Clinical Research Associate (NCI)

Location
Frederick, Maryland
Posted
Feb 26, 2018
Ref
648723
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.

KEY ROLES/RESPONSIBILITIES

The Clinical Monitoring Research Program (CMRP)/Regulatory Compliance and Human Subjects Protection Program (RCHSPP) provides regulatory, clinical trials management, pharmacovigilance, protocol development/navigation and program management support to the National Institute of Allergy and Infectious Diseases’ (NIAID's) Intramural Clinical Research Community.

The Clinical Research Associate (CRA) II:

  • Provides clinical trials monitoring for Phase I-III single site to large networks of clinical sites participating in Investigational New Drug (IND) and non-IND protocols
  • Ensures sites are following U.S. Food and Drug Administration (FDA) regulations for INDs and Investigational Device Exemptions (IDEs) studies, International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) guidelines, and other applicable regulations
  • Verifies source documentation for the appropriate recording and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Critically evaluates clinical trials data for accuracy and completeness while ensuring the safety and confidentiality of participants according to the study monitoring plan
  • Provides assistance with monitoring of pharmacy records, including receipt, storage, labeling and final packaging, inventory, distribution and the processing and disposal of returned investigational agents according to the study monitoring plan and Standard Operation Procedures (SOPs)
  • Maintains relationships with Investigators, study site staff, network entities, Clinical Research Organizations (CROs) and field CRAs
  • Reviews protocol and Informed Consent Forms (ICFs) and provides suggestions to the clinical investigator
  • Coordinates monitoring activities of clinical studies for domestic and international sites (as assigned) including:  conducting site study initiation, on site monitoring and close-out visits, completing reports/letters in a timely manner, ensuring the conduct of the trial is in compliance with the approved protocol/amendment(s), ICH/GCP, SOPs, NIAID Institutional Review Board (IRB), other IRBs 2and NIH policies, and applicable regulatory requirements
  • Assists other CRAs and Project Managers in the development of team processes and study-related documents
  • Assists with ensuring required approvals are in place to initiate intramural research
  • Assists review of documents for submission to the FDA or other regulatory bodies
  • Maintains Essential Documentation file contents and ensures all required essential study documents are current, complete, and accurate
  • Ensures Clinical Trial Database systems are updated in a timely manner and are accurate.
  • Provides assistance to the clinical investigators and teams to reinforce and enhance a GCP culture
  • Travels 30-40% locally, domestically and possibly internationally

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/university in a field related to biomedical research, clinical trials and/or health (Additional qualifying experience may be substituted for the required education); Foreign degrees must be evaluated for U.S. equivalency
  • Must be able to obtain and maintain a security clearance
  • In addition to education requirements, a minimum of two (2) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to overseeing multiple concurrent trials/sites and on-site clinical monitoring or clinical site management experience
  • Ability to work in a clinical research setting, both independently and within a team
  • Ability to prioritize multiple tasks/projects and accomplish goals and meet expected timelines through effective organizational and planning skills
  • Ability to communicate effectively, verbally and in writing, with non-technical and technical staff
  • Knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and ICH/GCP
  • Proficiency with Microsoft Office products including Microsoft Word, Outlook, and Excel
  • Experience with electronic or remote data capture monitoring as well as paper based monitoring
  • Ability to travel approximately 30-40 % locally, domestically and possibly internationally
  • Previous clinical on-site monitoring or site management experience

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • ACRP Certified CRA or SOCRA Certified Clinical Research Professional
  • Infectious diseases experience
  • Knowledge of an electronic Clinical Trials Management Systems
  • Knowledge of Department of Health and Human Service (DHHS) regulations
  • Experience developing Case Report Forms (CRFs), eCRFs, manual of operations and study monitoring plans
  • Experience conducting federally funded studies
  • Knowledge of international regulatory requirements
  • Ability to read and/or speak French or Spanish