Clinical Research Associate II - NIMH

Job ID: req4753

Employee Type: exempt full-time

Division: Clinical Monitoring Research Program

Facility: Telework: US

Location: USA

The Frederick National Laboratory is 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 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).

Key Roles/Responsibilities

• Conducts risk-based clinical trials monitoring for FDA regulated Phase I-III single site and multi-site studies, including Investigational New Drug (IND), Investigational Device Exemption (IDE) and non-IND/IDE protocols
• Plans, coordinates, and conducts independently Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), Remote Monitoring Visits (RMVs), and Close-Out Visits (COVs)
• Ensures compliance with FDA regulations, ICH Good Clinical Practice (GCP) guidelines, DHHS regulations, NIH policies and protocol-specific requirements
• Performs source document review and source data verification activities to assess participant eligibility, informed consent, investigational product accountability, safety reporting, protocol compliance and data integrity.
• Verifies the appropriate identification, assessment, documentation, follow-up and ion reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), Unanticipated Problems (Ups), protocol deviations, and other reportable events
• Reviews protocol requirements and confirms study activities are conducted in accordance with approved protocols, informed consent documents, monitoring plans, and regulatory requirements
• Critically evaluates clinical, regulatory and operational study data for completeness, accuracy, consistency and compliance
• Monitors investigational product accountability activities, including receipt, storage, dispensing, preparation, administration, inventory reconciliation, destruction, and chain-of-custody documentation
• Reviews pharmacy, laboratory, imaging, and ancillary study documentation to ensure protocol compliance and proper documentation practices
• Prepares comprehensive monitoring reports, follow-up letters, site activation documents, monitoring correspondence, and study tracking tools
• Identifies, communicates, and follows through on monitoring findings, compliance concerns, protocol deviations, and corrective/preventive actions through resolution
• Supports protocol activation activities through review of essential documents, delegation logs, training records, investigator qualifications, regulatory approvals, and site readiness documentation
• Assists investigators and study teams with interpretation of regulatory requirements, protocol compliance expectations, monitoring findings, and documentation standards
• Provides guidance and training to investigators, coordinators, protocol navigators, research nurses, and study staff regarding monitoring expectations and clinical research compliance requirements
• Participates in inspection readiness activities and provides support during sponsor audits, FDA inspections, and regulatory reviews
• Maintains effective working relationships with investigators, protocol navigators, project managers, contract research organizations (CROs), NIH staff, and external stakeholders
• Maintains and reconciles Essential Documentation File contents and ensures required study records remain current, complete, accurate, and inspection-ready
• Reviews and updates clinical trial management systems and electronic clinical research databases to ensure information remains current, accurate, and complete
• Participates in the development and revision of standard operating procedures (SOPs), monitoring tools, templates, guidance documents, and quality improvement initiatives
• Assists with onboarding, training, and mentoring of junior staff as appropriate
• Travels to domestic and occasional international clinical research sites as assigned
• This position is remote

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, public health, nursing, life sciences, or a related discipline; 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 or clinical research, including at least one (1) year of experience supporting multiple concurrent clinical trials
• Clinical trial monitoring experience
• Ability to work independently and collaboratively in a fast-paced clinical research environment
• Strong organizational skills with the ability to prioritize multiple projects and meet deadlines
• Strong verbal and written communication skills with the ability to interact effectively with both technical and non-technical stakeholders
• Demonstrated knowledge of clinical research regulations, including U.S. Food and Drug Administration (FDA) regulations (21 CFR Parts 11, 50, 54, 56, 312, and/or 812), International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines (E6), Department of Health and Human Services (DHHS) human subjects protection regulations (45 CFR 46), and applicable NIH policies and procedures governing clinical research. Experience interpreting and applying regulatory requirements to support protocol compliance, participant safety, data integrity, adverse event reporting, investigational product accountability, monitoring activities, and inspection readiness
• Knowledge of clinical trial monitoring principles, source documentation review, informed consent review, eligibility assessment, adverse event reporting, protocol compliance activities, and investigational product accountability
• Knowledge of Clinical Trials Management Systems (CTMS) and electronic clinical research systems
• Experience using Microsoft Office Suite, including Excel, Word, PowerPoint, Outlook, and Adobe Acrobat
• Experience working with electronic data capture systems, clinical trial databases, electronic medical record systems, and regulatory document repositories
• Ability to manage projects involving large data sets and multiple stakeholders
• Previous quality assurance, compliance or site management experience
• Ability to obtain and maintain security clearance

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

• Mental health experience
• Knowledge of Department of Health and Human Service (DHHS) regulations is a plus
• Experience with the development of Case report form design, manual of operations and study risks based monitoring plans
• Knowledge of conducting federally funded studies
• Familiarity with NIH
• ACRP Certified CRA or SOCRA Certified Clinical Research Professional
• Located in the D.C. Metropolitan area

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, 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.

Pay And Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

78,600.00 - 112,800.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions