Under general supervision, coordinates the implementation of research protocols approved for activation by the Mercy Medical Center IRB. Reports to the Director of Operations and is directed by the Principal Investigators of the various clinical trials.
POSITION SPECIFIC COMPETENCIES * Assists clinical investigator with study initiation, conduction, and completion by: o Maintains regulatory compliance by Communicating with the Institutional Review Board and maintaining regulatory binders and/or digital files, prepares and submits protocol specific requirements to the IRB. o Confirming appropriateness of drug doses in accordance with protocols. o Acting as a consultant to members of the MMC health care team. Support Oncology research and tumor specific patient tracking as requested. o Communicating treatment modifications and amendments to PI and staff. o Preparing study results for presentations and/or publication. * Will communicate with the clinical trial financial management staff to identify protocol events that require invoicing to the Sponsor. Will maintain established financial tools to assist in billing practices. * Acts as liaison between MMC and the study sponsor by preparing study reports and communicating with clinical study monitors. * Maintains clinical database files on participating patients in clinical trials and/or those patients seen by a specific clinical service. * Participates in the conduction of clinical research studies: Screens patients for eligibility to enter research studies. Ensures that diagnostic tests required to enter a study are ordered and performed. Assists physicians and/or principal investigators in obtaining informed consent from patient participants. Conducts patient/family education concerning clinical studies. Administers investigational drugs as required by treatment protocols. Follows the clinical course of patients entered into clinical research studies by obtaining results of diagnostic studies, assessing patients for complications, and recording patient data onto study forms or into a database. Obtains clinical samples from patients as needed and prepares samples for processing. Records pertinent patient information on flow sheets and other case report forms. * Attends and participates in various in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development. * Represents the Cancer Program at research and protocol initiation meetings. * Prepares for and represents the research team at internal cancer conferences. * Prepares for and responds to audits conducted by study sponsors. This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Registered Nurse License in the Maryland (renewable each year)
Must possess a high school diploma or GED.
Bachelor's Degree in Nursing preferred.
3 years in direct patient care nursing and 1 year in clinical trial research preferred.
Oncology experience preferred.
Computer proficiency and technical aptitude with the ability to utilize one or more of the following:
Microsoft Word Power Point Excel Microsoft Outlook Meditech (if applicable to position)Epic (if applicable to position) Performance Manager/NetLearning
Must be able to read, write, and speak the English language in an understandable manner.
Must be able to work independently and possess the ability to make independent decisions when circumstances warrant such action.
Must possess the ability to effectively communicate and deal tactfully with other personnel, visitors, patients, physicians, customers, and the general public.
Must be flexible, have personal integrity, and the ability to function effectively as a team with other employees.
Must be able to follow written and oral instructions.
Must possess knowledge of the principles and growth and development over the participating patients' life span.
Must have the ability to assess data reflective of the patient's requirements relative to his/her age-specific needs.
Knowledge of medical terminology, anatomy, and physiology at a level normally acquired through completion of approved training programs.
Ability to work in a demanding and challenging environment Supports the team effort through a willingness to work beyond normal working hours.
Must have excellent telephone demeanor.
Must possess and promote excellent health, hygiene and grooming habits. Ability to prioritize work load for the most efficient performance.
Internal Number: 1
About Mercy Medical Center
Like the Sisters of Mercy before us, we witness God’s healing love for all people by providing excellent clinical and residential services within a community of compassionate care.