Clinical Research Coordinator
Company: Regional Recreation Corporation of Wood Buffalo
Posted on: April 5, 2021
Careers - MSC - Clinical Research Coordinator in Bethesda,
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Candidate? Log back in! Clinical Research Coordinator Job ID
2021-9945 # of Openings 1 Job Location(s) US-MD-Bethesda Posted
Date 3 days ago (3/12/2021 3:22 PM) Category Science, Research &
Regulatory Overview We are currently searching for a Clinical
Research Coordinator to provide support to the National Institutes
of Health (NIH). This opportunity is a full-time position with MSC,
and it is on-site in Bethesda, MD. Duties & Responsibilities
- 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 program.
- 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
- Coordinate the procurement of samples from referring physicians
worldwide to further the laboratory's research.
- Monitor response to therapy and adjusts plan of care per
protocol specifications, standards of practice, and other
- Use sound judgment and clinical expertise to adjust patients'
plans of care in the absence of established guidelines.
- Document informed consents in CRIS and CRIMSON patient medical
- Manage protocols relating to human subject's research and the
collection and processing of human samples procured under the
auspices of NIH-approved clinical research protocols.
- Work to maintain NIH protocol and office files, databases, and
records. Provide administrative and technical guidance to
investigators and institute staff on NIH functions.
- Maintain strict compliance with NIH and Federal Regulations
governing human subject's research.
- Stay current with NIH requirements. Prepare reports and respond
to outside inquiries and audits from program oversight and
- Educate investigators and staff and assures that all NIH
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 practices.
- 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 or exceeded.
- 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 appropriate resources.
- 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
- Conduct educational presentations to nursing units, clinics and
other departments collaborating on 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
- 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 subject's research at the NIH.
- Serve as the liaison between Laboratory and other teams,
clinical nursing staff, 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
applicable regulations. 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
- Collaborate with many of the following professionals and/or
organizations: pharmacy, 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 collection tools.
- Pursue activities to facilitate the ease of reporting,
avoidance of repetition of data entry procedures, and generation of
reports appropriate to various agencies.
- Design and maintain a selection of material appropriate to send
to health care referral sources seeking eligibility information or
for other appropriate objectives.
- Analyze data, note trends and implications of same, publishes
and presents finding locally, nationally and internationally
representing the program.
- 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 professional practice,
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
- Act as a mentor to students and nurse specialists/practitioners
new to the program 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 development. Requirements
- Must have BSN or MSN degree, and a valid Nursing license.
- Minimum three (3) years direct experience in a clinical or
patient care environment.
- Knowledge of the basics of the clinical trial process
- Experience collecting and organizing data for reporting and
maintaining patient records.
- Exceptional interpersonal skills and communication skills, both
oral and written.
- Strong organizational skills. Able to work independently or as
part of a team. Company Description We are a trusted government
partner that blends deep domain expertise with advanced
technologies to help our customers solve complex problems that
improve, protect, and save lives. As a rapidly growing company, we
combine entrepreneurial spirit, customer focus, and an
outcomes-based approach to support agency missions in health IT,
life sciences, public safety, and grants management. The Dovel
Family of Companies offers employees--an opportunity to advance
beyond a specific role or contract, we--offer a path to develop an
enriching career.--We believe--in empowering a culture of
innovation, customer success, and employee growth. What you'll
- Time Off! Flexible schedules and company paid holidays allow
you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to
keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options
like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs,
we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care
Flexible Spending, HSA with company contributions, parking, and/or
transit commuter benefits.
- Support! Working parents and busy professionals - we've got you
covered with a supportive culture, confidential Employee Assistance
Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs,
company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and
have your voice heard. We are an Equal Opportunity Employer with a
commitment to diversity. All individuals, regardless of personal
characteristics, are encouraged to apply. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, gender, sexual orientation, gender identity,
disability, or veteran status. Options Apply for this job online
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Keywords: Regional Recreation Corporation of Wood Buffalo, Bethesda , Clinical Research Coordinator, Healthcare , Bethesda, Maryland
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