Upper Midwest HERC

Clinical Trials Supervisor:
• %time
o 20% coordinator training
o 10% supervision
o 20% day to day guidance
o 40% study coordination
o 10% other

• Reporting structure
o Direct reports: Regulatory Specialist, Research Coordinator(s)
o Reports to: Research Manager

• Responsibilities
o Assist in the recruitment, onboarding and training of applicable new research staff hires
o Provide study-specific leadership, day-to-day supervision and training for directs to meet key benchmarks in the areas of study setup, participant recruitment and retention rates, development and implementation of data management systems, regulatory and reporting responsibilities
o Prioritize workload
o Assess staff performance, provide guidance, address learning needs, and evaluate outcomes
o Escalate recommendations, needs, or challenges to the Research Manager when appropriate

o Serve in primary or back up study coordinator role
 Identify and follow clinical trial subjects, accurately completing visit procedures and data collection according to the protocol while maintaining the health and safety of research subjects in accordance with applicable federal, state, and institutional regulations.
 Understand and interpret clinical research protocols, assess study needs, develop plans and tools for successful implementation, conduct and document visits, evaluate progress regularly, and provide input to integrate improvements.
 Obtain research consent/HIPAA and screen patients for eligibility based on medically complex inclusion and exclusion criteria, seeking investigator input as appropriate.
 Educate the patient as well as the legally authorized representative or family when applicable throughout the research participation process.
 Document research findings and data according to protocol requirements and timeline.
 Interact with study sponsors, CROs, monitors and other external partners to timely meet day to day needs of the study.
 

All required qualifications must be documented on application materials

Required Qualifications:
o BA/BS plus at least 4 years of experience or advanced degree plus 2 years of experience or a combination of related education and work experience to equal eight years; often the senior-most individual contributor in a department to whom other more junior employees go to for technical guidance.

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.

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