University of Minnesota
Clinical Research Manager- Department of Urology
University of Minnesota, Saint Paul, Minnesota, United States, 55199
About the Job
The Department of Urology is seeking a Clinical Research Manager (Research Professional 4- Clinical Research) to manage its research portfolio. The position will work in partnership with Department leadership to develop and implement strategy aimed at continued research growth. The Clinical Research Manager will provide strategic leadership and oversight of day-to-day operations related to the conduct of all clinical research for the Department of Urology research portfolio. The Manager will partner with PIs, administration, and other faculty and staff to ensure research requirements are met and departmental research needs are addressed. This individual will lead PIs and staff through all aspects of study conduct, including grant submissions, start-up procedures (regulatory, budget, etc.), implementation, ongoing conduct and trial management, and close-out.
Job Responsibilities
The Department of UrologyClinical Research Manager will manage the research portfolio and provide strategic leadership.
Study Participant Recruitment and Management - 40%
Evaluate and assign participant recruitment efforts to clinical trial coordinators.
Lead consenting and enroll appropriate participants with regard to the established protocols.
Manage coordination of participant study visits with the clinical trial team.
Schedule clinic appointments, procedures, testing, labs, and imaging per study protocol requirements.
Manage appropriate billing designation for the study visits by clinical trial coordinators.
Manage study data and collect appropriate data directly (adverse events, protocol deviations, questionnaires, etc.).
Enter data into eCRF platforms and address queries as needed.
Coordinate and oversee monitor visits by sponsors and audits by HRPP.
Research Manager of Clinical Trial Team - 35%
Supervise research coordinators working on business and industry grants. Assign staff to PIs for daily work instruction on projects.
Recommend hiring of new staff and ensure proper orientation and training.
Write and update job descriptions; delegate duties; conduct performance appraisals; monitor progress on goals.
Ensure professional development of staff to ensure good clinical practice.
Study Start-up - 25%
Participate in site qualification visits and protocol training sessions with industry sponsors.
Prepare and complete IRB applications in coordination with sponsoring companies and investigators.
Facilitate appropriate ancillary review processes.
Serve as a liaison between investigators, sponsors, and regulatory committees.
Ensure compliance throughout the duration of the study.
Regulatory document maintenance.
Negotiate budgets with sponsoring companies.
Create protocol calendars in OnCore.
Qualifications All required qualifications must be listed on resume.
Required Qualifications:
Bachelor’s degree in a life science, healthcare, or related field, plus at least five years of hands-on experience in clinical trial management from study startup through closure OR a combination of education and relevant work experience to equal at least nine years
Knowledge of research methodology.
A thorough understanding of global regulatory requirements and guidelines, such as ICH-GCP.
Excellent written and verbal communication skills for collaborating with multidisciplinary teams and stakeholders.
Preferred Qualifications:
Master’s degree or Certified Clinical Research Professional (CCRP).
Experience in supervising and mentoring clinical research teams.
Demonstrated ability to work independently and as part of a team.
About the Department To learn more about the Department of Urology, please visit: med.umn.edu/urology.
Pay and Benefits Pay Range:
$35.34- $38.46 per hour ($73,500- $80,000 annually), depending on education/qualifications/experience
Time Appointment Category:
75%-100% Appointment (If not specified, assume 100%.)
Position Type:
Civil-Service & Non-Faculty Labor Represented Staff
Additional information regarding benefits is available through the University of Minnesota Office of Human Resources. The University offers a comprehensive benefits package, including: wages, holidays, time off, tuition benefits, health plans, flexible spending accounts, retirement plans, PSLF opportunity, and more.
How To Apply Applications must be submitted online. To be considered, click the Apply button and attach a cover letter and resume. You may add supporting documents after submission via the My Job Applications page. For accommodation requests during the application process, email employ@umn.edu or call (612) 624-8647.
Diversity The University of Minnesota is an equal opportunity employer and values diversity and inclusion in its employment practices. We prohibit discrimination based on race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. More at: diversity.umn.edu.
