Clinical Research Associate II
Job ID: req2156
Employee Type: exempt full-time
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 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.
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), 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.
The Clinical Monitoring Research Program Directorate (CMRPD) provides regulatory, clinical trials management, , protocol development/navigation and program management support to the office of the Clinical Director, National Institute of Mental Health (NIMH).
- 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).
- Assists the clinical investigators and teams with ensuring adherence to all applicable guidelines, including GCPs and SOP
- Reviews protocol and Informed Consent Forms (ICFs) with development of these documents
- Coordinates monitoring activities of clinical studies 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
- 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 Bethesda, Maryland
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 Clinical Trials Management Systems
- 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
- Previous clinical trials monitoring or site management experience
- Ability to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
- Mental health experience
- Knowledge of Department of Health and Human Service (DHHS) regulations
- Experience with the development of Case report form design, manual of operations and study monitoring plans
- Knowledge of conducting federally funded studies
- ACRP Certified CRA or SOCRA Certified Clinical Research Professional
- Strong communication and presentation skills
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
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