Clinical Research Lead
2 days ago
We are seeking a highly skilled Clinical Research Lead to join our team at the University of Minnesota. As a key member of our research team, you will be responsible for overseeing the development and implementation of clinical trials, ensuring compliance with regulatory requirements, and collaborating with investigators, project managers, and other study staff.
Responsibilities:- Develop and write Investigational Device Exemption (IDE) and Institutional Review Board (IRB) protocols for clinical trials of neurostimulation therapies.
- Supervise and train coordinators and regulatory staff in ensuring all regulatory requirements are met and documented for clinical trials.
- Maintain awareness of and update study practices to reflect ongoing developments in regulatory guidance related to neurotechnologies.
- Develop, maintain, and track study budgets and associated documents, including budgets associated with grant submissions.
- Maintain liaison and strong working relationships with study financial sponsors, device manufacturers, representatives of regulatory bodies, data analytic staff, and University administrators.
- Coordinate high-level or mission-critical aspects of clinical studies, such as study device implantation, storage and proper handling of investigational product, data safety and monitoring board liaison, and harmonization of research procedures across studies.
- Evaluate, hire, onboard, and generally supervise study staff across the clinical portfolio.
- Manage study and portfolio staffing by forecasting staffing needs, hiring and training staff, and managing workloads and project timelines.
- Serve as a representative on various teams and committees making decisions and recommendations on behalf of the laboratory.
- Requires BA/BS with at least 8 years of experience or advanced degree with 6 years of experience and prior oversight of a small department or cross-disciplinary team.
- Clinical degree permitting performance of low-risk study procedures under physician supervision.
- At least 2 years of prior experience in a research setting.
- In good ethical and professional standing sufficient to participate as an investigator on Federally funded research studies.
The Department of Psychiatry & Behavioral Sciences consists of an outstanding team of researchers, clinicians, and educators who provide world-class expertise in psychiatric illness, treatment, scholarship, and scientific discovery.
Our mission is to:
- Create and disseminate new knowledge in the science of mental health.
- Provide effective and innovative clinical care programs to alleviate the suffering of mental illness and promote mental resilience.
- Train the next generation of interprofessional experts who will be leaders in Minnesota and beyond.
- Engage in compassionate and vigorous outreach and advocacy on issues relevant to psychiatric illness, treatment, and research.
You can find more information on our website at https://www.psychiatry.umn.edu/.
Benefits:Working at the University of Minnesota offers a comprehensive benefits package, including competitive wages, paid holidays, and generous time off, continuous learning opportunities, low-cost medical, dental, and pharmacy plans, healthcare and dependent care flexible spending accounts, University HSA contributions, disability and employer-paid life insurance, employee wellbeing program, excellent retirement plans with employer contribution, Public Service Loan Forgiveness (PSLF) opportunity, financial counseling services, and Employee Assistance Program with eight sessions of counseling at no cost.
Please visit the Office of Human Resources website for more information regarding benefits.
How to Apply:Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will have the opportunity to complete an online application for the position and attach a cover letter and resume.
Additional documents may be attached after application by accessing your My Job Applications page and uploading documents in the My Cover Letters and Attachments section.
Questions about responsibilities, scope of work, or other aspects of this position are welcomed by the laboratory PI, Dr. Alik Widge, and can be directed to https://www.psychiatry.umn.edu/.
This position will remain open until filled.
To request an accommodation during the application process, please e-mail https://www.psychiatry.umn.edu/ or call https://www.psychiatry.umn.edu/.
Diversity:The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission.
The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression.
To learn more about diversity at the U: https://diversity.umn.edu/.
Employment Requirements:Any offer of employment is contingent upon the successful completion of a background check.
Our presumption is that prospective employees are eligible to work here.
Criminal convictions do not automatically disqualify finalists from employment.
About the U of M:The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research.
Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2020).
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