Manager Clinical Research - Herma Heart Institute - Pediatrics jobs in United States
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Medical College of Wisconsin · 12 hours ago

Manager Clinical Research - Herma Heart Institute - Pediatrics

The Medical College of Wisconsin is a healthcare institution seeking a Manager for Clinical Research at the Herma Heart Institute. The role involves managing clinical trial initiatives, ensuring compliance with regulations, and overseeing a team of clinical research coordinators while collaborating with various departments to advance research goals.

EducationHigher EducationMedical
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H1B Sponsor Likelynote

Responsibilities

Act as a resource for investigators and support staff on clinical pre-trial functions including budget development, contract negotiations, IRB applications, FDA regulations, and grant development. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research
Develop and implement department policies, procedures and organizational tools to ensure compliance with MCW, state and federal standards. May act as a liaison between primary investigator (PI) and sponsors on regulatory quality control and quality assurance matters
Manage data systems supporting research activities. Correspond with IRBs as needed
Partner with business manager in the development and management of clinical research budgets. Maintain understanding of the research project budgetary requirements
Manage Clinical Research Coordinator team within Herma Heart Institute. Recruit and train clinical research staff, nurses, and clinical research coordinators; develop and implement standardized expectations for all subordinates; assess, monitor and evaluate work load and performance. Mentor and direct staff to achieve research goals
Act as a liaison between internal and external clinical research operations teams. Work closely with other departments and external agencies to advance the Herma Heart Institute research goals and initiatives
Develop, implement and monitor clinical research activities. Implement and conduct quality control processes to ensure the highest data and research standards
Develop clinical review data review plan and check specifications. Utilize quality improvement tools and statistical process control to facilitate improvement of systems and processes
Perform as a study coordinator for select projects
Document clinical research activities. Generate monthly updates on activities and annual reports on research accomplishments
Facilitate timely review and processing of research study proposals. Assemble ad hoc committees as needed
Support investigator and staff access to research core resources via the Children’s Research Institute and the CTSI of Southeastern Wisconsin
Partner during the transition of basic science or translational research into clinical practice
Remain informed about developments and innovations in the field of pediatric Cardiothoracic Surgery and Cardiology research, research tools, and techniques
Perform other duties as assigned

Qualification

Clinical research managementRegulatory complianceBudget developmentClinical research coordinatorData managementQuality control processesCITI trainingResource managementBiology knowledgeChemistry knowledgeMathematics knowledgeDocumentation managementCritical thinkingProblem solvingWriting skills

Required

Bachelor's degree
6 years of clinical research experience
CCRC or CCRP required
CITI training required within 90 days of hire

Preferred

Master's preferred in a scientific field or healthcare management
6 years of direct clinical research coordinator and operations experience

Benefits

Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
403B Retirement Package
Competitive Vacation and Paid Holidays offered
Tuition Reimbursement
Paid Parental Leave
Employee & Family Assistance Program (EFAP)
Pet Insurance
On campus Fitness Facility, offering onsite classes
Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

Company

Medical College of Wisconsin

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Medical College of Wisconsin is a school in Milwaukee.

H1B Sponsorship

Medical College of Wisconsin has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (139)
2024 (70)
2023 (70)
2022 (81)
2021 (67)
2020 (65)

Funding

Current Stage
Late Stage
Total Funding
$22.7M
Key Investors
US Department of Commerce, Economic Development AdministationNational Institutes of HealthPaula and Rodger Riney Foundation
2024-07-03Grant
2023-08-17Grant
2022-08-25Grant· $5.9M

Leadership Team

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John R. Raymond
President and CEO
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Company data provided by crunchbase