Clinical Research Nurse III - ETIB

Location
Bethesda, MD, USA
Posted
Oct 30, 2018
Ref
req134
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Within the Leidos Biomedical Research Inc.'s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Research Directorate (CRD) provides clinical research nursing in support of the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Experimental Transplantation and Immunology Branch (ETIB).

KEY ROLES/RESPONSIBILITIES
  • Ensures adherence to current regulations, guidance, and policies that affect research at the institutional, state, federal and international levels
  • Ensures adherence to ethical practices during the conduct of clinical research studies in order to protect the rights and well-being of patients and the collection of quality data
  • Protects patient, protocol, and scientific confidentiality by ensuring security of research data and personal health information
  • Complies with the International Air Transport Association and institutional policies for shipping and receiving biological specimens
  • Collaborates with the research team to implement procedures for maintaining patient study participation from enrollment through completion
  • Identifies the Institutional Review Board (IRB) of record, protocol-related policies of the IRB and preferred contact method
  • Provides timely, informative, and accurate communication to the IRB as required
  • Facilitates and participates in the preparation and implementation of audits, 9) participates in the evaluation of audit data and establishment of corrective action plans
  • Ensures the validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and Serious Adverse Events (SAEs)
  • Collaborates with the Principal Investigator (PI), Laboratory of Pathology, and outside collaborators regarding feasibility of protocol implementation
  • Provides general clinical research as well as study-specific information to research, clinical, and other organizational staff (e.g., in-services, specimen coordination)
  • Participates in study initiation meetings
  • Ensures the initial and ongoing consent process is performed and documented in compliance with Food and Drug Administration (FDA), International Conference on Harmonization/Good Clinical Practice (ICH/GCP), institutional, sponsor, IRB, and other applicable regulations, guidance and policies
  • Participates in the development/dissemination of information describing the research study and ensures study patients are educated and aware of relevant new information that arises
  • Identifies barriers to effective informed consent discussions and implements plans to overcome them
  • Serves as a liaison to NIH and non-NIH participating healthcare providers regarding patients and referrals
  • Collaborates in providing information to all members of the Center for Cancer Research (CCR) healthcare team caring for a patient
  • Ensures adherence to the protocol schedule of events and other requirements
  • Ensures scheduling of all procedures required to assess for adverse events and disease response to the study intervention
  • Assesses patients for study-related and non-study related symptoms and ensures evidence-based symptom management while maintaining clinical research study compliance
  • Collaborates with the PI on adverse events and documents and reports findings per the protocol, FDA, sponsor, and IRB policies
  • Supports and evaluates patient adherence to the protocol
  • Identifies vulnerable patients who require increased nursing assessment and management in addition to the clinical research study requirements
  • Participates in screening potential new study participants
  • Coordinates and organizes study meetings (including the Clinical Genetic Incidental Finding Committee and Somatic Tumor Board) in collaboration with treating physician, Clinical Genetics ClinOmics team, external collaborators and other relevant specialists as indicated
  • This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
  • 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
  • Experience with adult patient populations
  • Prior research nurse experience with clinical trials in an outpatient setting
  • Data management and collection experience
  • Experience in the coordination, implementation, and execution of clinical trials
  • Ability to capture and analyze patient data including toxicity assessment, drug administration, laboratory results and tumor response
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:
  • Knowledge of bone marrow and stem cell transplant
  • Knowledge of basic behavioral science and counseling theory and principles
  • Knowledge of clinical research protocol design, development, interpretation, implementation and evaluation
  • Knowledge of the research process, including problem identification, literature review, proposing hypothesis, research data collection, statistical analysis of data and the recommendation of findings
  • Ability to apply knowledge to the clinical care of cancer patients
  • Credentialing in genetic nursing
  • Certified Clinical Research Coordinator (CCRC)

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)​​