Protocol Nurse Coordinator II/III
3 weeks ago
Protocol Nurse Coordinator II/III
Job ID: req4058
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., the Clinical Research Directorate (CRD), various clinical support teams provide 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 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), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) 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, CRD services include comprehensive clinical trials monitoring, 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. CRD'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 nursing support services for clinical research being conducted within the National Institutes of Allergy and Infectious Diseases' (NIAIDs) Division of Intramural Research's (DIR), Laboratory of Immunology and Microbiology (LCIM).
KEY ROLES/RESPONSIBILITIES
Provides protocol management to an assigned caseload of research protocols (including, but not limited to):
Ensures compliance with regulatory requirements
Develops protocol procedure manuals
Manages clinical protocols
Obtains consent for clinical trial enrollment
Confirms eligibility of volunteers for participation in clinical trials
Communicates with patients and referring providers about the protocol and enrollment process
Coordinates the new patient referral process
Facilitates the procurement of outside medical records and materials
Organizes, files, and reviews outside medical records
Oversees protocol operations to ensure study compliance
Monitors data trends and alerts study team
Problem-solves protocol violations
Present at the study site
Communicates with the CROs supported by the study sponsor
Responsible for entering study data to the CROs database
Ensures regulatory compliance
Completes and submits required regulatory documents in a timely manner
Interfaces with NIH IRB to ensure timely filing of required reports
Works with study monitors, prepares for and participates in medical monitor reviews
Assists clinical staff with clinical implementation of the protocol
Work collaboratively in a multi-disciplinary environment
Appropriately delegate clinical and research tasks
Coordinates research specimen procurement and processing
Obtains consent for send in samples
Assists with specimen procurement procedures
Assists with coordination, handling, and shipment of study samples
Logs received samples in appropriate databases.
Processes outside material through the appropriate NIH departments
Manages and analyzes protocol data
Organizes study files
Maintains databases
Assists with the monitoring of and compliance with regulatory requirements
Assists with the creation and preparation of protocol training materials
Works collaboratively in a multidisciplinary environment to assist clinical staff with clinical implementation of the protocol
Trains staff (intramural and extramural)
Creates and provides protocol initiation and update trainings
This position is not credentialed for patient care
This position is located onsite in Bethesda, MD with the possibility of occasional telework
**THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL**
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state
Nurse Coord II, Protocol - In addition to the education requirement, a minimum of two (2) years of experience including managing clinical research protocols or directly related work
Nurse Coord III, Protocol - In addition to the education requirement, a minimum of five (5) years of experience including managing clinical research protocols or directly related work
Ability to wear personal protective equipment
Must be CPR certified or certifiable
Highly effective organizational and planning, problem-solving, and interpersonal skills
Highly effective computer skills
Working knowledge of biological principles and scientific methods
Working knowledge of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, clinical research concepts, ethics, processes, and clinical protocol implementation
Ability to perform word processing and spreadsheet applications independently with accuracy and speed
Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
Prior experience in clinical trials study coordination, especially investigational new drug studies
Knowledge and experience with clinical care or research trials in patient populations with immune deficiencies, cancer susceptibility or infectious diseases
Comfortable working with pediatric and adult participants
JOB HAZARDS
This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance
This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
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