Sr. Manager, Research Support

University of Miami•Miami, FL

9d•Onsite

About The Position

The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Sr. Manager, Research Support to work at the UHealth medical campus in Miami, Florida. The Sr. Manager, Research Support leads the research program teams to ensure successful system implementation and upgrades. Specifically, the Sr. Manager, Research Support oversees the day-to-day operations and resources of research staff and supports programs for their growth and development. The Individual will be responsible for the day-to-day management of Clinical Research Services (CRS) clinical research staff who are assigned to multiple site disease groups (SDGs). Management would include the oversight of over 125 clinical research protocols, which have resulted in the accrual of over 250 patients in the last year. Subsequently, the CRS clinical research manager will manage approximately 700 ongoing clinical research patients. The CRS clinical research manager would manage the day-to-day interactions and subsequent services CRS clinical research staff provides to the sixteen SCCC specific Site Disease Group’s (SDG’s). The candidate will be managing the portfolio of studies for neuro-oncology, sarcoma, and pediatrics. The candidate will manage a staff of clinical research coordinators and data managers. The candidate will communicate with sponsors and Investigators during the entire process from study offering to close out.

Requirements

Bachelor’s degree in relevant field
Minimum 5 years of relevant experience
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 effectively plan, delegate and/or supervise the work of others.
Ability to lead, motivate, develop, and train others.
B.S. degree in Nursing, Healthcare or another related field required.
More than five years of work-related experience, including supervisory experience and three years’ experience in the site management of clinical trials.
Must have obtained 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.
Must have excellent knowledge of the Code of Federal Regulations and Good Clinical Practice.
Must have excellent skills in general computer applications (e.g., word, Outlook, Excel, Adobe, various electronic data capture (EDC) systems).
Must have the ability to be trained in specialized database and statistical programs.
Excellent English skills (both verbal and written) required.

Nice To Haves

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

Responsibilities

Conducts meetings with research staff and ensures functions are coordinated in a timely and accurate manner.
Provides technical support and resolves operational problems.
Oversees department budget and identifies areas of opportunity for cost reduction.
Assists in the preparation and publication of manuscripts.
Recruits and trains research staff and prepares performance reports and disciplinary recommendations for the leadership team.
Analyzes reports, data briefs, and auxiliary publications for new topic modules.
Defines and produces indicators for a data visualization platform.
Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures.
Manage multiple CRS clinical research staff assigned to Site Disease Groups (SDGs).
Individual will be responsible for clinical research team recruitment, screening, interviewing, hiring, performance evaluations, counseling, etc.
Manage the initiation of continuing educational programs for CRS clinical research staff, including the facilitation of the clinical research staff licensing, certifications, training, Continuing Education Units (CEUs) through the use of in-services, guest lectures, workshops and other in-house seminars. Ensure clinical research staff participate in outside educational conferences and workshops as warranted.
Perform all necessary clinical research staff training to ensure compliance with the protocol, CRS Standard Operating Procedures (SOPs), sponsor requirements, the federal regulations, Good Clinical Practice guidelines and UM policies and procedures.
Work with the Regulatory Manager and Financial Manager in the development and maintenance of the CRS SOPs. Create clinical research staff orientation manuals, implement necessary systems, processes, and procedures for the support of clinical trials research. This includes overseeing the creation and maintenance of policies and procedures as they relate to regulatory affairs, quality assurance, financial affairs, and all affiliate networks.
Performs all CRS clinical research staff training. Ensures the implementation of training is implemented into daily research procedures. Assess and monitor the implementation of the training and identify noncompliance. Performs follow-up training as required.
Review all new studies and manage the creation of the clinical protocol design, the protocol’s development, and its preparation for implementation. Working with Quality Assurance staff, ensure all required systems and processes are in place prior to a new protocol’s implementation.
Ensure all clinical research duties/tasks performed by clinical research staff are implemented/performed as per the requirements of the protocol, sponsor requirements and guidelines, the federal regulations and Good Clinical Practice guidelines and UM policies and procedures.
Independently responds to any variance and implements corrective actions. Manages all audits. Manages all communication with the sponsor and outside agencies as required.
Perform and manage the assignment of workload to clinical research staff.
Perform quality review of clinical research staff performance. Reviews will need to be performed as needed and as required per UM policy to ensure patient safety and adequate monitoring of protocols.