Clinical Study Coordinator II

3 weeks ago

Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

Clinical Study Coordinator II - LOCAL

Job ID: req4057
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 coordination and support to the National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR).

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 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 and patient sampling procedures
Organizes and ships patient samples for further experimentation
Processes samples including PBMC extraction, CSF, oral rinses, and a variety of other sample types.
Authors clinical and laboratory SOPs and tests for quality assurance.
Completes lab projects and experiments from reagent preparation to data analysis.
Creates and manages workflow of sample collection from clinic to lab on multiple protocols.
Acts as a liaison between lab and clinic spaces.
Completes and tracks freezer inventory
Ensure compliance with safety protocols and ethical standards
Maintain a clean, organized, and efficient laboratory environment
Maintains accurate and comprehensive records of experiments, results, and procedures
Assist in preparation of figures, data, and writing for research publications
Manages quality assurance and data cleanliness from different sources
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
Travels occasionally for domestic and international conferences
Position is located in Bethesda, Maryland. Ad hoc telework available as determined by clinical and protocol needs

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 the education requirement, a minimum of two (2) years of progressively responsible experience in biomedical research
Including 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
Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

Five (5) years of progressively responsible experience in biomedical research
Infectious diseases experience
Experience with the development of CRFs, eCRFs, and study monitoring plans
Highly self-motivated
Flexibility to meet the needs of protocol and study team
Knowledge of database management
Experience with basic laboratory skills

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.

#readytowork

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