Clinical Research Coordinator - NIH - LAD
Company: Regional Recreation Corporation of Wood Buffalo
Posted on: April 8, 2021
Clinical Research Coordinator - NIH - LAD in Bethesda, Maryland
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Clinical Research Coordinator - NIH - LAD Job Locations
US-MD-Bethesda # of Openings 1 Category NIAID Type Regular
Full-Time Overview CAMRIS is a clinical and life sciences firm that
realizes innovative solutions to challenges worldwide through
high-quality, cost-effective program and research management
services. We combine our proven systems with today's most
effective, evidence-based best practices to improve the lives of
people around the world.--Our core practice areas include HIV/AIDS,
microbiology and infectious disease research, vaccine research,
development and production, global health security, bio-defense,
and clinical research. CAMRIS attracts the next generation of
scientists to work at premier government research and development
institutions with state-of-the-art facilities and equipment, under
world leaders in health research. Our exceptional benefits package
that includes medical, dental and vision coverage, 401k plan with
employer contribution, paid holidays, vacation, Medical and
Flexible Spending Accounts, and life insurance. If you enjoy being
a part of a high performing health and research organization
dedicated to making the world a healthier place, please apply
today! We are seeking a Clinical Research Coordinator to support
the overall functions of the Laboratory of Allergic Diseases (LAD),
Allergy Research Unit (FARU) at the National Institutes of Health
- Provide advanced expertise in clinical trial coordination and
implementation, data and protocol
management. Oversee the implementation, tracking, data abstraction
and collection, data
reporting, and coordination of a variety of clinical trials in
affiliation with the NIAID/DIR
- Interview, screen and recruit patients for entry onto
- Ensure that families of participants are properly consented and
understand implications of genetic
research. Screen patients, obtain medical history, and acquire
outside medical records and
pathology specimens, while addressing complex ethical and legal
- Perform, and/or coordinate the collection, processing and
handling of laboratory samples
including appropriate storage and shipping.
- Coordinate the procurement of samples from referring physicians
worldwide to further the
- Monitor response to therapy and adjusts plan of care per
protocol specifications, standards of
practice, and other guidelines.
- Use sound judgment and clinical expertise to adjust patients'
plans of care in the absence of
- Document informed consents in CRIS and CRIMSON patient medical
- Manage protocols relating to human subjects research and the
collection and processing of
human samples procured under the auspices of NIH IRB-approved
clinical research protocols.
- Work to maintain NIH IRB protocol and office files, databases,
and records. Provide
administrative and technical guidance to investigators and
institute staff on NIH IRB functions.
- Maintain strict compliance with IRB, NIH and Federal
Regulations governing human subjects
- Stay current with NIH IRB requirements. Prepare reports and
respond to outside inquiries and
audits from IRB oversight and regulatory offices including, but not
limited to, the NIH
Intramural Research Program's Human Research Protections Program,
the NIH Office of Human
Subjects Research Protections, and the HHS Office of Human Research
- Educate investigators and staff and assures that all NIH IRB
policies and procedures are
disseminated to supervisors and other appropriate program staff via
written and electronic
- Provide training to clinic staff with regard to Investigator
Brochure information, protocol
implementation, general and specific data collection and research
- Direct health care members in the execution of trials and
resolution of logistical constraints and
assures all aspects of Good Clinical Practice (GCP) and federal
regulatory requirements are met
- Educate families on basic concepts of the human immune system
and hereditary disease as it
relates to their illness.
- Establish rapport and works with families under stress, provide
emotional support and refers to
- Process and guide research protocols through the review cycle
of submission, initial review,
continuing review, amendments, and reporting. Obtain translations
of protocol consents into
various languages and updates translated consents as needed.
Arrange for translators in advance
of protocol visits.
- Assist in preparing and analyzing clinical data for publication
in biomedical journals.
- Serve as a primary contact point for the Laboratory for
protocol procedures and regulations.
- Provide administrative and technical guidance for new
- Conductseducational presentations to nursing units, clinics and
other departments collaborating
on NIAID clinical trials.
- Ensure compliance with training for protection of human
subjects, conflict of interest guidelines,
and patient confidentiality. Ensure accurate and timely entry of
data to bio-specimen databases.
