Clinical Research Project Manager
University of Kentucky
Lexington, KY
Full-time
Research
Posted on April 19, 2024
Posting Details
Posting Details
Job Title
Clinical Research Project Manager
Requisition Number
RE44968
Working Title
QA DSMC Manager
Department Name
7H025:CANCER CENTER-CORE SUPPORT
Work Location
Lexington, KY
Grade Level
46
Salary Range
$51,491-84,950/year
Type of Position
Staff
Position Time Status
Full-Time
Required Education
MA
Click here for more information about equivalencies:
https://hr.uky.edu/employment/working-uk/equivalencies
Required Related Experience
3 yrs
Required License/Registration/Certification
Certified Clinical Research Professional ( CCRP), Certified Clinical Research Associate ( CCRA) or other nationally required certification
Physical Requirements
Requires handling of light-weight objects up to 10 pounds, sitting for long periods of time, some standing or walking, repetitive motion.
Shift
Monday-Friday 8:00am-5:00pm (40 hours/wk)
Job Summary
The Markey Cancer Center is recruiting for a Clinical Research Project Manager to work in our Quality Assurance Office to provide management to ensure efficient operations as well as facilitate the provision of collaborative research functions.
Direct duties will include the program management of the Markey Cancer Center Data and Safety Monitoring Committee; manage compliance and safety reports; work collaboratively with the QAPI Program Manager to coordinate and participate research activities of the Quality Assurance Office. Act as a liaison with CRO, PMC and MCCRN investigators, sponsor representatives and clinical research teams; provide training and education to faculty and staff for protocol review and data and safety monitoring. Utilize knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI and CTMB. Perform other duties as assigned.
This position is eligible for a remote work arrangement with supervisor approval.
IMPORTANT: Resumes and CVs cannot be substituted for a completed application. Incomplete applications could disqualify you from being considered for this position. If the information on your resume is not entered on the application, this will prevent us from being able to assess your education and experience when trying to determine a salary offer. To be considered you must fully complete the online application being sure to only put one (1) job title for each entry (multiple job titles for one employer must have separate entries), the # of hours worked per week and your ending salary. You will also be required to upload a cover letter, resume, and as Specific Request #1, attach a copy of your certification (e.g., SoCRA-CCRP; ACRP-CCRC or CCRA; HCCA/CHRC; SQA-RQAP, CIP, PMP, CAPM or other certification specifically related to research, quality, or compliance).
To view our exceptional benefits, please visit https://www.uky.edu/hr/benefits.
Skills / Knowledge / Abilities
Microsoft Office Suite, Excel, Adobe, One Note, Teams, research databases, HIPAA, HSP, knowledge of Federal guidance documents; CFR, GCP; NCI & CTMB guidelines & OHRP, knowledge of oncology trials.
Does this position have supervisory responsibilities?
No
Preferred Education/Experience
Bachelors degree with more than 7 years experience. Work experience in program coordination and clinical research; Work experience in oncology clinical research and federal regulations/ HSP.
Deadline to Apply
04/25/2024
University Community of Inclusion
The University of Kentucky is committed to a diverse and inclusive workforce by ensuring all our students, faculty, and staff work in an environment of openness and acceptance. We strive to foster a community where people of all backgrounds, identities, and perspectives can feel secure and welcome. We also value the well-being of each of our employees and are dedicated to creating a healthy place to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors the University of Kentucky is a Tobacco & Drug Free campus.
As an Equal Opportunity Employer, we strongly encourage veterans, individuals with disabilities, women, and all minorities to consider our employment opportunities.
Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
Required Documents
Posting Details
Job Title
Clinical Research Project Manager
Requisition Number
RE44968
Working Title
QA DSMC Manager
Department Name
7H025:CANCER CENTER-CORE SUPPORT
Work Location
Lexington, KY
Grade Level
46
Salary Range
$51,491-84,950/year
Type of Position
Staff
Position Time Status
Full-Time
Required Education
MA
Click here for more information about equivalencies:
https://hr.uky.edu/employment/working-uk/equivalencies
Required Related Experience
3 yrs
Required License/Registration/Certification
Certified Clinical Research Professional ( CCRP), Certified Clinical Research Associate ( CCRA) or other nationally required certification
Physical Requirements
Requires handling of light-weight objects up to 10 pounds, sitting for long periods of time, some standing or walking, repetitive motion.
Shift
Monday-Friday 8:00am-5:00pm (40 hours/wk)
Job Summary
The Markey Cancer Center is recruiting for a Clinical Research Project Manager to work in our Quality Assurance Office to provide management to ensure efficient operations as well as facilitate the provision of collaborative research functions.
