Job Class: 8352P4 - Research Professional 4
Working Title: Clinical Research Project Lead
Supervisor: Mary Farnsworth

Program Description:
At the University of Minnesota, Department of Surgery, our experts, care teams and researchers are advancing science and patient care.

The Surgery Clinical Trials Office (SurgCTO) supports a variety of research projects and portfolios in the Department of Surgery. We serve the University's research mission by providing comprehensive research support to faculty investigators conducting medical research. We accomplish our mission by 1) developing competent professionals specialized in clinical research, 2) creating effective and efficient pathways for conducting compliant clinical research, and 3) fostering a participant-centric research culture.

We especially strive to have our community better reflect the broad range of identities in our state, including race, ethnicity, gender identity, gender expression, sexual orientation, language, disability, age, national origin, religious practice, access to health services, and socioeconomic status. Our program seeks to foster an inclusive environment in which members from diverse backgrounds are encouraged to develop their skills of scientific inquiry.

Position Summary:
In close partnership with the SurgCTO leadership team (Clinical Research Operations Director and Program Managers), this position is responsible for the research operations of a portfolio of research studies within assigned Surgical divisions. The Clinical Research Project Lead serves as a technical expert for all aspects of research implementation and serves as an on-the-ground resource for investigators. The Clinical Research Project Lead is integral to ensuring optimal utilization of SurgCTO, University of Minnesota, Fairview, and MHealth resources. Research Project Lead duties include: assisting with the development of research studies, securing regulatory approvals, partnering with unit leadership on budget development and financial management, monitoring study accrual, and ensuring successful overall study coordination and compliance with applicable regulations and guidelines. The Clinical Research Project Lead works independently to solve issues of moderate complexity, but receives guidance and direct support/training in complex situations. Occasional evenings, weekends, and on-call duties may be required. There may be times that the nature of this work would require that the employee be considered an 'essential employee.'


Major Duties/Job Description:

Clinical Trial Portfolio Management and Oversight (50%)
* Support faculty: serve as a resource to faculty and staff conducting research, both ad-hoc generically and throughout the lifecycle of any given research project.
* Serve as the point-person and provide guidance for investigators on resourcing needs required to advance clinical research and assist investigators with gaining access to respective resources. This includes the identification and coordination of internal and external stakeholders (e.g. biostatistics, recruitment, information, regulatory, finance, data management, study coordination, outside industry sponsors, cooperative croups, University consortiums, etc.).
* Efficiently and effectively participate in study start-up, which includes:
o Determining billing designations, informing calendar build, ensuring accurate pricing and budget development; assist the OM, as requested, with budget development and negotiation for industry-sponsored trials; partner with Surgery Grants and Contracts (SGC) for grants and subawards
o Ensuring IRB and other regulatory approvals
o Collaborate with clinical partners to establish study logistics, including specimen collection and management, investigational product management, clinical procedures, etc.
o Serve as point person for faculty investigators and research sponsors; build effective relationships that uphold ethical standards and promote high quality research
o Facilitating effective project planning and start-up for investigator-initiated research following federal regulations and local policies
* Ensure compliance with University requirements for registering research projects, obtaining ancillary reviews, and updating study records in the Clinical Trial Management System.
* Utilize extensive knowledge and comprehension of Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, and National Institute of Health (NIH) research rules to oversee all aspects of study conduct. Apply them to the design, conduct, performance, monitoring, recording, analysis, and reporting of clinical trials to protect the health and safety of human subjects and to meet all regulatory requirements.
* Lead routine meetings with research staff, Principal Investigators, assigned Surgical Divisions and other relevant stakeholders.
* In partnership with the Clinical Trial Support Specialist (CTSS) and Department staff, participate in the development of data collection instruments and procedures for assigned projects. Participate in the development and management or projects throughout the study lifecycle.

Regulatory and Clinical Research Coordination (20%)
* Responsible for initiating all regulatory tasks associated with assigned portfolio, including, but not limited to: initial IRB application, any ceding tasks, regulatory document creation and collection, and ongoing reporting requirements.
* May delegate and work with the assistance of the Clinical Trial Support Specialist to collect necessary regulatory documents and to establish any e-binders.
* Facilitate the timely review and reporting of adverse reactions and severe adverse events
* Be primary contact and information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimen needs, and other research-related resources.
* Engage with investigators and ensure research procedures comply with regulations, policies, and best practices.

Research Operations, Compliance and Process Improvement (10%)
* Serve as a Quality Management resource.
* Review monitoring reports and data quality reports to identify trends and resolve problems. This includes development of action plans utilizing SurgCTO processes and available resources.
* Lead audits, implement Corrective and Preventative Action (CAPA) plans. Serve as a liaison between the sponsors, investigator, and any governing body on audit findings.
* Oversee completeness of Clinical Trial Management System, Clinicaltrials.gov, and unit specific tracking tools for assigned projects.
* Support development of standardized research practices and workflows.
* Attend professional development and training sessions to ensure compliance with newest policies and procedures.
* Monitor trends and offer suggestions for improvements to unit leadership.
* Assist with quality monitoring according to departmental procedures.
* Support other special projects and program initiatives as directed.

Staff Development and Mentorship (15%)
* Provide indirect oversight and mentoring of research support staff assigned within the assigned portfolio.
* Evaluate staff workload and collaborate with Department Supervisors on the identification of training or development needs and communicate anticipated future project staffing needs.
* Provide ongoing education and training to faculty and staff on regulatory processes.
* Contribute, upon request, to interview and hiring process of entry-level staff (coordinators, data coordinators, or trial assistants), and training new team members.

Publications Facilitation (5%)
* Prepare and submit manuscripts, articles, abstracts, research reports, and presentations.
* Collaborate with department administrators, grants management team, and division chairs to increase DOS visibility in the scientific community.
* Source publication opportunities and manage deadlines.
* Contribute to the production of research publications or presentations of research data.

All required qualifications must be documented on application materials

Required Qualifications
* BA/BS in a related field, and five years of relevant experience; or advanced degree with three years of relevant experience; or a combination of related education and experience to total nine years
* Expert knowledge of the federal regulations governing human subject research, including protections for vulnerable populations
* Experience preparing and managing IRB and other regulatory review submissions, including securing initial IRB approvals and required pre-review approvals.
* Computer proficiency, and ability to navigate multiple software applications
* Electronic document management experience and strong skills with Adobe and Microsoft Word
* Detail-oriented with exceptional organizational, planning and problem-solving skills
* Ability to work independently, as part of a team, with changing priorities
* Demonstrated ability to meet deadlines and prioritize assignments
* Excellent written, verbal and interpersonal skills

Preferred Qualifications
* Masters-level degree in relevant field
* Experience in an academic setting
* Project management experience
* Clinical Research Certification (CCRC or CCRP)
* Research or clinical experience in one of the following clinical fields: Critical Care, Interventional Radiology, Pediatric Cardiac Surgery, Pediatric Surgery, or Vascular Surgery

To learn more about the Department oTo learn more about the Department of Surgery, please visit:

Working at the University

At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.

The University also offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the
• 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)
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• with free or reduced rates in the Twin Cities metro area

Please visit the for more information regarding benefits.

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

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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 is committed to attracting and retaining employees with varying identities and backgrounds.

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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.

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