- Maintain integrity of databases by conducting periodic audits
and reports to Laboratory chief.
- Provide advice and expertise to technicians on maintaining
Clinical Laboratory Improvement
Amendment (CLIA) certification for the Laboratory where appropriate
and participates in CLIA
- Serve as a primary contact point for the Laboratory in regard
to protocol procedures, regulations
and requirements. Serves as the liaison between various individuals
and offices involved in the
oversight of human subjects research at the NIH including, but not
limited to, the NIH IRB, the
NIAID Clinical Director, the Office of Human Subjects Research, the
NIH Office of Clinical
Research, NIH Clinical Center Office of Protocol Services, Deputy
NIAID's Technology Transfer and Intellectual Property Office
(TTIPO), and investigators.
- Serve as the liaison between Laboratory and other teams in
NIAID, clinical nursing staff, NIH
Clinical Center Staff, other institutes and centers of the NIH,
extramural collaborators, referring
physicians, patients and their families.
- Participate in the development and maintenance of hard copy and
electronic systems to prepare,
monitor and track protocols and submissions. Participate in the
development and maintenance of
systems used to manage databases and to monitor compliance with
Maintain files and records on all protocols for the required
periods of time.
- Creatively solve problems related to obtaining viable patient
samples from international locations
and from patients with limited resources.
- Collaborate with many of the following professionals and/or
laboratories, pharmaceutical agencies/sponsors and monitors,
Contract Research Organizations,
the Food and Drug Administration, and the Institutional Review
boards and IND holders.
- Direct and perform quality assurance and quality control
activities as they relate to protocol
adherence, protocol monitoring, data collection, data abstraction,
and data analysis and assures
standard operating procedures reflect the highest standards of data
integrity and patient safety.
- Report data to appropriate regulatory and monitoring agencies.
Anticipates and creates
database/case reports to meet protocol needs. Translate data
collection needs into clinic wide
standards and tools, collaborating with resources beyond the
intramural setting to maintain data
- Pursue activities to facilitate the ease of reporting,
avoidance of repetition of data entry
procedures, and generation of reports appropriate to various
- Design and maintain a selection of material appropriate to send
to health care referral sources
seeking eligibility information or for other appropriate
- Analyze data, note trends and implications of same, publishes
and presents finding locally,
nationally and internationally representing NIAID and DIR.
- Serve in formal or informal leadership positions and is
recognized as an expert in a clinical or
research specialty area. Serves as a consultant and role model for
collaboration and communication.
- Use advanced communication skills to problem solve complex or
unpredictable situations and to
improve processes and services to patients and colleagues.
- Write expert documents relevant to research, clinical care and
related subjects including
published works and executive reports.
- Act as a mentor to students and nurse specialists/practitioners
new to the NIAID/ NIH Clinical
Center environment. Provide formal education to others in the field
of expertise including
lecturing at colleges and continuing education programs.
- Participate in clinical practice and research support peer
review and develops multidisciplinary
performance improvement programs and projects. Maintain an overview
of the clinical program
in order to collaborate and contributes to planning and resource
- Collaborate with peers and other multidisciplinary team members
to analyze and evaluate current
systems of health care delivery and to identify and implement new
practice patterns as
appropriate. Participate in outside activities that enhance
personal and professional growth and
- All support positions required a minimum of a BS degree; some
require a MS, MD, or Ph.D.
- The education, skills and relevant years of experience required
for each support position
are consistent with those identified as the minimum requirements
for the labor categories
specified in the contract.
- Thorough and comprehensive knowledge of the purpose and
function of IRBs and regulations
governing IRBs, including 45 CFR part 46 and 21 CFR part 56.
Thorough knowledge of NIH
OHSR IRB standard operating procedures, and other policies
regarding IRB review and human
subject research safety.
- Clinical Research Coordinator:
- Must have BSN or MSN degree, and a valid Nursing license.
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Keywords: Regional Recreation Corporation of Wood Buffalo, Bethesda , Clinical Research Coordinator - NIH - LAD, Healthcare , Bethesda, Maryland
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