CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator), CCRP (Certified Clinical Research Professional)
Academic / Research
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.
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.
The Mid-Atlantic Permanente Research Institute (MAPRI) is the research department of the Mid-Atlantic Permanente Medical Group, PC, (MAPMG) and Kaiser Permanente Mid-Atlantic (KPMAS), serving approximately 500,000 members at 31 Kaiser Permanente Medical Centers in the District of Columbia (DC), Maryland, and Northern Virginia. MAPRI is located on the third floor of Kaiser Permanente’s Regional Off...ices in Rockville, Maryland, within the Mid-Atlantic Permanente Medical Group. MAPRI’s mission is to address the clinical, health policy, and service questions perplexing MAPMG providers, the medical program, and the healthcare system, aiming to improve the care experience of our patients and communities we serve.
MAPRI has four research scientists and over 15 affiliated clinician researchers, in various clinical fields and disciplines. Additional department resources include grant administration support, data managers and analysts, clinical research nurses and assistants, and biostatisticians. MAPRI offers expertise in health services research, including health disparities and economic impact of healthcare, epidemiology, health information technology, disease specific research in infectious diseases (including HIV/AIDS and hepatitis) and oncology, and clinical trials, all within a racially and ethnically diverse population. Currently, MAPRI is developing the following registries:
In addition, collaborative ties exist with various local institutions, including Johns Hopkins and Georgetown Universities, as well as other organizations across the U.S., including other Kaiser Permanente research units and the HMO Research Network (HMORN), Cancer Research Network (CRN), and the FDA Mini-Sentinel Initiative.