Clinical Research Manager - Cardiovascular and Cardiothoracic Research

Department: SOM KC Cardiovascular Medicine

Position Title:

Clinical Research Manager - Cardiovascular and Cardiothoracic Research Job Family Group:
Professional Staff Job Description Summary

The Clinical Research Manager oversees clinical research activities led by investigators and faculty within the assigned research program. This role plans, coordinates, and executes operational aspects of clinical research, including managing project timelines, budgets, contracts, agreements, and study deliverables. The Clinical Research Manager collaborates with principal investigators, research teams, and institutional partners to support successful study execution, develop and implement standard operating procedures, oversee administrative support functions, and improve research operations.

• Plan, coordinate and oversee all phases of clinical research studies including industry-sponsored, federally funded, investigator-initiated, and multi-site trials.
• Develop and manage study timelines, deliverables, budgets, contracts, and agreements to ensure projects are completed on time and within budget.
• Coordinate study start-up activities including regulatory submissions, contract execution, IRB approvals, ancillary approvals, credentialing, and site activation.
• Monitor project progress, identify risks, resolve operational issues, and implement solutions to support successful study execution.
• Collaborate with principal investigators, study teams, sponsors, contract research organizations (CROs), external study sites, and institutional partners throughout the study lifecycle.

• Develop, implement, and maintain standard operating procedures (SOPs), study manuals, source documents, case report forms, and other study documentation as appropriate.
• Assist with the development, review, and submission of research protocols, informed consent documents, and regulatory materials.
• Establish and oversee quality management activities, including monitoring study performance, recruitment, retention, data quality, protocol compliance, and corrective and preventive action (CAPA) plans.
• Track protocol deviations and support corrective actions to ensure compliance with institutional, sponsor, and regulatory requirements.
• Participate in internal and external audits, inspections, and quality improvement initiatives.

• Assist with study feasibility assessments, budget development and review, and financial oversight of assigned projects.
• Track project milestones and prepare operational and research progress reports for investigators, sponsors, and funding agencies.
• Support implementation and ongoing management of research systems and operational processes.

• Supervise and provide direction to assigned research and administrative staff including hiring, onboarding, orientation, training, and performance management as applicable.
• Provide mentorship, coaching, and operational guidance to study teams to promote collaboration, consistency, and efficient study execution.
• Coordinate staff assignments and cross-coverage to meet project and operational needs.

• Serve as the primary operational liaison among investigators, study teams, sponsors, CROs, research sites, laboratories, pharmacies, and institutional departments.
• Foster effective communication across internal and external stakeholders to support timely study activation, enrollment, and completion.
• Provide consultation and operational support to study teams to address project challenges and improve research processes.

• Perform clinical research duties, as needed, to support study operations at any level from Clinical Research Assistant through Clinical Research Supervisor, including participant assessments, informed consent, specimen processing, and protocol-required study procedures.

• Certification/Licenses:
  Research certification required such as Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Association of Clinical Research Professionals (ACRP).
• Ten (10) years of work experience in healthcare or research setting.
• Work experience with regulations governing clinical research (CFR, GCP, HIPAA) and statutes and guidelines relevant to regulatory affairs in clinical research.

• Education:
  
  Master’s degree in a health-related field.
• Six (6) years’ experience managing or…