Clinical Research Associate II in Frederick, MD

Description

Clinical Research Associate II

Job ID: req2125
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.

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

 Position Overview:

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH.  CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD'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 to 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
• Provides 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 field CRAs
• Assists the clinical investigators and teams to reinforce and enhance a GCP culture
• Reviews protocol and Informed Consent Forms (ICFs) and assists the clinical investigators
• Coordinates monitoring activities of clinical studies for domestic and international sites including: conducting 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 Project 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 located in Frederick, Maryland

BASIC QUALIFICATIONS

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

• Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials and/or health or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, 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 clinical trials
• 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®, 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 30-40% (including to NIH)
• Previous clinical monitoring or 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) regulations is a plus
• Experience with the development of manual of operations and study monitoring plans
• Knowledge of conducting federally funded studies
• Ability to read French or Spanish
• ACRP Certified CRA or SOCRA Certified Clinical Research Professional
• Knowledge of international regulatory requirements

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

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