Employment Requirements Any offer of employment is contingent upon successful completion of a background check. The University presumes applicants are eligible to work. Criminal convictions do not automatically disqualify finalists.
About the U of M The University of Minnesota, Twin Cities (UMTC) is a large public research university offering a wide range of programs and opportunities. It is located in the Minneapolis–St. Paul metro area and partners with health centers, industry, government, and non-profit organizations. UMTC has been recognized as a Top Workplace and employer of choice by several rankings.
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Job Responsibilities
The Department of UrologyClinical Research Manager will manage the research portfolio and provide strategic leadership.
Study Participant Recruitment and Management - 40%
Evaluate and assign participant recruitment efforts to clinical trial coordinators.
Lead consenting and enroll appropriate participants with regard to the established protocols.
Manage coordination of participant study visits with the clinical trial team.
Schedule clinic appointments, procedures, testing, labs, and imaging per study protocol requirements.
Manage appropriate billing designation for the study visits by clinical trial coordinators.
Manage study data and collect appropriate data directly (adverse events, protocol deviations, questionnaires, etc.).
Enter data into eCRF platforms and address queries as needed.
Coordinate and oversee monitor visits by sponsors and audits by HRPP.
Research Manager of Clinical Trial Team - 35%
Supervise research coordinators working on business and industry grants. Assign staff to PIs for daily work instruction on projects.
Recommend hiring of new staff and ensure proper orientation and training.
Write and update job descriptions; delegate duties; conduct performance appraisals; monitor progress on goals.
Ensure professional development of staff to ensure good clinical practice.
Study Start-up - 25%
Participate in site qualification visits and protocol training sessions with industry sponsors.
Prepare and complete IRB applications in coordination with sponsoring companies and investigators.
Facilitate appropriate ancillary review processes.
Serve as a liaison between investigators, sponsors, and regulatory committees.
Ensure compliance throughout the duration of the study.
Regulatory document maintenance.
Negotiate budgets with sponsoring companies.
Create protocol calendars in OnCore.
Qualifications All required qualifications must be listed on resume.
Required Qualifications:
Bachelor’s degree in a life science, healthcare, or related field, plus at least five years of hands-on experience in clinical trial management from study startup through closure OR a combination of education and relevant work experience to equal at least nine years
Knowledge of research methodology.
A thorough understanding of global regulatory requirements and guidelines, such as ICH-GCP.
Excellent written and verbal communication skills for collaborating with multidisciplinary teams and stakeholders.
Preferred Qualifications:
Master’s degree or Certified Clinical Research Professional (CCRP).
Experience in supervising and mentoring clinical research teams.
Demonstrated ability to work independently and as part of a team.
About the Department To learn more about the Department of Urology, please visit: med.umn.edu/urology.
Pay and Benefits Pay Range:
$35.34- $38.46 per hour ($73,500- $80,000 annually), depending on education/qualifications/experience
Time Appointment Category:
75%-100% Appointment (If not specified, assume 100%.)
Position Type:
Civil-Service & Non-Faculty Labor Represented Staff
Additional information regarding benefits is available through the University of Minnesota Office of Human Resources. The University offers a comprehensive benefits package, including: wages, holidays, time off, tuition benefits, health plans, flexible spending accounts, retirement plans, PSLF opportunity, and more.
How To Apply Applications must be submitted online. To be considered, click the Apply button and attach a cover letter and resume. You may add supporting documents after submission via the My Job Applications page. For accommodation requests during the application process, email employ@umn.edu or call (612) 624-8647.
Diversity The University of Minnesota is an equal opportunity employer and values diversity and inclusion in its employment practices. We prohibit discrimination based on race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. More at: diversity.umn.edu.
Employment Requirements Any offer of employment is contingent upon successful completion of a background check. The University presumes applicants are eligible to work. Criminal convictions do not automatically disqualify finalists.
About the U of M The University of Minnesota, Twin Cities (UMTC) is a large public research university offering a wide range of programs and opportunities. It is located in the Minneapolis–St. Paul metro area and partners with health centers, industry, government, and non-profit organizations. UMTC has been recognized as a Top Workplace and employer of choice by several rankings.
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