Clinical Study Coordinator II - NIH / NIAID

Clinical Study Coordinator II - NIH / NIAID

Job ID: req3730
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: NIH
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.

PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc. (operator of the Frederick National Laboratory for Cancer Research), the Clinical Research Directorate (CRD) provides clinical supervision of programs at the clinical end of the research spectrum. The quality assurance programs provide the required autonomy and transparency of Good Manufacturing Practice quality assurance operations. CRD also provides operational support for clinical research and supports clinical trials management, regulation, pharmacovigilance, and protocol development/protocol navigations. These support services include dedicated clinical research professionals who provide patient care to clinical trial participants at the National Institutes of Health (NIH) Clinical Center, and other research services that support the domestic and international clinical research initiatives of the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and several other institutes within NIH. CRD’s support services are strategically aligned with its mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, protecting human subjects, and helping to advance scientific clinical research. CRD facilitates the conduct of NIH-sponsored clinical trials that investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, parasitic infections, heart, lung and blood disorders, and rare and neglected diseases. CRD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CRD’s mission has contributed to improving the overall standards of public health on a global scale. 

The Clinical Research Directorate (CRD) provides clinical research nursing coordination and support to the National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR). This position will provide support to the Laboratory of Clinical Immunology and Microbiology (LCIM), Translational Mycology section. 

KEY ROLES/RESPONSIBILITIES

• Assists with the recruitment of research participants and the collection, management, and analysis of data
• Assists with protocol development and contributes to the preparation of regulatory submissions to the Institutional Review Board (IRB)
• Monitors intramural research protocols and ensures the clinical trials are conducted in accordance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and all applicable regulatory guidelines
• Assists with opening, monitoring, and closing studies, clinical site management, and managing the relationship with Clinical Research Organizations (CROs) and field CRAs
• Assists with the design, planning, and implementation of clinical trials, as well as the management and coordination of project activities associated with the monitoring functions of clinical studies
• Assists with investigator site management activities in adherence to all applicable guidelines, including GCPs and SOPs
• Ensures appropriate reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Assists with the design, production, collection, and completion of Case Report Forms (CRFs) and Electronic Case Report Forms (eCRFs)
• Reviews clinical trial data for quality and completeness
• Tracks patient enrollment, randomization, and drug dispensing
• Ensures the safety and confidentiality of study subjects
• Interacts with internal and external personnel to facilitate project timelines
• Assists in preparing documents to be submitted to the Food and Drug Administration (FDA), as well as annual protocol reports, manuscripts, and abstracts for publication
• Attends weekly laboratory meetings, clinic conferences, and other seminars/meetings
• Conducts site visits and completes reports in a timely manner
• Travels occasionally for domestic and international conferences
• Position is located in Bethesda, Maryland with ad hoc telework 

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 (CHEA) in a field related to biomedical research, clinical trials and/or health. Additional qualifying experience may be substituted for the required education
• Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, 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 trials/sites and on-site clinical monitoring or clinical sites management experience
• Ability to work in a clinical research setting both independently and within a team
• Ability to prioritize multiple tasks/projects through effective organization/planning skills
• General knowledge of clinical trial fieldwork concepts and practices, FDA regulations and GCPs
• Knowledge of database management
• Must be detail oriented with highly effective communication and computer skills
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Prior experience in infectious diseases
• Knowledge of Department of Health and Human Service (DHHS) regulations
• Experience with the development of CRFs, eCRFs, and study monitoring plans
• Knowledge of conducting federally funded studies or multi-center studies
• Experience or willingness to train in safe sample handling and processing practices 

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

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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