PS Study Coordinator
University of Utah
Salt Lake City, UT
Full-time
Manufacturing / Production / Operations
Posted on June 6, 2023
Announcement
Details
Open Date
03/10/2022
Requisition Number
PRN29693B
Job Title
PS Study Coordinator
Working Title
PS Study Coordinator
Job Grade
D
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
U of U Health - Academics
Department
00246 - Human Genetics
Location
Campus
City
Salt Lake City, UT
Type of Recruitment
External Posting
Pay Rate Range
31600 to 58400
Close Date
Open Until Filled
Yes
Job Summary
The Utah Genome Project within the Department of Human Genetics of the University of Utah School of Medicine has an immediate need for a Study Coordinator. This position coordinates technical and administrative details involved in a clinical or research study. Assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures. Position will perform study conduct with coordinator team related to Human Genetic research in healthy individuals and rare diseases. This study coordinator would be responsible for coordinating and scheduling group study visits in the research clinic and the community.
The overall objective of the Utah Genome Project is to create and manage a large data and sample biorepository for investigators' future research projects aiming to identify genetic factors that influence human health including susceptibility and resistance to disease traits, response to external influences (medication, diet and environment), and aspects of healthy individuals. The Utah Genome Project is actively enrolling new subjects for prospective data and sample collection, as well as, interacting with previous genetic research subjects and managing their data.
Responsibilities
Scheduling and organizing study visits .
Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines. Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety. Determines length of visits and coordinates related facility and equipment availability. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor. Completes, audits, corrects CRFs, relays CRFs to sponsor. Assists with negotiating contract budget and payment terms. Maintains documents as required by FDA guidelines.
May maintain contact with IRB and prepare and submit IRB documents. May ensure proper collection, processing and shipment of specimens. May perform functions required of the Clinical Research Assistant as necessary.
Work Environment and Level of Frequency that may be 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 a related field, or equivalency required. IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire and demonstrated human relations and effective communication skills are also required.
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.
Some departments may require IATA DGR training within six months.
Preferences
Strongly Preferred:
Phlebotomy skills or willingness to undergo phlebotomy certification through job.
Evidence of ability to recruit and communicate over the phone.
Preferred:
Knowledge of Good Clinical Practices and HIPAA; understanding of research procedures; attention to detail; organizational skills; and the ability to work with a team effectively. Excellent interpersonal and communications skills, both oral and written. Proficiency in Microsoft Office and ability to learn new software programs.
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)
135 Park Building
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.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
Required Documents
Details
Open Date
03/10/2022
Requisition Number
PRN29693B
Job Title
PS Study Coordinator
Working Title
PS Study Coordinator
Job Grade
D
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
U of U Health - Academics
Department
00246 - Human Genetics
Location
Campus
City
Salt Lake City, UT
Type of Recruitment
External Posting
Pay Rate Range
31600 to 58400
Close Date
Open Until Filled
Yes
Job Summary
The Utah Genome Project within the Department of Human Genetics of the University of Utah School of Medicine has an immediate need for a Study Coordinator. This position coordinates technical and administrative details involved in a clinical or research study. Assists the Principal Investigator in achieving study integrity and objectives through the successful implementation and completion of protocols and procedures. Position will perform study conduct with coordinator team related to Human Genetic research in healthy individuals and rare diseases. This study coordinator would be responsible for coordinating and scheduling group study visits in the research clinic and the community.
The overall objective of the Utah Genome Project is to create and manage a large data and sample biorepository for investigators' future research projects aiming to identify genetic factors that influence human health including susceptibility and resistance to disease traits, response to external influences (medication, diet and environment), and aspects of healthy individuals. The Utah Genome Project is actively enrolling new subjects for prospective data and sample collection, as well as, interacting with previous genetic research subjects and managing their data.
Responsibilities
Scheduling and organizing study visits .
Assesses protocol for clarity and subject safety, reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines. Explains and obtains informed consent, medical history and demographics; documents in source file and maintains with historical data, status reports, progress notes, and subject log to help ensure subject safety. Determines length of visits and coordinates related facility and equipment availability. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor. Documents all protocol deviations, reconciles test article accountability at study close out and prepares summary report for sponsor. Completes, audits, corrects CRFs, relays CRFs to sponsor. Assists with negotiating contract budget and payment terms. Maintains documents as required by FDA guidelines.
May maintain contact with IRB and prepare and submit IRB documents. May ensure proper collection, processing and shipment of specimens. May perform functions required of the Clinical Research Assistant as necessary.
Work Environment and Level of Frequency that may be 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 a related field, or equivalency required. IRB CITI Course in the Protection of Human Research subjects certificate obtained within six months of hire and demonstrated human relations and effective communication skills are also required.
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.
Some departments may require IATA DGR training within six months.
Preferences
Strongly Preferred:
Phlebotomy skills or willingness to undergo phlebotomy certification through job.
Evidence of ability to recruit and communicate over the phone.
Preferred:
Knowledge of Good Clinical Practices and HIPAA; understanding of research procedures; attention to detail; organizational skills; and the ability to work with a team effectively. Excellent interpersonal and communications skills, both oral and written. Proficiency in Microsoft Office and ability to learn new software programs.
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)
135 Park Building
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.
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
Required Documents
- Resume
- Cover Letter
- Addendum to the University of Utah - Veteran Only - Call 801.581.2169 after submission
- Appropriate discharge document (such as a DD-214 – Member Copy 4) – Veteran Only – Call 801.581.2169
- List of References