HCI site-specific Supervisor in the development of study protocols.
16. Assists with scientific manuscripts and grant writing.
17. Perform other responsibilities as required.
Problem Solving
The incumbent decides how to best accomplish the daily requirements of various study objectives, prioritizes and delegates workload, and establishes systems needed to achieve study goals. 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 decides how to best accomplish the daily requirements of various study objectives, prioritizes and delegates workload, and establishes systems needed to achieve study goals. 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.
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 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.
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
IRB CITI Course in the Protection of Human Research Subjects certificate obtained within six months of hire, demonstrated human relations and effective communication skills, and phlebotomy training are also strongly preferred. Phlebotomy training may be completed after hire.
Successful applicants will be able to demonstrate the ability for interacting effectively with patients and within the study team, as well as for interdisciplinary and international research and will be able to perform the essential job functions as outlined in the position description. S/he will enjoy performing a diversity of tasks, will have exceptional organizational skills, attention to detail, and has demonstrated excellent communication skills.
Proficiency in Microsoft Office and Excel.
Type
Benefited Staff
Special Instructions Summary
Additional Information
The University of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.
Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are 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:
Director/ Title IX Coordinator
Office of Equal Opportunity and Affirmative Action ( OEO /AA)
383 University Street, Level 1 OEO Suite
Salt Lake City, UT 84112
801-581-8365
oeo@utah.edu
Online reports may be submitted at oeo.utah.edu
For more information: https://www.utah.edu/nondiscrimination/
To inquire about this posting, email: employment@utah.edu or call 801-581-2300.
Office of Equal Opportunity and Affirmative Action ( OEO /AA)
383 University Street, Level 1 OEO Suite
Salt Lake City, UT 84112
801-581-8365
oeo@utah.edu
Online reports may be submitted at oeo.utah.edu
For more information: https://www.utah.edu/nondiscrimination/
To inquire about this posting, email: employment@utah.edu or call 801-581-2300.
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.
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.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
- * Do you have a related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)
- Yes
- No
- * Please indicate the number of years of professional research experience that you have:
- Less than 1 year
- 1 year or more, but less than 2 years
- 2 year or more, but less than 4 years
- 4 years or more, but less than 6 years
- 6 years or more
- Do you have any current relatives working in HCI?
(Open Ended Question)
- Which pronouns do you prefer that people use for you?
- She, her, hers
- He, him, his
- They, them, theirs
- Ze, hir, hirs
- Just my name, please
Applicant Documents
Required Documents
Optional Documents
- Resume
- Cover Letter
Open Date
02/14/2023
Requisition Number
PRN33876B
Job Title
PS Clinical Research Coord
Working Title
PS 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
M-F 9-5
VP Area
President
Department
01619 - HCI CORNELIA ULRICH RES PROG
Location
Campus
City
Salt Lake City, UT
Type of Recruitment
External Posting
Pay Rate Range
53500 to 58000
Close Date
Open Until Filled
Yes
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