Clinical Trials Research Nurse Practitioner
Company: Medical Science
Posted on: June 8, 2021
We are currently searching for a Clinical Trials Research Nurse
Practitioner 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
- Assists Investigator and study team with the execution of
clinical trials and assures that all aspects of Good Clinical
Practice (GCP) and federal regulatory requirements are
- Assists study team with the evaluation of patients on the
natural history protocol and summarizes and discusses history, past
and present clinical evaluations that include, imaging studies,
lesional biopsies and immunological evaluations with clinical
- Schedules and organizes patient visits to NIH as needed
including international patients. Provides independent telemedicine
consultations consistent with the contractor's individual clinical
credentials, Clinical Center policies and specific clinical
guidance by the task leader specific to protocol requirements.
- Documents clinical and interim history of patients in CRIMSON
and conducts in person and virtual protocol visits (telephone and
virtual TCs) to collect structured data on natural history protocol
and on clinical trials.
- Assists with collection and entry of safety and efficacy data
and enterable laboratory data into databases maintained by the
- Interviews, screens and recruits patients for entry onto
natural history and interventional protocols including
international patients who require interpreters.
- Obtains informed consent/assent and addresses complex ethical
and legal implications of same as back up for study nurse.
- Works with study coordinator to oversee compliance to protocol
by developing and adhering to relevant SOPs; managing the quality
control, completion and submission of study related documentation;
preparing, submitting and maintaining IRB, FDA, and/or other
regulatory documents and research correspondence.
- Assists the study coordinator in providing training to clinic
staff with regard to Investigator Brochure information, protocol
implementation, general and specific data collection and research
- Collaborates with many of the following professionals and/or
organizations: pharmacy, laboratories, pharmaceutical
agencies/sponsors and monitors, and the Institutional Review boards
and IND holders.
- Performs 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.
- Assists with the collection, processing and handling of
laboratory samples including appropriate storage and shipping as
- Conducts educational presentations to nursing units, clinics
and other departments collaborating on clinical trials.
- Reports data to appropriate regulatory and monitoring agencies.
Anticipates and creates database/case reports to meet protocol
- Monitors study enrollment goals and initiates strategies to
promote enrollment and participant compliance. Coordinate and
perform responsibilities related to research participants including
determining subject population availability, developing informed
consents and screening materials, screening and recruiting
subjects, scheduling visits, obtaining informed consent and
overseeing study visits.
- Maintains study subject databases; supervises data collection
and management including the collection of source documents, using
and developing CRFs, and ensuring that they are complete and
- Prepares for and coordinates site visits made by sponsors or
study monitors during the course of and at the close of the
- Contributes to developing educational materials and educate the
community and other research professionals regarding studies and
related research issues.
- Uses advanced communication skills to problem solve complex or
unpredictable situations and to improve processes and services to
patients and colleagues
- Minimum of an R.N. and N.P. degree.
- Licensed as a nurse in the State of Maryland.
- Must be able to be credentialed by the Clinical Center.
- Knowledge of environmental safety, including infection control,
isolation technique, aseptic technique, and general security.
- Knowledge pertaining to privacy of the patient, privileged
information and secure handling of the patient's medical
- Knowledge of federal regulatory requirements pertaining to
- Knowledge of Good Clinical Practice (GCP)
- NIH clinical trials experience preferred
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
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 get
- 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.
Keywords: Medical Science, Bethesda , Clinical Trials Research Nurse Practitioner, Other , Bethesda, Maryland
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