BASIC FUNCTIONS The Clinical Research Nurse participates throughout the entire clinical trials study process. Specific responsibilities include preparing and submitting IRB and regulatory documents, collaborating with physicians to determine patient eligibility for clinical trials, discussing specific trials with potentially eligible patients, consenting and coordinating patients to be enrolled in specific clinical trials, and monitoring patients enrolled in clinical trials.
Additional responsibilities include assisting with the development, implementation, and evaluation of clinical trials for research by pharmaceutical companies, device manufacturers, collaborating institutions, cooperative groups, and internal investigator initiated studies. Some travel is required to investigator meetings, training sessions, and to Kaiser Permanente medical centers within the region.
RESPONSIBILITIES - Recruit and evaluate clinical study subjects, scheduling appointments and interviews. - Provide instruction to potential clinical study subjects and those involved in care of subjects on aspects of subject’s care, treatments, and side-effects. - Explain informed consent procedures and obtain written consent. - Educate subjects on diagnosis and treatment plan. - Facilitate test and procedure scheduling for subjects participating in clinical trials and/or treatment plans according to protocol design. - Perform essential subject assessment functions such as accurately obtaining vital signs and collecting biological specimens. - Perform procedures according to the protocol using proper technique, standard precautions, and following Good Clinical Practice guidelines. - Complete all source documentation and Case Report Form, maintain thorough and organized study documentation, including research records, phone logs, screening logs, and regulatory binders, and accurate drug accountability records. - Complete, submit, and maintain documentation required by Office of Human Research Protection and regulatory documentation required by Sponsor. - Adhere to protocol requirements; identify and implement strategies to prevent protocol deviations and violations. - Follow billing policies to assure proper billing for research- related services. - Coordinate and participate in monitor and regulatory visits, and manage timely responses to queries. e.g., corrective action plans. - Monitor subject responses to protocol and communicate findings to the physician and health care team; report adverse events to the PI and others as required by protocol. - Attend research meetings, staff meetings, conferences, and in-service education of nursing and medical staff. - Foster and maintain cooperative relationships with other departments, patients, medical staff, and sponsors. - Responsible for knowing and following all MAPRI SOPs, IRB SOPs, Kaiser Permanente policies and procedures, and Federal rules and regulations applicable to clinical research. - Prepare IRB documentation as required, including: initial submissions, protocol amendments, protocol modifications, Adverse Event Reports, protocol deviations, protocol violations, continuing review, and informed consent documents. - Obtain and prepare regulatory documents required to conduct clinical trials, including: investigator CVs, financial disclosure forms, laboratory certifications, radiation safety exemptions, FDA 1572 forms, etc.
- Licensed Nurse (RN) in jurisdiction to which assigned. - Research professional certification within 2 years of hire (e.g., Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP)). - DOT/IATA certification within one year of hire. - CPR certification. - Passing grade on Kaiser Permanente standard medication test. - Minimum three years of clinical nursing experience. - Minimum one year of related work experience in clinical trials research - Detailed knowledge of research rules and regulations and Good Clinical Practice (GCP) guidelines - Proficient with word processing and spreadsheet applications, and other software applications unique to the MAPRI - Strong project management and organizational skills - Strong written and oral communication skills * Ability to work with minimal supervision and in self-directed manner * Ability to maintain meticulous records for clinical trials and research projects, including case report forms, regulatory documents, correspondence, etc. - Ability to interact on a scientific level with medical staff, physicians, and representatives of national and pharmaceutical groups - Ability to collaboratively assure protocol compliance and completion
Welcome to The Mid-Atlantic Permanente Medical Group. Kaiser Permanente is as well known for setting standards in care excellence as the Mid-Atlantic region is known for its national landmarks and attractions. We invite you to explore the countless ways The Mid-Atlantic Permanente Medical Group can help you and your practice thrive.
At the Mid-Atlantic Permanente Medical Group, the trusting rel...ationship between skilled doctors who care about and for their patients is central to the way we practice medicine. We lead the nation in preventive care for adults and children. We excel in health education, early detection, and careful management of chronic diseases. Patient care decisions are yours.
Permanente physicians from across the country share best practices regarding the most effective medical care, new developments in research, and the latest medical technologies. In our communities, our physicians appear regularly in top physician lists in magazines such as Washingtonian, Baltimore Magazine, and the Washington Consumer Checkbook. Our physicians respect diverse cultures and lifestyles.
Many of our physicians hold academic appointments at universities and hospitals, and serve on health-related boards and committees. We will encourage you to join your colleagues who participate in research studies with partners such as NIH, Johns Hopkins and other medical facilities as well as Kaiser Permanente's own Division of Research.
Five key elements - Prevention, Excellent Care, Top Doctors, Compassion, and Innovation - exemplify our integrated care delivery model.