Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) 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 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, CMRPD’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. CMRPD’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, CMRPD 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. CMRPD’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 Monitoring Research Program Directorate (CMRPD) provides comprehensive, dedicated clinical research and study coordination in support of the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Office of the Clinical Director (OCD).
• Primarily responsible for the coordination of patient activities required for patient participation in study protocols, in order to provide study team with ability to adhere to protocols schedule of events and study calendar
• Coordinates and assists with timely scheduling of tests and visits (using instructions from research nurses), obtaining all results and records, and arrangement of patient travel and lodging for all patients being screened and enrolled into ongoing trials
• Tracks all relevant information using software tools (i.e., Excel, OneNote, Access) that allow for timely and accurate monitoring of information by entire study team
• Performs tracking on new patient calls using Excel
• Schedules tests needed for study evaluation, as well as protocol-specific tests, including MRI, CT, ultrasound, EKG, x-rays, blood tests, etc.
• Notifies patients and functions as primary liaison with all involved Clinical Center units of date and time tests are scheduled for patients.
• Notifies clinical staff of patients who call to cancel and/or reschedule appointments
• Identifies solutions for new or unique day-to-day problems by adapting processes and procedures with meet the needs of the team regarding coordination of patient care
• Designs appropriate mechanisms for follow-up test scheduling and return visits
• Responsible for ensuring that copies of patient films (CT Scans, PET, Nuclear Medicine Scans) and labs have been sent to the patient’s local MD, referring MD, or other treatment facility, as needed or requested
• Handles certain screening telephone calls, using discretion ascertaining the purpose of the call and demonstrating thorough knowledge of the clinical program by providing information or making appropriate referrals
• Responsible for patient information into clinical/admissions systems. Responsible for identifying alternate procedures as needed for unique scenarios. Receives, labels, and uploads patient medical record notes with patient Medical Record into CRIS
• Prepares all necessary travel and admission documents for the patients that are requested by Clinical Center units and the study team
• Prepares phlebotomy requests (EARs) and ATVs for patients visiting the clinic and ensures receipt by Admissions and other involved departments
• Calls external Pathology Departments to obtain slides and tissue blocks in advance of patient’s visit
• Prepares new patient workbooks (source documents that can’t be uploaded into CRIS) for use by clinic staff and maintains clinic charts. Files that same information into regulatory binders as appropriate
• Prepares research folders for new patients as requested by team
• Develops and utilizes, systems to communicate with physicians who refer selected patients to the Branch, who don’t qualify for the current trial, but might be eligible for future trials
• Receives and delivers tissue and biological samples, internal and external films, disks, to relevant departments
• Completes Tissue Transfer Forms and deliver to the appropriate individual or department
• Organize and track pathology slides; sends pathology slides back to originating hospital; keeps pathology mailing list up to date
• Copies consent forms and distributes to Research Nurse and all involved units, mails to patient
• Enters patient travel authorizations (ATV’s) and EARs daily
• Ensures patient is educated regarding pre-operative studies and procedures
• Responsible for exLOC procedures: including coordination of off-site registrations, obtaining medical records numbers, and obtaining results
• Submits inpatient unit and day hospital pre-admit forms prior to patients’ arrival
• This position is located in Bethesda, Maryland.
Qualifications and Job Details
Required and Preferred Skills
- Possession of a high school diploma or equivalent
- Foreign degrees must be evaluated for U.S. equivalency
- A minimum of five (5) years of progressively responsible administrative experience
- Experience and competency with the following Microsoft Office products: Excel, Outlook, Word, PowerPoint
- Experience scheduling patient appointments and maintaining patient records
- Understanding of clinical operations in order to provide adequate patient care arrangements
- Strong customer service focus
- Strong organizational skills with the ability to successfully manage competing priorities
- Resourcefulness in problem solving
- Ability to perform with reasonable level of independence and accountability
- Knowledge of purchasing requests, accounting policies and facility planning
- Must be able to obtain and maintain a security clearance
- Knowledge of medical/scientific objectives and terminology
- General familiarity with requirements of clinical protocols
- Knowledge of special ambulatory care regulations
About the NCI Center for Cancer Research
The Center for Cancer Research (CCR) is home to nearly 250 basic and clinical research groups located on two campuses just outside of Washington, D.C. CCR is part of the National Cancer Institute (NCI) and makes up the largest component of the research effort at the National Institutes of Health (NIH). Centrally supported by long-term funding and a culture of complete intellectual freedom, CCR scientists are able to pursue the most important and challenging problems in cancer research. We collaborate with academic and commercial partners and advocacy groups across the world in efforts to prevent, diagnose and treat cancer and HIV/AIDS. The CCR research portfolio covers the full spectrum of biological and biomedical research. Our work ranges from basic to translational and clinical, and our clinical trials are conducted in the NIH Clinical Center, the world’s largest hospital dedicated to clinical research that offers a robust infrastructure to support CCR’s patients on an estimated 250 open studies. The success of CCR is grounded in an exceptionally strong discovery research program that provides the foundation for the seamless translation of insights from bench to bedside. Read more about CCR, the benefits of working at CCR and hear from our staff on their CCR experiences.
Bethesda is one of the most highly educated communities in the United States and has a nationally renowned school system. The city is a thriving suburban center close to Washington, D.C., and home to many restaurants, retailers and a flourishing arts and entertainment district.
Additional Information: “Please reference job id req2609 for all inquiries.”
Hiring for this position will be through Leidos Biomedical Research Inc., a wholly owned subsidiary of Leidos, Inc. Leidos Biomedical is the operations and technical support contractor for the Frederick National Laboratory for Cancer Research, a federal national laboratory.