(Closed) Clinical Research Nurse
Company: Mid-Atlantic Permanente Medical Group
Location: Gaithersburg
Posted on: April 16, 2024
Job Description:
Who We Are:
At the Mid-Atlantic Permanente Medical Group, more than 1,700
Permanente physicians and nearly 300 staff professionals come
together to make a positive impact on the health and lives of more
than 825,000 people who get their healthcare through Kaiser
Permanente. Serving a diverse community that spans Washington,
D.C., suburban Maryland, Baltimore, and northern Virginia, we are a
single group practice that offers an array of best-in-class
facilities, resources, and services at over 30 medical centers,
more than a dozen community hospitals, and several skilled nursing
facilities - all focused on creating an environment that empowers
our physicians to provide high-quality care.
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. Applicants must be local or willing to
relocate to the Washington D.C., Maryland, or Virginia area.
This position will be based out of the Kaiser Permanente
Gaithersburg Medical Center.
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 of three years of clinical nursing experience
- Minimum of 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:
At MAPMG, equity, inclusion, and diversity are at the core of our
organizational culture. MAPMG is proud to be an equal opportunity
employer and is committed to providing equal opportunity for all
employees and applicants. We continuously work to identify and
mitigate healthcare inequities, and that starts with providing an
inclusive, supportive environment for our employees. 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 to apply.
External hires must pass a background check and drug screening.
We are proud to be an equal opportunity/affirmative action
employer.
We value our diversity and E/O/E M/F/D/V.
Keywords: Mid-Atlantic Permanente Medical Group, Silver Spring , (Closed) Clinical Research Nurse, Healthcare , Gaithersburg, Maryland
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