Clinical Research Associate (NCI)

Location
20817, Bethesda
Posted
Jun 28, 2018
Ref
656308
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

 

PROGRAM DESCRIPTION

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 Monitoring Research Program (CMRP) provides clinical trials management and regulatory support to the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgical Oncology section of the Thoracic & Gastrointestinal Oncology Branch (TGIB).

KEY ROLES/RESPONSIBILITIES

  • Opens and closes studies
  • Provides clinical site management
  • Manages the relationship between CRO’s and field CRAs
  • Assists with design, planning and implementation of clinical trials
  • Manages and coordinates project activities associated with the monitoring functions of clinical studies
  • Ensures appropriate reporting of Adverse and Serious Adverse Events
  • Designs/produces patient Case Report Forms and manages the completion/collection of CRFs
  • Monitors clinical trials, tracks patient information, randomization and drug dispensing and accountability
  • Interacts with internal and external staff to facilitate project timelines
  • Oversees CRO activities, such as Investigator meetings, study initiation, ongoing monitoring, and close-out visits
  • Assists in preparation/production of documents for FDA submission, as well as annual protocol reports and manuscripts
  • Handles clinical research specimens (blood, urine, serum, etc.) to ensure samples are delivered to the appropriate facility for testing
  • 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:

  • Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials, health (Additional qualifying experience may be substituted for the required education).  Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirements, a minimum of five (5) years of progressively responsible experience in biomedical research, including a minimum of four (4) year directly related to overseeing multiple concurrent projects that comprise diverse functions of clinical research implementation processes and conduct
  • Must be proficient in all functions of clinical research implementation processes and conduct
  • Ability to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data and ensure documents are succinct
  • Knowledge of regulatory requirements and guidelines for facilitating clinical human subjects research (including Department of Health and Human Services [DHHS] regulations)
  • Familiarity with protocol and informed consent documents and approvals needed to initiate a study
  • Ability to prioritize multiple tasks and projects while establishing timelines, tracking milestones, and dealing with shifting priorities
  • Ability to submit quality products under tight deadlines
  • Proficiency in Microsoft Office
  • Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
  • Ability to communicate effectively, orally and in writing, with non-technical and technical staff
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Oncology experience
  • Knowledge of International Conference on Harmonization/Good Clinical Practices and DHHS regulations
  • Experience with the development of protocols including formatting and preparation, ICFs, and study monitoring plans
  • Knowledge of clinical trial design