Clinical Trials Manager I/II - Bilingual Spanish
Job ID: req4100
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Rockville: Fishers Ln
Location: 5601 Fishers Ln, Rockville, MD 20852 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, COVID 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 comprehensive clinical support to the NIAID Division of Clinical Research (DCR) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics. This position will support the Collaborative Clinical Research Branch (CCRB) within the DCR. Responsibilities include but are not limited to:
KEY ROLES/RESPONSIBILITIES
- Oversees clinical research site management activities for DCR designated high-profile clinical research special projects in Indonesia, Mexico, Guinea, Liberia, US, and other countries as assigned.
- Assists with the planning and implementation of clinical trials/studies.
- Identifies and assesses clinical study sites and the necessary infrastructure to carry out clinical studies domestically and internationally, including clinical site assessment, clinical site preparation, clinical site training and clinical site logistical support
- Reviews sponsor protocol edits and Informed Consent Forms (ICF) edits, case report forms, study templates and manual of operations
- Development of Standard Operating Procedures (SOPs), and study specific manuals of procedures
- Oversight of monitoring activities
- Participates in managing and coordinating project activities for assigned clinical studies.
- Acts as a liaison between various Leidos Biomed staff, NIAID branches and divisions, and collaborator offices, interacting with both scientific and administrative officials.
- Coordinates and communicates efforts within the assigned activities to include organizing, planning, executing, reporting, and evaluating the assigned program objectives.
- Coordinate the development and management of complex Communication Guide documents.
- Collaborates with applicable Clinical Research Organizations (CROs) on site management activities.
- Coordinates meetings between various CROs and other stakeholders.
- Provides mentoring, leadership and supervision to other staff, both within DCR and in-country staff.
- Provide an overall quality assessment in preparation of CMRPD site audits and other monitoring visits, as needed.
- Reviews site audit and monitoring reports prior to and upon completion. Facilitates communication of findings to stakeholders and assists with the development/implementation of Corrective and Preventive Actions (CAPA).
- Oversees and provides input to mandatory and ancillary training activities.
- Travels up to 20%
THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL
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.
- Clinical Trials Manager I - In addition to educational requirements, a minimum of four (4) years of progressively responsible relevant experience in clinical research.
- including a minimum of two (2) years directly managing multiple concurrent clinical trials.
- Clinical Trials Manager II - In addition to educational requirements, a minimum of six (6) years of progressively responsible relevant experience in clinical research.
- including a minimum of four (4) years directly managing multiple concurrent clinical trials.
- International clinical trials experience.
- Clinical site monitoring/auditing experience, management of multiple concurrent clinical trials/projects and supervisory experience (progressively increasing responsibilities).
- Proficiency in all functions of clinical research implementation processes and conduct.
- In-depth knowledge of the clinical trial and drug development process.
- Ability to work in clinical research setting both independently and within a team to coordinate, negotiate, and facilitate study activities.
- Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP).
- Knowledge of clinical trial fieldwork concepts and practices.
- Strong customer focus with the ability to communicate effectively, both verbally and in writing.
- Strong problem solving, planning and organizational skills.
- Attention to details.
- Ability to prioritize multiple tasks and projects.
- Experience in setting up, training on, reviewing and maintaining trial regulatory binders/trial master files.
- Experience with IRB and health authority submission packages and continuing review packages.
- Fully bilingual English/Spanish.
- Ability to obtain and maintain a security clearance.
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Infectious disease and vaccine research experience.
- Knowledge of Quality Assurance/Quality Control processes.
- Knowledge of site selection activities and tracking site capabilities.
- Experience in preparing and managing site management budgets.
- Experience in data management and subcontracting.
- Knowledge and experience with document management.
- Clinical trial project management experience.
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, color, 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.