Sr. Manager, Research Support

University of Miami•Miami, FL

8d•Onsite

About The Position

The Sr. Manager, Research Support leads research program teams and oversees the day-to-day operations and resources of research staff, including supporting their growth and development. At the University of Miami’s Sylvester Comprehensive Cancer Center (SCCC), the role manages Clinical Research Services (CRS) staff assigned to multiple Site Disease Groups (SDGs), supporting a portfolio of more than 125 protocols and approximately 700 ongoing clinical research patients. The position manages services to 16 SCCC-specific SDGs and oversees studies in neuro-oncology, sarcoma, and pediatrics. The manager leads clinical research coordinators and data managers and communicates with sponsors and investigators throughout the study lifecycle, from study offering through closeout. The role oversees recruitment, hiring, performance management, staff training, workload assignment, protocol implementation, quality reviews, audits, and corrective actions. It develops and maintains systems, processes, policies, procedures, and standard operating procedures in coordination with regulatory, financial, and quality assurance colleagues. The manager ensures research activities comply with protocols, sponsor requirements, federal regulations, Good Clinical Practice guidelines, and University policies and procedures. The position also supports operational and technical functions, department budgeting, manuscript preparation, data analysis, and development of indicators for a data visualization platform.

Requirements

Bachelor’s degree in nursing, healthcare, or another related field.
More than five years of work-related experience, including supervisory experience.
Three years of experience in site management of clinical trials.
Must hold at least one of the following certifications: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), Certified Clinical Research Professional (CCRP), and/or Oncology Research Nurse Certification.
Excellent knowledge of the Code of Federal Regulations and Good Clinical Practice.
Excellent skills with general computer applications, including Word, Outlook, Excel, Adobe, and electronic data capture systems.
Ability to be trained in specialized database and statistical programs.
Excellent English verbal and written communication skills.
Knowledge of business and management principles.
Ability to direct, manage, implement, and evaluate department operations.
Ability to establish department goals and objectives that support the strategic plan.
Ability to plan effectively, delegate, and supervise the work of others.
Ability to lead, motivate, develop, and train others.

Nice To Haves

Master’s degree preferred.
Experience conducting quality assurance reviews and data analysis preferred.

Responsibilities

Lead and coordinate research staff and ensure their functions are completed accurately and on time.
Oversee day-to-day operations, resources, and services of CRS clinical research staff assigned to multiple Site Disease Groups.
Recruit, screen, interview, hire, train, counsel, and evaluate clinical research staff; prepare performance reports and disciplinary recommendations as appropriate.
Manage continuing education and professional development for staff, including licensing, certifications, training, CEUs, in-services, lectures, workshops, and external conferences.
Train staff and ensure compliance with protocols, CRS SOPs, sponsor requirements, federal regulations, Good Clinical Practice guidelines, and University policies and procedures; monitor training effectiveness and address noncompliance with follow-up training.
Work with regulatory and financial managers to develop and maintain CRS SOPs and create staff orientation manuals and supporting systems, processes, policies, and procedures.
Review new studies and manage clinical protocol design, development, and preparation for implementation; coordinate with Quality Assurance staff to ensure required systems and processes are in place before implementation.
Ensure clinical research tasks are performed according to protocol, sponsor requirements, regulations, Good Clinical Practice guidelines, and University policies; respond to variances and implement corrective actions.
Manage audits and communications with sponsors and outside agencies.
Assign staff workloads and conduct quality reviews of staff performance as needed and required by University policy to support patient safety and adequate protocol monitoring.
Provide technical support and resolve operational problems.
Oversee the department budget and identify opportunities for cost reduction.
Assist with preparation and publication of manuscripts.
Analyze reports, data briefs, and auxiliary publications for new topic modules.
Define and produce indicators for a data visualization platform.
Establish and assess internal controls, ensure compliance with University policies and procedures, and train employees on controls and applicable policies.
Manage study portfolios in neuro-oncology, sarcoma, and pediatrics, and communicate with sponsors and investigators from study offering through closeout.