Clinical Trials Data Entry Specialist II
Posted November 11, 2025
Job ID: req3374
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: 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 strategic, operational, and program/project management support to domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and various other institutes within the National Institutes of Health (NIH). CMRPD's services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD facilitates and supports clinical trials that investigate the prevention, diagnosis, and therapeutic treatment of cancer, influenza, HIV, and other diseases and disorders.
CMRPD is providing support to NCI's Division of Cancer Treatment and Diagnosis (DCTD) Virtual Research Support (VRS) program. This new program aims to determine if enrollment to NCI clinical trials, particularly for minority and underserved populations, can be improved by establishing a team of virtual research support staff to provide remote, centralized support to U.S. research sites sponsored by NCI, including those participating in the NCI Community Oncology Research Program (NCORP). The remote support provided to the clinical sites' teams will help to offset clinical-trial specific activities, including subject screening, participant enrollment, and data entry.
A remote Clinical Trials Data Entry Specialist is required to supplement and compliment the clinical sites' teams to offset specific clinical trial-specific activities, such as supporting data abstraction from local electronic health record systems and entering research study participant data into an NCI application.
KEY ROLES/RESPONSIBILITIES
- Receives, reviews, and processes clinical trial participant data and records and organizes clinical data forms from therapeutic groups and outside investigators
- Provides accurate, timely, and consistent clinical data to the medical department and other groups
- Evaluates clinical data for accuracy and completeness while ensuring the safety and confidentiality of clinical trial participant data
- Enters study participant data into the NCI Oncology Patient Enrollment Network (OPEN) application
- Reviews Electronic Health Record (EHR) records and supports clinical protocol data abstraction from EHRs into the NCI Clinical Data Management System (Medidata Rave)
- Performs quality control checks to provide accurate, timely, and consistent clinical data abstractions and data entry
- Performs necessary outreach to the cancer center community to obtain missing protocol/patient information
- Conducts tasks in compliance with clinical trial protocols, Good Clinical Practice (GCP), standard procedures, and applicable FDA regulations
- Works closely with clinical sites, virtual team members, and other collaborators on data verification and database activities for paper and electronic data capture (EDC) studies
- Updates and/or maintains tracking tools to ensure project milestones are met
- Reviews exported and/or manually entered data entries for completeness
- Records, tracks, and ensures resolution of data queries
- Reviews data entry guidelines for potential errors and/or logic discrepancies and escalate findings
- Conducts data validation exercises to ensure completeness, accuracy and integrity of data entered
- Participates in virtual/online meetings with the clinical care teams at various clinical sites to review clinical research protocols, procedures, and reports
- Files and maintains records in accordance with protocol and site-specific guidance
- This position is 100% remote
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a (CHEA) bachelor's degree from an accredited college/university, or qualifying experience in lieu of required education
- In addition to educational requirements, a minimum of two (2) years of progressively responsible, relevant data coordination experience in clinical research, including work with EHRs and other electronic data capture systems, as well as a basic understanding of clinical trials/protocols
- Experience working with clinical research data
- Experience using cloud-based clinical data management systems such as Medidata Rave
- Technical proficiency using electronic data capture (EDC) systems, Microsoft Office products (e.g., Excel, Word), and online/virtual platforms such as WebEx, Zoom, MS Teams
- Knowledge of drug and disease terminology
- Understanding of the Department of Health and Human Services (DHHS) regulations for the protection of human research participants
- Knowledge of relational databases structures and reporting software
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Ability to identify data trends
- Familiarity with clinical trials and knowledge of Department of Health and Human Service (DHHS) regulations
- Basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) and general understanding of institutional review board (IRB) processes
- Experience performing user acceptance trainings
- Effective communication skills (written, verbal, and virtual)
- Familiarity with different electronic health record systems
- Familiarity with NCI's Oncology Patient Enrollment Network (OPEN) application
- Familiarity with oncology protocols
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
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