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Medical Monitor I

Job ID: req1266
Employee Type: exempt full-time
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

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 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 (NIH) 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 monitoring, 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) provides specialized support for initiatives and special projects in support of the National Institute of Allergy and Infectious Diseases (NIAID) Division of Clinical Research (DCR).  CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging and re-emerging infectious disease studies globally.  The CMRPD, Clinical Safety Office (CSO) provides comprehensive clinical safety management and oversight support to the various clinical research initiatives of the NIAID, DCR.

KEY ROLES/RESPONSIBILITIES

  • Provides broadly based regulatory, ethical, GCP and medical evaluation of key documents including protocols, informed consent documents, and investigator brochures for proposed and ongoing clinical trials, as well as related administrative activities to help ensure efficient, effective, and compliant study conduct and safety oversight of drug, vaccine, biologic, diagnostic, and device research that includes FDA investigational drug (IND) and device (IDE) safety data monitoring, review, reporting, and related RCHSPP activities
  • Works closely with study teams, government customer, and the RCHSPP regulatory and monitoring groups to facilitate timely, complete, accurate, and informative adverse event reporting to other regulatory and oversight entities such as FDA and IRBs
  • Performs investigational product safety reviews and participates in the preparation of technical and regulatory documents
  • Acts as the Sponsor Medical Monitor of record and provides medical safety monitoring for ongoing clinical trials conducted under the OCRPRO sponsorship
  • Reviews and interprets clinical data on a real-time basis, including report review, teleconferences, and other activities in collaboration with the Principal Investigator or Data Management Center, if applicable, and makes recommendations and determinations as appropriate and required to help ensure the protection of study participants
  • Reviews serious adverse event reports from clinical sites to determine if an Investigational New Drug (IND) Safety Report or an Unanticipated Adverse Device Effect Safety Report is needed
  • In conjunction with responsible investigator, oversees and approves the preparation of safety information for reporting to regulatory bodies
  • Ensures, in conjunction with Regulatory Affairs, compliance with regulatory reporting requirements for safety reporting in domestic and international clinical trials
  • Assists with preparation of INDs and IND Annual Reports as they relate to clinical safety information
  • Provides expert consultation, as appropriate, to Investigators and study teams on protocol procedures related to safety and compliance with regulations and guidance, including, but not limited to, population selection criteria and screening, safety testing, pausing and halting, blinding, DSMB and other safety oversight, communication of information and risks in plain language for informed consent, toxicity table selection, and rules governing protocol evaluation and reporting of serious adverse events, unanticipated problems, lab abnormalities, subject withdrawals, in accordance with regulatory requirements
  • Serves on assigned project/product teams or sub teams to provide guidance regarding safety-related issues
  • Provides representation and coverage for the Director of Clinical Safety and other Medical Monitor(s) as necessary to ensure smooth function and avoid gaps in oversight, and provides consultation, expertise and clinical leadership as appropriate for clinical and non-clinical members
  • This position is located in Frederick, Maryland 

BASIC QUALIFICATIONS

  • Possession of a Doctoral degree (e.g. M.D., Pharm.D.) from an accredited college or university in a field related to biomedical research or life science
  • Foreign degrees must be evaluated for U.S. equivalency
  • Knowledge of or experience with drug safety within the pharmaceutical industry, academic facility, or clinical research involving allergy, infectious diseases, or other relevant field
  • Knowledge of pharmacovigilance, clinical safety regulations and guidelines, and clinical research trials methodology, design, implementation and analysis
  • Knowledge of FDA regulations, ICH/GCP guidelines, the NIH's Office of Human Research Protections regulations, and clinical trials research and management
  • Ability to communicate effectively with the Sponsor or designee, clinical study staff and RCHSPP staff
  • Ability to render decisions and policy interpretations, and provide guidance and leadership in the performance of complex planning, coordination and evaluation of duties for a clinical trial project
  • Ability to independently identify problems and effectively offer solutions to problems
  • Ability to comprehend, integrate and interpret scientific and medical data from a variety of sources
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

  • Three (3) years of experience relevant to drug safety in the pharmaceutical industry or related industry
  • Post graduate clinical research training
  • Ability to present scientific information to both technical and non-technical audiences
  • Experience in computer software packages including Microsoft applications

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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