The CRN position with Kaiser Permanente 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.
This part time position has additional responsibilities that include assisting with the development, implementation, and evaluation of clinical trials for research by collaborating institutions, cooperative groups, pharmaceutical companies, device manufacturers, and internal investigator-initiated studies. Some travel is required (investigator meetings/training and to Kaiser Permanente medical centers within the region). CRN also will develop outcome measures and quality evaluation of pediatric and adult clinical care programs, under the leadership of MAPRI investigators and MAPMG clinical leadership.
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 and clinical 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.
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.
Develop clinical outcome measures and derive such measures for evaluation of MAPMG and KPMAS clinical programs in pediatrics and adult medicine, under the leadership of MAPRI and MAPMG investigators and leadership.
Create appropriate reports for MAPMG clinical leadership.
Licensed Nurse (RN) in jurisdiction to which assigned or Bachelor’s degree in related sciences.
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.
Passing grade on Kaiser Permanente standard medication test, if applicable.
Minimum three years of clinical nursing experience or five years of clinical research coordinator 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.
SETTING STANDARDS FROM THE START
In 1948, seven physicians got together to create a new kind of medical group, one that focused on collaboration, put the patient at its core and provided a truly integrated health care delivery system. The result was a practice and approach that grew to become a gold standard in healthcare.
More than 30 years later and over 1,200 physicians strong, MAPMG and its ...integrated health care delivery model continue to forge new territory in medicine. As the quality leader in our industry, we help over 600,000 members throughout DC, MD, and VA live healthier, happier lives. And we do the same for our physicians.
BALANCED LIVING IN PRACTICE
As part of our team, you’ll enjoy comprehensive administrative support, cross-specialty collaboration, easy access to resources and more. You’ll also enjoy a balanced schedule, so you can make the most of your time here and at home. Most importantly, you’ll have the professional autonomy you need to do what you do best: provide truly exceptional care for your patients.
OUR FACILITIES, PROGRAMS & AFFILIATIONS
MAPMG boasts 30 medical office buildings throughout DC/Suburban Maryland, Baltimore, and Northern Virginia, and affiliations with several top hospitals in the region including Greater Baltimore Medical Center and Holy Cross Hospital.