Clinical Informatics Specialist

Location: Baltimore, MD (On-site / Hybrid / Remote)

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services. We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADCs, biologics, and gene therapies and we work with more than 3,300 global customers.

Responsibilities

• Provide comprehensive protocol details and identify key data collection points necessary for the Clinical Applications Team to successfully create and configure the study build within our ClinSpark database.
• Thoroughly understand the study protocol, extract relevant information, and translate it into actionable items for database setup.
• Ensure all critical data collection elements are accurately captured and properly integrated into the ClinSpark system, facilitating seamless data management and analysis throughout the study.
• Collaborate with the Clinical Applications Team to address any protocol changes or updates, ensuring the database remains aligned with study requirements and compliance standards.
• Conduct 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.
• Demonstrate 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.
• Interact and communicate with, as well as delegate to (as necessary), all internal departments to achieve successful coordination during the duration of the study.
• Perform a comprehensive evaluation of the initial and subsequent versions of the protocol and informed consent forms prior to IRB submission.
• Maintain 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.
• Provide comprehensive protocol details and identify key data collection points in a source template for ClinSpark electronic case report forms (eCRF).
• Perform a quality check review of all study data collection forms against the IRB approved protocol, protocol clarification letters, and other study-specific documents and provide feedback.
• Attend project Kick-off meetings, Site Initiation Visits, and any meetings between Sponsor and Pharmaron regarding the ClinSpark build and/or updates for the duration of the study.
• Confirm IRB approval has been obtained prior to study initiation and activation in ClinSpark.
• Confirm Sponsor has given signed approval for ClinSpark activation.
• Maintain and share ClinSpark database plans and review logs.
• Maintain all final plans, logs, and eCRFs for TMF filing.
• Confirm the details of study-specific laboratory specimen collection containers with the laboratory manager or designee.
• Perform a quality control review of the study-specific activity worksheets against the IRB approved protocol and ClinSpark eCRFs.
• Review EDC case report forms, when available, for each study against the IRB approved protocol and provide recommendations, as deemed necessary.
• Ensure ClinSpark eCRFs align with any EDC case report forms, if applicable.
• Review ClinSpark eCRFs and activity plans for each study against the IRB approved protocol and provide any recommendations, as necessary.
• Complete all ClinSpark User Acceptance Testing (UAT) including but not limited to initial testing and any updates throughout the study.
• Serve as the primary liaison for all other departments' proposed modifications to the eCRFs in ClinSpark.
• Communicate actively with Laboratory, Pharmacy, Clinical Operations, Medical Staff, Project Management, Biostatistics, and Data Management throughout the study build process.
• Review clinical laboratory panels against the IRB approved protocol.
• Attend meetings with the Clinical Applications Team to provide feedback about current processes.
• Work in collaboration with the Project Manager to ensure database build timelines are met.

Requirements

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

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

Pay

$24.00/hr. - $30.00/hr.