Clinical Informatics Specialist

Pharmaron • Baltimore, MD

1d • $24 - $30 • Hybrid

About The Position

Responsible for providing comprehensive protocol details and identifying key data collection points necessary for the Clinical Applications Team to successfully create and configure the study build within our ClinSpark database. This involves thoroughly understanding the study protocol, extracting relevant information, and translating it into actionable items for database setup. The role ensures that all critical data collection elements are accurately captured and properly integrated into the ClinSpark system, facilitating seamless data management and analysis throughout the study. Additionally, it includes ongoing collaboration with the Clinical Applications Team to address any protocol changes or updates, ensuring the database remains aligned with study requirements and compliance standards.

Requirements

• Bachelor of Science in related field + 1 year as a Clinical Research Coordinator (CRC) or 3 years of experience in a clinical research environment.

Responsibilities

• Conducts clinical research in compliance with all applicable regulations, including but not limited to GCDMP, ICH GCP, and FDA 21 CFR Part 11 and company SOPs.
• Demonstrates knowledge and application of all privacy and safety standards as they relate to job responsibilities, human research subjects, staff, and the general operation of the unit.
• Interacts and communicates with, as well as delegates to (as necessary) all internal departments to achieve successful coordination during duration of study.
• Performs a comprehensive evaluation of the initial and subsequent versions of the protocol and informed consent forms prior to IRB submission.
• Maintains detailed knowledge and understanding of assigned protocols, including all protocol requirements for participant/subject visits, obtaining informed consent, visit schedules, tests, procedures, and laboratory information.
• Provides comprehensive protocol details and identifies key data collection points in a source template for ClinSpark electronic case report forms (eCRF).
• Performs a quality check review of all study data collection forms against the IRB approved protocol, protocol clarification letters, and other study specific documents and provides feedback.
• Attends project Kick-off meetings and Site Initiation Visits and any meetings between Sponsor and Pharmaron regarding the ClinSpark build and/or updates for the duration of the study.
• Confirms IRB approval has been obtained prior to study initiation and activation in ClinSpark.
• Confirms Sponsor has given signed approval for Clinspark activation.
• Maintains and shares Clinspark database plans and review logs.
• Maintains all final plans, logs and eCRFs for TMF filing.
• Confirms the details of study-specific laboratory specimen collection containers with the laboratory manager or designee.
• Performs a quality control review of the study-specific activity worksheets against the IRB approved protocol and ClinSpark eCRFs.
• Reviews EDC case report forms, when available, for each study against the IRB approved protocol and provide recommendations, as deemed necessary.
• Ensures ClinSpark eCRFs align with any EDC case report forms, if applicable.
• Reviews ClinSpark eCRFs and activity plans for each study against the IRB approved protocol and provide any recommendations, as necessary.
• Completes all ClinSpark User Acceptance Testing (UAT) including but not limited to initial testing and any updates throughout the study.
• Serves as the primary liaison for all other departments' proposed modifications to the eCRFs in ClinSpark.
• Communicates actively with Laboratory, Pharmacy, Clinical Operations, Medical Staff, Project Management, Biostatistics and Data Management throughout the study build process.
• Reviews clinical laboratory panels against the IRB approved protocol.
• Attends meetings with the Clinical Applications Team to provide feedback about current processes.
• Works in collaboration with the Project Manager to ensure database build timelines are met.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level