Job Class: 8354RP â“ Research Support Professional 4 -
Working Title: Clinical Research Project Specialist
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 project-level coordination and operational execution of a portfolio of research studies within assigned Surgical divisions. The Clinical Research Project Specialist serves as a subject matter resource on research implementation and serves as an on-the-ground resource for investigators. The Clinical Research Project Specialist supports the efficient use of resources within 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 Specialist works independently on project tasks of moderate complexity, but receives guidance
and direct support/training in complex situations. This is a project-focused role without supervisory or team leadership
responsibilities. 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 â˜essential employee.â™

This hybrid position will primarily work independently with day-to-day activities; and report to the unit Director of Operations. Given the supportive nature of the role, the successful candidate should expect to be in the office at minimum 3 days per week. The ability to work remotely exists and is dependent on work duties.

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 groups, University consortiums, etc.)
• Efficiently and effectively participate in study start-up, which includes:
  •  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
  •  Ensuring IRB and other regulatory approvals
  • Collaborate with clinical partners to establish study logistics, including specimen collection and management, investigational product management, clinical procedures, etc.
  • Serve as point person for faculty investigators and research sponsors; build effective relationships that uphold ethical standards and promote high quality research
  • 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 assigned Regulatory Specialist to collect necessary regulatory documents and to establish 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

Project-Based Staff Support and Knowledge Sharing (15%)

• Provide indirect oversight and mentoring of research support staff assigned within the assigned portfolio - providing project and disease specific training
• Collaborate with Operations Manager and department supervisors to assess project demands, identify team training or development needs, and share insight on future staffing requirements
• Support faculty and staff by providing ongoing education on regulatory requirements and processes relevant to research operations
•  Contribute, upon request, to interview and hiring process of entry-level staff (coordinators, data coordinators, or trial assistants) by offering input during interviews and assisting with onboarding and initial project-specific training
   

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

The employer reserves the right to change or assign other duties to this position.

All required qualifications must be included in the application material

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: Solid Organ Transplantation, Surgical Critical & Acute Care, Surgical Oncology

About University of Minnesota Twin Cities

The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.

Connections working at University of Minnesota Twin Cities