McLean, Virginia, Mid-Atlantic Permanente Medical Group MAPMG is an Equal opportunity Employer. To learn more, view Equal Employment Opportunity is the Law in English or Equal Employment Opportunity is the Law in Spanish . We also participate in the E-Verify program , as required by law. MAPMG is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our job application procedures. If you need assistance or a special accommodation, you may contact us at Careersatmapmg@kp.org Job Category: Research Requisition Number: CLINI005386 Posted: 2022-09-01 Full-Time Tysons Corner Medical Center, 18015, 8008 Westpark Drive, McLean, VA, 22102, USA
Largo Med Center Upper Marlboro, 1221 Mercantile Ln, Upper Marlboro, MD 20774 Who We Are: The Mid-Atlantic Permanente Medical Group, (MAPMG) is one of the nation's premier multispecialty medical groups and is the largest integrated medical group in Maryland, Virginia and the District of Columbia. Founded in 1980, the medical group has more than 1,700 Permanente physicians spanning more than 50 subspecialties. Together, we serve approximately 800,000 Kaiser Permanente members in Maryland, Virginia, and the District of Columbia at 34 area medical centers, plus several community hospitals and skilled nursing facilities. Job Summary: We are seeking a Clinical Research Nurse to join the Mid-Atlantic Permanente Research Institute (MAPRI) team. 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.
This position has the flexibility to be based out of Tysons Corner Medical Center in Tysons Corner, Virginia or Largo Medical Center in Largo, Maryland. 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.
Qualifications:
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
Competitive Benefits:
Competitive compensation package
Comprehensive benefits including 100% employer-funded medical and dental insurance premiums for employees and families
Great work/life balance
Generous paid time off
Maternity and parental leave
Pension plan and 401(k) retirement plan
Life insurance, and short-term disability and long-term disability coverage
Education reimbursement
Equity, Inclusion, and Diversity: MAPMG continuously works to identify and mitigate healthcare inequities, and that starts with providing an inclusive, supportive environment for our physicians. We encourage applicants of any race, color, religion, sex, sexual orientation, gender identity, or national origin who value diversity and will commit to practicing culturally competent healthcare. We are proud to be an equal opportunity/affirmative action employer. We value our diversity and E/O/E M/F/D/V. Executive Order 11246 requires affirmative action and prohibits federal contractors from discriminating on the basis of race, color, religion, sex, sexual orientation, gender identity, or national origin. Contractors also are prohibited from discriminating against applicants or employees because they inquire about, discuss, or disclose their compensation or that of others, subject to certain limitations.
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