Clinical Research Nurse III - Developmental Therapeutic Clinic
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Bethesda, MD, USA
- Start date
- Sep 11, 2019
View more
- Discipline
- Clinical, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
KEY ROLES/RESPONSIBILITIES
The Clinical Research Directorate (CRD) provides clinical research nursing support to NCI's Division of Cancer Treatment and Diagnosis, specifically to the Developmental Therapeutic Clinic.
- Serves as liaison between clinical and laboratory personnel and the NCI Developmental Therapeutics Principal Investigators
- Participates in clinical trials protocol development
- Develops procedure manuals for clinical trials protocols
- Assists in the creation of case report forms
- Advises on and participates in the management and evaluation of multiple clinical protocols
- Oversees ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations
- Interfaces with the Protocol Support Office
- Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
- Interacts with auditing and monitoring agencies to facilitate the exchange of data
- Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
- Monitors and oversees activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials
- Ensures quality and human subjects protection
- Assists with writing protocols and protocol amendments to ensure regulatory requirements
- Assists the Principal Investigator in interpreting research data for dissemination to the protocol team
- May conduct updates for clinical staff on patient care, protocol process and progress, human subject's protection, ICH Good Clinical Practices, and quality assurance education
- May visit off-site collaborative centers
- Work is performed independently under the general guidance and direction of the supervisor
- This position is located 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).
- Foreign degrees must be evaluated for U.S. equivalency
- A minimum of one (1) year nursing and/or related clinical research experience
- Oncology and regulatory experience
- Knowledge of clinical research data collection and clinical data report preparation
- Demonstrated experience in the coordination, implementation, and execution of clinical trials
- Ability to work in a data management setting in the capture and analysis of patient data including toxicity assessment, drug administration, laboratory results, and tumor response
- Must be able to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
- Experience in a clinical trials outpatient setting and/or experience in data management and collection
- Good communication skills
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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