An Oncology Clinical Research Manager must have a broad set of skills spanning oncology knowledge, clinical research expertise, project management, communication, and leadership. The ability to juggle multiple responsibilities and communicate across diverse teams and stakeholders is key to successful trial execution. The role requires both a scientific mindset and strong operational skills to ensure that oncology studies are conducted effectively, safely, and in compliance with all regulations.
In addition to working as a clinical research coordinator on assigned trials managed a team of clinical research coordinators. This role involves leadership, training and support of staff, ensuring compliance with study protocols and GCP while providing guidance on a daily basis.
Responsible for management of oncology clinical trials. Including coordinating day to day operations of clinical trials including patient recruitment, screening, enrollment and follow up. Maintaining study documentation in compliance with GCP and institutional standards. Also, responsible for communicating effectively with patients, explaining study procedures, obtaining informed consent and answering any questions regarding the clinical trial. Scheduled patient visits diagnostic tests and treatments ensuring smooth coordination of any trial related activities. Monitored patients throughout the study process, tracked adverse events and kept the PI informed of any changes.
Responsible for obtaining precertification for scheduled outpatient procedures and diagnostic tests.
Responsible for reviewing documentation of home health care clinicians to ensure all documentation meets the quality standards of Methodist Alliance and all Medicare requirements to ensure accurate payment. I was responsible for communicating needed improvements to field staff and following up to ensure all documentation is accurate and complete. In addition I assisted in providing additional education to field staff as needed.
Responsible for the skilled nursing care of homebound patients. This position required the ability to work independently to deliver wellness and illness care in varied home environments. Responsible for collaborating with physicians, therapists and other skilled professionals to coordinate high quality patient care. This position required the ability to work with little supervision, attention to detail, and meticulous documentation of the care provided in the home environment.
Responsible for the nursing care of patients requiring substantial specialized judgment and skill. This judgment and skill was based on knowledge of the natural, behavioral, and nursing sciences and humanities as the basis for application of the nursing process in wellness and illness care. This position required skill and proficiency in applying highly technical principles, concepts and techniques which are central to the professional discipline of nursing
Ability to manage timelines, budgets, and resources for clinical trials while ensuring compliance with regulatory requirements
Managing multiple studies simultaneously and adjusting priorities as needed
Providing training and guidance to junior staff and investigators on clinical trial protocols and procedures
Familiarity with global regulatory standards, such as ICH-GCP (International Council for Harmonisation - Good Clinical Practice), FDA, EMA, and other health authority requirements