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.
- 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.