Clinical Research Associate II - HYBRID

Job ID: req3997
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

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 regulatory, clinical trials management, pharmacovigilance, protocol development/navigation and program management support to the Regulatory Compliance and Human Subjects Protection Program (RCHSPP), Office of Clinical Research Policy and Regulatory Operations (OCRPRO) of the National Institute of Allergy and Infectious Diseases' (NIAID) Division of Clinical Research (DCR).

KEY ROLES/RESPONSIBILITIES

• Provides clinical trials monitoring for Phase I-III single site and 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, Investigational Device Exemptions (IDEs), International Conference on Harmonisation (ICH)/ Good Clinical Practice (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 data for accuracy and completeness while ensuring the safety and confidentiality of participants according to the study monitoring plans
• Conducts monitoring of pharmacy records, including receipt, storage, labeling and final packaging, inventory, distribution, accountability and the processing and disposal of returned investigational agents according to the study monitoring plans, protocol and Standard Operating Procedures (SOPs), chain of accountability.
• Maintains relationships with Investigators, study site staff, network entities, Clinical Research Organizations (CROs) and other CRAs
• Provides assistance to the clinical investigators and teams to reinforce and enhance a GCP culture
• Reviews protocol and Informed Consent Forms (ICFs)
• Coordinates monitoring activities of clinical studies for domestic and international sites including conducting on site or remote site initiation, monitoring and close-out visits, completing reports in a timely manner, ensuring the conduct of the trial is in compliance with the approved protocol, SOPs, International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), Institutional Review Board (IRB)s and NIH policies, and applicable regulatory requirements
• Assists other CRAs and Clinical Trials Managers in the development of team processes and study-related documents
• Assists with ensuring required approvals are in place to initiate intramural research
• Assists in the preparation and production of documents for FDA submissions, as well as IND annual protocol reports and manuscripts
• Reviews or helps create internal and/or external SOPs, guidelines and tools
• Travels to domestic and possible international clinical sites as assigned
• Maintains Essential Documentation File contents and reconciliation of the documentation including ensuring all required essential study documents are current, complete, and accurate
• Ensures Clinical Trial Database Systems are updated to be current, accurate and complete in a timely manner
• This position is in- Frederick, Maryland with the ability to work remotely

BASIC QUALIFICATIONS

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

• Possession of Bachelor's degree in a field related to biomedical research, clinical trials and/or health from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to education requirements, a minimum of five (5) years of progressively responsible experience in biomedical research
  • Including a minimum of one (1) year directly related to overseeing multiple concurrent clinical trials including on-site clinical monitoring
• Ability to work in a clinical research setting, both independently and within a team
• Ability to prioritize multiple tasks/projects and accomplish goals in expected timelines
• Ability to communicate effectively, verbally and in writing, with non-technical and technical staff
• General knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and GCPs
• Knowledge of TrackWise® or other Clinical Trials Management Systems (or other similar systems (OpenClinica, ClinPlus, etc.)
• Extensive experience using various software applications such as MS Excel, Word, PowerPoint, and Adobe Acrobat; relational databases structures and reporting software
• Ability to manage projects involving large volumes of data
• Must be willing to travel approximately 20-30 % (including to NIH)
• Previous clinical monitoring and site management experience
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Infectious diseases experience
• Knowledge of Department of Health and Human Service (DHHS) regulation and conducting federally funded studies
• Experience with the development of manual of operations and study monitoring plans
• Ability to read French or Spanish
• ACRP Certified CRA or SOCRA Certified Clinical Research Professional
• Knowledge of international regulatory requirements

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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