Clinical Protocol Data Analyst II

Job ID: req4131

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 Clinical Trials Office (VCTO) pilot. The pilot 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 the clinical sites’ teams will help to offset clinical-trial specific activities, including subject screening, participant enrollment, and data entry.

A remote clinical research data analyst 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, entering research study participant data into an NCI application, and resolving queries.

Key Roles/Responsibilities

• Provides data entry and management support to an assigned caseload of research protocols; duties include, but are not limited to, the following:
• Data Collection, Entry, and Query Resolution
• Completes – timely and accurately - the collection and entry of research participant data and study-related information sourced from the Electronic Health Record (e.g., Epic, Cerner, etc.) into electronic clinical data capturing systems (e.g., eCRFs, Medidata Rave, REDCap) and clinical trial management systems (e.g., OnCore, Florence e-Reg, Velos eResearch, Complion, etc.), to ensure data integrity.
• Collaborates with local site staff and remote VCTO team members to report data and resolve queries to meet protocol requirements in an efficient and effective manner
• Files and maintains records in accordance with protocol and site-specific guidance
• Patient Identification, Screening, and Enrollment
• Assists in the identification and recruitment of participants for clinical protocols by:
• Facilitating the procurement of outside medical records and materials, and appropriately organizing and filing those materials
• Communicating with participants and referring providers about the screening and enrollment process
• Documenting screening and enrollment activities in appropriate enrollment databases (such as, NCI Oncology Patient Enrollment Network system, also known as OPEN)
• Protocol Planning and Monitoring
• Reviews study protocols and assists in the planning and implementation of the data management aspects of clinical research projects
• Works with Study Coordinators and/or other regulatory monitors on the review and analysis of data, to monitor participant safety and protocol endpoints
• Quality Assurance
• Evaluates clinical data for accuracy and completeness while ensuring the safety and confidentiality of research participants’ protected information, and any sensitive protocol information
• Reviews exported and/or manually entered data entries for accuracy and completeness
• Conducts tasks in compliance with clinical trial protocols, Good Clinical Practice (GCP), site-specific standard procedures, and applicable FDA regulations
• Collaboration
• Works collaboratively with VCTO team members, site staff, and data monitors to meet program and protocol requirements, deadlines, and deliverables
• Updates and/or maintains tracking tools to ensure protocol and program milestones are met in a timely manner
• Effectively tracks and accurately presents the status of assigned tasks at team meetings and other reporting periods
• Participates in virtual/online meetings with the clinical care teams at various clinical sites to review clinical research protocols, procedures, and reports
  

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) 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, 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
• Intermediate understanding of:
• Relational databases structures and reporting software
• 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
• Human anatomy and biology
• Cancer pathophysiology, cancer treatment modalities, and their side effects
• Technical proficiency using:
• Cloud–based clinical data management systems (e.g., Medidata Rave) and enrollment tracking systems (e.g., OPEN)
• Electronic health record systems (e.g., Epic, Cerner, etc.)
• Microsoft Office products (e.g., Excel, Word)
• Online/virtual platforms such as WebEx, Zoom, MS Teams
• Effective communication skills (written, verbal, and virtual)
• Ability to:
• Identify data trends and appropriately escalate findings
• Demonstrate strong initiative, accountability, and reliability
• Multidirectional leadership
• Manage customer relationships
• Troubleshoot basic IT problems
• Ability to obtain and maintain a security clearance
  

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

Prior Experience With

• Clinical oncology
• NCTN trials
• Performing user acceptance trainings
• OnCore, Velos eResearch, Complion
• Epic EMR
• Profressional certification in clinical research
• Basic proficiency in the performance of statistical calculations and analysis
  
  

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.

61,800.00 - 106,250.00

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.

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