Clinical Research Associate III - HYBRID

Job ID: req4000
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 specialized support for initiatives and special projects in support of the National Cancer Institute, Division of Cancer Prevention (DCP). CMRPD is responsible for providing clinical trial support services to NCI/DCP global clinical research studies. The CMRPD provides comprehensive clinical trials management and oversight support to the various clinical research initiatives of the NCI/DCP.

KEY ROLES/RESPONSIBILITIES

• Performs work independently, under the general guidance of the supervisor and is responsible for providing Quality Assurance (QA) and quality control oversight of clinical trials, to include coordinating Good Clinical Practice (GCP) monitoring of non-Investigational New Drug (IND) and IND protocols domestically and internationally; general QA for data; and the development and maintenance of databases tracking essential study documents and data for reports
• Provides expertise in the clinical research being conducted by NIH investigators, assists with the design, planning and implementation of clinical trials and project activities associated with the monitoring of both single and multi-center clinical studies, ensuring they are conducted in accordance with Standard Operating Procedures (SOPs), in-country regulations and GCPs
• Assists in developing and reviewing reports and report sections (including internal annual program reports), letters, templates, manuals of operation, monitoring plans, , protocol and consent forms, Corrective and Preventative Action Plans, internal SOPs (to ensure compliance with processes updates), team publications (posters, presentations, manuscripts, etc.), guidance documents (508 Compliance and FAQs), and other documents to enhance the quality of clinical trials
• Able to develop Case Report Forms (CRFs) in FrameMaker, editing CRFs, working through these with study teams and other NIH contractors to ensure proper setup
• Participates in coordinating center meetings, network investigator meetings, study initiation, routine monitoring and close-out visits, and Contract Research Organization (CRO) associated activities. Ensures appropriate reporting of Adverse Events and Serious Adverse Events, tracks patient information, verifies randomization, drug dispensing and accountability, and interacts with the internal and external personnel to facilitate project timelines
• Coordinates site initiation visits and other site monitoring visits for IND and non-IND studies and with CROs/independent monitors as needed
• Provides training and mentoring for team members with regard to monitoring processes for CTM, SOPs, GCP and daily activities. Serves as a liaison between coordinating clinical research sites, vendors, and other internal departments for multi-site studies
• Must be willing to travel globally
• Position is located in Frederick, Maryland, although remote work is also allowed

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/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 eight (8) years of progressively responsible experience in biomedical research
  • Including a minimum of four (4) years directly related to overseeing multiple concurrent protocols
• Must be proficient in all functions of clinical research implementation processes and conduct
• Possesses ability to work in clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data
• Detail-oriented and possesses strong organizational skills with the ability to prioritize multiple tasks and projects
• Demonstrates effective communication, both orally and in writing, with non-technical and technical staff
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Ability to multi-task and tackle difficult study related issues
• Specific knowledge of monitoring requirements, FDA regulations and GCPs, and utilization of databases
• Familiarity with regulatory requirements and guidelines for facilitating clinical human subjects research, as well as monitoring requirements to ensure integrity of data and site compliance
• Experience with monitoring studies domestic and international is a plus
• Working NCI experience is preferred
• Knowledge of 508 Compliance, Ministry of Health, International agencies, and Department of Health and Human Services regulations is a plus
• Experience with the development of Case Report Forms (CRFs); knowledge of Frame Maker is a plus
• Experience with the development of manual of operations, study monitoring plans and risk-based monitoring is a plus
• Experience with REDCap or Medidata Rave is a plus
• Knowledge of conducting federally funded studies
• Certified clinical research professional preferred
• Strong writing and proof-reading skills are a plus
• Maintaining a collaborative working relationship with the site Principal Investigators, study staff and CROs/outside monitors

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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