Direct duties will include the program management of the Markey Cancer Center Data and Safety Monitoring Committee; manage compliance and safety reports; work collaboratively with the QAPI Program Manager to coordinate and participate research activities of the Quality Assurance Office. Act as a liaison with CRO, PMC and MCCRN investigators, sponsor representatives and clinical research teams; provide training and education to faculty and staff for protocol review and data and safety monitoring. Utilize knowledge of FDA Guidance Documents, CFR, GCP, NIH, NCI, ORI and CTMB. Perform other duties as assigned.
This position is eligible for a remote work arrangement with supervisor approval.
IMPORTANT: Resumes and CVs cannot be substituted for a completed application. Incomplete applications could disqualify you from being considered for this position. If the information on your resume is not entered on the application, this will prevent us from being able to assess your education and experience when trying to determine a salary offer. To be considered you must fully complete the online application being sure to only put one (1) job title for each entry (multiple job titles for one employer must have separate entries), the # of hours worked per week and your ending salary. You will also be required to upload a cover letter, resume, and as Specific Request #1, attach a copy of your certification (e.g., SoCRA-CCRP; ACRP-CCRC or CCRA; HCCA/CHRC; SQA-RQAP, CIP, PMP, CAPM or other certification specifically related to research, quality, or compliance).
To view our exceptional benefits, please visit https://www.uky.edu/hr/benefits.
Skills / Knowledge / Abilities
Microsoft Office Suite, Excel, Adobe, One Note, Teams, research databases, HIPAA, HSP, knowledge of Federal guidance documents; CFR, GCP; NCI & CTMB guidelines & OHRP, knowledge of oncology trials.
Does this position have supervisory responsibilities?
No
Preferred Education/Experience
Bachelors degree with more than 7 years experience. Work experience in program coordination and clinical research; Work experience in oncology clinical research and federal regulations/ HSP.
Deadline to Apply
04/25/2024
University Community of Inclusion
The University of Kentucky is committed to a diverse and inclusive workforce by ensuring all our students, faculty, and staff work in an environment of openness and acceptance. We strive to foster a community where people of all backgrounds, identities, and perspectives can feel secure and welcome. We also value the well-being of each of our employees and are dedicated to creating a healthy place to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors the University of Kentucky is a Tobacco & Drug Free campus.
As an Equal Opportunity Employer, we strongly encourage veterans, individuals with disabilities, women, and all minorities to consider our employment opportunities.
Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.
Posting Specific Questions
Required fields are indicated with an asterisk (*).
- * Describe your greatest challenge in clinical research and your specific efforts to generate results in regards to this challenge.
(Open Ended Question) - * Please identify the professional certification that you currently hold in clinical research, compliance, or project coordination.
- SoCRA - CCRP
- ACRP - CCRC or CCRA
- HCCA - CHRC
- SQA – RQAP, CIP
- PMP - CAPM or PMP
- None of the above
- * Which of the following best describes your highest level of experience using study or data management computer systems:
- Have worked with in-house developed study and data systems in the capacity of data entry and data management (i.e., Excel, Access).
- Have worked with one or more commercial study management or data systems in the capacity of data entry.
- Have worked with one or more commercial study management or data systems in the capacity of data entry and generating reports.
- Have worked with multiple study management and data systems to perform data management and/or data entry.
- * Please describe your previous work experience in project management.
(Open Ended Question) - * Please describe your previous work experience in clinical research.
(Open Ended Question) - * University of Kentucky HealthCare seeks to attract, develop and retain highly skilled and competent employees, to provide the best experience for every patient, every time. If selected for a position, do you agree to abide by the UK HealthCare Values of diversity, innovation, respect, compassion, and teamwork?
- Yes
- No
- * University of Kentucky HealthCare recognizes a set of values that guide us in our daily interactions. By applying for a position within UK Healthcare, you are indicating your commitment and expressing your agreement to our five values. These values are diversity, innovation, respect, compassion, and teamwork. Please choose one of the UK Healthcare values and give a specific example when you exhibited this quality in your professional experience.
(Open Ended Question) - * Where did you first see this position advertised other than on UK's online employment system?
- InsideHigherEd.com
- HigherEdJobs.com
- Diverseeducation.com (Diverse Issues in Higher Education)
- Latinosinhighered.com
- HospitalCareers.com
- Indeed.com
- LinkedIn.com
- Higher Education Recruitment Consortium (hercjobs.org)
- A Colleague, Friend and/or Family Member
- Careerbuilder.com
- UK Job Fair
- None of the Above
Required Documents
- Resume
- Cover Letter
- Specific Request 1
