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Clinical Research Associate II (NCI)

Leidos


Location:
Frederick, Maryland
Date:
06/01/2017
2017-06-012017-07-01
Job Status:
Full Time
Categories:
  • Clinical Operations
Leidos
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Job Details

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 comprehensive, dedicated project management and clinical research to the National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC) for development of therapeutic and vaccines products, diagnostics, assays, and immune correlates leading to protection against flaviviruses, including Zika, advancing countermeasures protecting against flavivirus infection.

 

JOB DESCRIPTION/BASIC FUNCTION

The Clinical Research Associate II works as an in-house position.

Responsibilities Include:

Assists with the implementation of clinical trials, tracking studies and subject information, and coordinating project activities associated with the monitoring functions of clinical studies

Assists with the review of protocols, informed consents, and study related documents

Maintains and tracks regulatory files/essential Master Documentation Files (MDFs) while working closely with other team members to ensure these documents are properly managed and are accurate

Interacts and supports internal and external personnel to facilitate meeting project timelines and tasks in accordance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and all applicable regulatory guidelines

Supports Leidos CRAs and Project Managers with clinical site management

Assists with managing the relationship between Clinical Research Organizations (CROs) and field CRAs, as needed

Assists with investigator site activities in adherence to all applicable guidelines, including GCPs and SOPs

Ensures appropriate reporting of Adverse Events (AEs), Serious Adverse Events (SAEs) and unanticipated problems

Assists with the review and possible design and production of subject Case Report Forms (CRFs) and performing quality control on completed CRFs

Assists with clinical trials progress

Participates in and helps organize clinical trial activities with CROs, such as investigator meetings, study initiation, ongoing monitoring and close-out visit activities when applicable

Assists in preparation and production of documents for Food and Drug Administration (FDA) submission, as well as annual IND protocol reports

May assist in conducting site visits and initiating draft reports and letters in a timely manner to ensure compliance with SOPs

May require travel 5-10%

Requirements

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

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.

A minimum of one (1) year on-site clinical monitoring or site management experience

Ability to work in a clinical research setting both independently and within a team

Ability to prioritize multiple tasks/projects through effective organization/planning skills

General knowledge of clinical trial fieldwork concepts and practices, FDA regulations and GCPs

Knowledge of database management

Willing to travel approximately 5 -10% domestic/international, if needed

Must be able to obtain and maintain a Security Clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

Familiarity with FDA regulatory requirements and guidelines for clinical research, as well as monitoring requirements

Infectious diseases experience

Knowledge of Department of Health and Human Services regulations

Experience with the development of CRFs

Fluent in Latin American Spanish and/or Brazilian Portuguese

 

Leidos Overview:

Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.Other Locations: