Protocol Data Analyst Lead/Manager (NCI)

Location
Rockville, Maryland
Posted
Jan 31, 2018
Ref
647497
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

  • Manage a team of Protocol Data Abstractors
  • Ensure an existing 10-business day Service Level Agreement (SLA) for new trial and amendment submissions to the Clinical Trials Reporting Program (CTRP) is met
  • Work with staff on tickets submitted to the EnterpriseWizard (EW) issue tracking system and ensuring timely response and accuracy in completion of issues/questions submitted
  • Train staff on daily tasks and monitoring performance on schedule with complete accuracy
  • Ensure consistent abstraction, curation and coding of clinical trial related data
  • Suggest system and process improvements while working closely with the CTRP Engineering team on system improvements/enhancements
  • Work closely with the Director of Clinical Trials Operations to provide consistent data quality and to immediately address issues as they arise
  • Perform quality control reviews on the team’s trial abstractions
  • Update and maintain Standard Operating Procedures (SOPs)
  • Supervise staff and assist with new employee training

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. (Additional qualifying experience may be substituted for the required education); Foreign Degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, a minimum of four (4) years of progressively responsible job related experience including one (1) year of experience in a leadership/management capacity (May be pharmaceutical, clinical, clinical research, etc.)
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Familiarity with the area of clinical trials, both interventional and non-interventional, in the field of Oncology

Expected Competencies:

  • Exceptional written and oral communication skills
  • Ability to work in a fast paced environment
  • Ability to work in a team and independently
  • Ability to communicate effectively with high-level personnel
  • Ability to attend meetings as a program liaison
  • Willingness to perform tasks that may fall outside of the normal daily responsibilities
  • Proficiency with Microsoft software applications