Regulatory Documentation Analyst, Sr. (NCI) Job in Maryland (MD), Research and Development - cGMP Career, Full Time Jobs in Leidos Biomedical Research, Inc.
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Regulatory Documentation Analyst, Sr. (NCI) job in ROCKVILLE

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Leidos Biomedical Research, Inc. jobs
Maryland (MD), ROCKVILLE
Job Code:  661133
Employer:  Leidos Biomedical Research, Inc.
Category:  Research and Development - cGMP
Job Type:  Full Time

Location
Country:  United States
State:  Maryland (MD)
City:  ROCKVILLE
Map: 
09/11/2018

Description
Description:

PROGRAM DESCRIPTION

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 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, 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 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, 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)/Clinical Trials Reporting Office (CTRO) provides exceptional analysis capabilities in support of clinical cancer research and is primarily involved in the operations and execution of projects sponsored by NCI-CMRPD.

KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL

Senior Regulatory Documentation Analyst -


- Oversee NCI sponsored trials in CTRO and Clinical Trials.gov
- Contact designees for results reporting and follow-up on any dues
- Monitor NCI sponsored trials in Clinical Trials.gov and in CTRP reporting system
- Register results for all NCI sponsored trials in Protocol Registration and Results System (PRS)
- Run Protocol Registration and Results System (PRS) verification reports
- Generate comparison report to consolidate data for data accuracy and quality control
- Run daily reports to identify errors between CTRP reporting system and Clinical Trials.gov
- Liase between NCI and study sites designees
- Provide protocol data analyst support and data cleanup when needed
- Work closely with internal groups (CTEP, DCP, CCR, etc.) and external sites on data verification
- Identify and address data discrepancies to ensure data standardization and harmonization across clinical trials within CTRO
- This position is located in Rockville, Maryland

Qualifications:

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:


- Possession of an BA/BS degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education)
- Foreign degrees must be evaluated for U.S. equivalency
- In addition to educational requirements, a minimum of two (2) years of progressively responsible related experience as designated by the program requirements
- Ability to work in a busy setting, both independently and within a team
- Ability to troubleshoot and appropriately report unexpected problems that may arise
- Ability to effectively incorporate diverse feedback from the user community into a high quality document
- Willingness to perform tasks that may fall outside of the normal daily responsibilities
- Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:


- Working knowledge of SharePoint and other databases
- Proficiency with Microsoft applications
- Proficiency in regulatory output in clinical, research and pharmaceutical industries

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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.

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