The Surgical Clinical Research Manager is responsible for leading the clinical research program and the Office of Clinical Research (OCR) in the UW Madison Department of Surgery (DOS) and reports directly to the Director of Surgical Research Operations. The OCR provides full-service study coordination and regulatory services for industry, extramurally and government funded, as well as investigator-initiated interventional studies including drug and device trials. This position will work closely with department leadership including the Director of Surgical Research Operations and Research Vice-Chairs and with key personnel outside of the department including individuals in the Office of Clinical Research within UW Health and the School of Medicine and Public Health.
The Surgical Clinical Research Manager will provide clinical research leadership to: - Develop goals for growth, innovation, process improvement, and sustainability for the OCR and the clinical research program - Ensure compliant and high quality research - Facilitate relationships with clinical providers in multiple care areas (ICU, emergency department, operating room, etc.), industry sponsors, faculty, residents, staff, and research trainees - Participate in strategic initiatives under the direction of the Chief Clinical Research Officer/Director of Clinical Trials Development and Accreditation at UW Health and SMPH.
This position will provide day to day oversight and support to the OCR including: - Managing the portfolio of studies, establishing policies and procedures, and managing the OCR budget and finances - Supervising a clinical research supervisor, regulatory staff, a protocol activation coordinator, and other support staff within the OCR o The regulatory team provides services such as IRB submissions, FDA submissions, and internal and external audit and inspection management. o The clinical research coordinator team provides 24/7 on-call coverage through a balanced on-call model. The Surgical Clinical Research Manager may need to be available to be periodically contacted outside normal hours to support on-call staff and activities. - Provides direction and issue resolution for study-related concerns and risks.
SMPH is committed to being a diverse, equitable, inclusive and anti-racist workplace and is an Equal Employment Opportunity, Affirmative Action employer. Applications from Black, Indigenous and People of Color (BIPOC) individuals, LGBTQ+ and non-binary identities, women, persons with disabilities, military service members and veterans are strongly encouraged.
Plans, develops, and directs a clinical research program within a division, center, or department. Solicits clinical research opportunities, develops policies and procedures, and has significant responsibility for the overall functioning and effectiveness of the clinical research. Supervises clinical research staff.
20% Plans staff implementation of protocols and on-going quality review of one or multiple, basic or moderately complex clinical research trials or programs
20% Analyzes research portfolios and accounts, solicits internal and external research opportunities, promotes unit capabilities, and makes recommendations to leadership for strategic program enhancements
10% Compiles audits and documents research data to ensure necessary compliance with institutional policies and procedures
5% Composes, assembles, and submits grant proposals and protocols according to applicable rules and regulations
20% Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 full-time equivalent (FTE) employees
5% Develops and monitors the program budget; and reviews and approves expenditures
10% Collaborates with UW Health and SMPH Leadership to support department and institutional clinical trial strategic goals
5% Interfaces with clinical providers to support 24/7 activities across phases of care
5% Provides mentorship and guidance to faculty on their clinical research, including but not limited to, feasibility assessments and consultation on new projects and opportunities
Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.
The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.
Required Bachelor's Degree in business administration, biological sciences, or health-related field is required.
Required Qualifications - Bachelor's degree in business administration, biological sciences, or health-related field is required. - At least five years of recent, progressively responsible experience coordinating clinical research involving pharmaceutical, device, and/or biological products is required. - At least two years of supervisory experience with a clinical research team is required.
Preferred Qualifications - Clinical Research Professional or Certified Clinical Research Coordinator certification - Experience in coordinating drug and/or device trials - Experience with regulatory services including IRB submissions and FDA submissions - Experience conducting clinical research in an academic medical center
An ideal candidate will be: - Very knowledgeable about current clinical research regulations and good clinical practices - A proven team leader with exemplary skills in process/change management - A highly skilled mentor and communicator able to engage professionally with a wide variety of individuals - A problem solver, highly collaborative, adaptive, proactive, and committed to creating a positive work environment that is transparent, cooperative, and trusting.
This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.
Appointment Type, Duration:
Minimum $80,000 ANNUAL (12 months) Depending on Qualifications The starting salary for the position is $80,000 but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/)
This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.
The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position.
The department will not be able to support a request for a J-1 waiver. If you chose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees.
How to Apply:
To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications relevant to the position. You will also be asked to provide contact information for three (3) references, including your current/most recent supervisor during the application process. References will not be contacted without prior notice.
Samantha Connell email@example.com 608-265-5311 Relay Access (WTRS): 7-1-1 (out-of-state: TTY: 800.947.3529, STS: 800.833.7637) and above Phone number (See RELAY_SERVICE for further information. )
Clinical Research Manager(RE018)
A539710-MEDICAL SCHOOL/SURGERY/RESEARCH ADMIN
The University of Wisconsin is an Equal Opportunity and Affirmative Action Employer. We promote excellence through diversity and encourage all qualified individuals to apply.
Employment will require a criminal background check. It will also require you and your references to answer questions regarding sexual violence and sexual harassment.
The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).
The University of Wisconsin–Madison has been a catalyst for the extraordinary since its founding in 1848. Our students, staff, and faculty partake in world-class education and conduct prolific research that solves real-world problems. Our guiding principle is the Wisconsin Idea, a commitment to outreach that creates a better future for our state, our nation, and the world. We value the contributions of each person and recognize that diversity is a source of strength, creativity, and innovation.