The Frederick National Laboratory, operated by Leidos Biomedical Research, Inc., is seeking a Clinical Protocol Data Analyst II to support the NCI's Division of Cancer Treatment and Diagnosis (DCTD) Virtual Clinical Trials Office (VCTO) pilot. This pilot aims to improve enrollment in NCI clinical trials, especially for minority and underserved populations, by providing remote, centralized support to U.S. research sites. The analyst will help offset clinical trial-specific activities such as subject screening, participant enrollment, and data entry.
Requirements
- A minimum of two (2) years of progressively responsible, relevant data coordination experience in clinical research, including work with Electronic Health Records and other electronic data capture systems, as well as a basic understanding of clinical trials/protocols.
- Prior experience with NCI's National Clinical Trials Network (NCTN) trials.
- Intermediate understanding of: Relational databases structures and reporting software
- Intermediate understanding of: Department of Health and Human Services (DHHS) regulations for the protection of human research participants and other applicable regulatory guidelines (FDA/CFR, ICH/GCP)
- Basic knowledge of: Institutional review board (IRB) processes
- Technical proficiency using: Cloud–based clinical data management systems (e.g., Medidata Rave) and enrollment tracking systems (e.g., OPEN)
- Technical proficiency using: Electronic health record systems (e.g., Epic, Cerner, etc.)
Responsibilities
- Provides data entry and management support to an assigned caseload of clinical research protocols; duties include, but are not limited to, the following:
- Data Collection, Entry, and Query Resolution
- Patient Identification, Screening, and Enrollment
- Protocol Planning and Monitoring
- Quality Assurance
- Collaboration
Other
- Possession of Bachelor’s degree 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.
- Effective communication skills (written, verbal, and virtual)
- Ability to: Identify data trends and appropriately escalate findings
- Ability to: Demonstrate strong initiative, accountability, and reliability
- Ability to obtain and maintain a security clearance
