Clinical Research Nurse III - Genitourinary Malignancies Branch
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Bethesda, MD, USA
- Start date
- May 31, 2019
View more
- Discipline
- Clinical, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
The Clinical Research Directorate (CRD) provides clinical research nursing support to the National Cancer Institute's (NCI's), Center for Cancer Research (CRC), Genitourinary Malignancies Branch (GMB).
KEY ROLES/RESPONSIBILITIES
- Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
- Drafts source documents to be used in new studies
- Aids with all aspects of the protocol lifecycle including initial IND submission, IRB submission, continuing review applications, protocols, protocol amendments, annual reports, and protocol inactivation with IRB and FDA.
- Creates and maintains an IRB database of approved amendment descriptions
- Assists the Principal Investigator in data collection (including patient specimens) and data analysis; the writing of interim reports, annual protocol reports, and scientific publications; the interpretation of research data for the protocol team; and with performing site visits
- Completes flow sheets and case report forms according to the provisions of approved investigational protocols
- Coordinates Clinical Trial Agreement requirements with applicable Clinical Research Oversight Managers (e.g., safety reporting requirements) and data management, if data is to be provided to third party at end of trial
- Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
- Assists in the management of patient files, copying and organizing research data
- Confirms the collection of appropriate patient samples per protocol schema
- Coordinates patient schedules and provide information for a successful visit to meet the required protocol procedures, data collection time points and nursing care
- Discusses toxicities experienced and drugs/dosages received by patient while at home
- Documents patient care via established guidelines
- Maintains communication with the patient's home physicians to ensure any ongoing home care is in accordance with the protocol guidelines
- Recognizes and supports the needs of data integrity and retrieval, and interpret needs appropriately for Principal Investigators, patients and other staff members
- Recruits and enrolls patients
- Assists/trains local study staff in explaining the protocol and tests/procedures to the study participants
- Ensures scientific quality and human subject's protection
- Collects and interprets data as specified by the investigators in support of the clinical trial including drug administration, toxicity, laboratory parameters and response interpretation
- Collects and maintains current regulatory documentation from numerous ongoing clinical trials
- Distributes test kits, coordinates outside specimens for testing and diagnostic purposes (including referring MDs, NIH labs and repositories) and log received samples in appropriate database
- Interacts with auditing and monitoring agencies to facilitate the exchange of data
- Manages and coordinate intramural and extramural sites participating in clinical protocols for which the Principal Investigator is the coordinating center
- Manages dose modifications and/or other modifications of the treatment regimen made in response to toxicity, pharmacokinetics, and tissue studies
- Manages the implementation, tracking, data abstraction, collection, data reporting and coordination of a variety of Phase III clinical trials
- Obtains informed consent
- Orders labs, x-rays and other diagnostic procedures prescribed by the protocol and/or clinically indicated
- Oversees ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations
- Participates in the management and evaluation of multiple international clinical protocols
- Works directly with investigators and medical writers on the production and revision of clinical research protocols and facilitate the activities of writing and regulatory review
- Works with site staff to put systems in place to ensure timely resolution of queries
- This position is location at the National Institutes of Health (NIH) in Bethesda, Maryland
BASIC QUALIFICATIONS
- Must possess a degree or diploma from a professional nursing program approved by a legally designated State accrediting agency at the time the program was completed
- Current State license as a registered nurse (RN)
- A minimum of one (1) year nursing and/or related clinical research experience
- Foreign degrees must be evaluated for U.S. equivalency
- Must be able to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
- Oncology experience
- Experience in a clinical trials outpatient setting and/or experience in data management and collection
- Experience in pediatric oncology, transplant and/or neuro-oncology
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Company
A rewarding career with global impact
Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.
Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.
We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.
Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.
Discover why joining the Frederick National Laboratory team could be the most important career step you take
- Website
- https://frederick.cancer.gov/
- Phone
- 301-846-1000
- Location
-
8560 Progress Drive
Frederick
MD
21701
US
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