Manager of Clinical Research Operations

McKesson•Orlando, FL

About The Position

As the Manager of Clinical Research Operations, you are responsible for management of clinical research operations that include nursing, pharmacy, laboratory and medical assistants to support enrollment through treatment and follow-up visits, and other tasks supporting care of clinical trial patients. Specific responsibilities include: Oversee and manage daily activities of clinical research nurse, enrollment nurse, medical assistant, laboratory technician, pharmacist and pharmacist technician Oversee enrollment of patients onto clinical trials through recruitment, screening, enrollment, on study treatment and follow up of eligible patients according to protocol requirements Oversee clinical trial related activities are completed by the clinical research team to ensure completeness and accuracy, as well as adherence Standard Operating Procedures Problem-solve daily clinical situations for the diverse clinical research team Ensures clinical team collaborates with Study Operations to resolve queries, SAEs, deviations and audit findings according to standard operating procedures, regulatory compliance and contractual sponsor obligation Escalate issues to leadership when necessary for timely resolution Track performance metrics and report monthly to leadership Attend mandatory meetings, site initiation and other meetings which will impact the delivery of quality research and compliance Ensure clinical team completes company provided and sponsor provided training timely Identify opportunities for improvement in processes and overall quality, monitors outcomes if deficiencies are identified Responsible for hiring, onboarding, and training of clinical research team Assist clinical research team in clinic as needed Meet with direct manager weekly to provide clinic summaries Meet with physicians and leadership to assess performance of clinic as needed Assist in development and tracking of quarterly goals for clinical research team Manage performance and professional development of clinical research team by conducting quarterly and annual performance reviews

Requirements

Associate Degree required
Registered Nurse License to practice in the state of Florida
At least one year of management experience
Knowledge of oncology/research operational and clinical proficiency
Knowledge of Good Clinical Practices (GCP)
Knowledge of research protocol interpretation, and SCRI organizational policies
General knowledge of research regulatory and Quality Assurance guidelines
Strong interpersonal, communication and organizational skills
Microsoft 365, Word, Excel, PowerPoint and overall computer systems
Ability to communicate and collaborate effectively with a diverse team of professionals internally and externally
Ability to self-direct, including prioritization of multiple simultaneous tasks to drive the navigation of clinical research patients
Resourceful with analytical abilities and problem-solving skills in a fast-paced environment

Nice To Haves

Bachelor Degree preferred
BLS certification preferred

Responsibilities

Oversee and manage daily activities of clinical research nurse, enrollment nurse, medical assistant, laboratory technician, pharmacist and pharmacist technician
Oversee enrollment of patients onto clinical trials through recruitment, screening, enrollment, on study treatment and follow up of eligible patients according to protocol requirements
Oversee clinical trial related activities are completed by the clinical research team to ensure completeness and accuracy, as well as adherence Standard Operating Procedures
Problem-solve daily clinical situations for the diverse clinical research team
Ensures clinical team collaborates with Study Operations to resolve queries, SAEs, deviations and audit findings according to standard operating procedures, regulatory compliance and contractual sponsor obligation
Escalate issues to leadership when necessary for timely resolution
Track performance metrics and report monthly to leadership
Attend mandatory meetings, site initiation and other meetings which will impact the delivery of quality research and compliance
Ensure clinical team completes company provided and sponsor provided training timely
Identify opportunities for improvement in processes and overall quality, monitors outcomes if deficiencies are identified
Responsible for hiring, onboarding, and training of clinical research team
Assist clinical research team in clinic as needed
Meet with direct manager weekly to provide clinic summaries
Meet with physicians and leadership to assess performance of clinic as needed
Assist in development and tracking of quarterly goals for clinical research team
Manage performance and professional development of clinical research team by conducting quarterly and annual performance reviews