Jobs at Celerion

Support participant activities for clinical studies: screen and register participants, maintain study records and databases, collect and organize paperwork, communicate with panelists, and coordinate travel between Lincoln and Omaha sites. Work Monday–Friday with emphasis on organization and participant relations.

Develop and validate ligand-binding immunoassays (ELISA, MSD, etc.) for PK/PD/biomarkers and ADA, analyze and troubleshoot data, lead method development projects, support regulatory-compliant studies, collaborate cross-functionally, author scientific communications, and engage with clients.

Support development of bioanalytical scopes, budgets, and pricing; prepare proposals, RFQs, and contracts; manage project financials (forecasting, WIP, invoicing); maintain systems and templates; improve processes using Smartsheet, AI, and automation; coordinate cross-functionally to ensure accurate, compliant proposals and project financial alignment.

Manage Consumer Opinion Center operations and staff in Richmond, ensuring compliance, quality, client satisfaction, scheduling, study setup, survey/ballot creation, reporting, and audit responses.

Responsible for subject safety and executing IRB-approved clinical trial protocols per FDA and GCP. Duties include pre-study review, consenting and screening subjects, conducting exams, managing and reporting adverse events/SAEs, reviewing CRFs and study data, coordinating with sponsors and IRB, designing study procedures, maintaining physician networks, and supporting SOPs, training, and emergency response.

Lead GLP/GxP-compliant bioanalytical studies and method validations as Study Director/Principal Investigator. Serve as primary client contact, oversee study planning through reporting, review analytical data for regulatory compliance, mentor laboratory staff, coordinate lab operations, and support process improvements and client-facing scientific activities.

Support development of bioanalytical study scopes, budgets, and pricing. Prepare proposals, RFQs, and contracts; monitor project financials, forecasting, invoicing, and WIP. Improve pricing tools and Smartsheet workflows, use AI/automation for efficiency, and assist with ordering study-specific materials.

Define, develop, implement and maintain global SOPs and standards for clinical research. Lead cross-functional groups, manage document control, ensure regulatory and QMS compliance, and develop process training.

Lead and manage the bioanalytical QA team to ensure compliance with GLP/GCP and 21 CFR Part 11, oversee study, system, and vendor audits, host sponsor audits and regulatory inspections, drive QMS and process improvements, and contribute to global QA strategy.

Provide on-site IT desktop, server, and network support for the Zurich site, acting as primary IT contact. Handle IMAC activities, endpoint deployment/imaging (Intune, SCCM/MECM, Autopilot), Active Directory and Windows Server tasks, Citrix and Oracle client support, basic SQL/ODBC configuration, local cabling and switch troubleshooting, ticket resolution, backups/restores, and ensure compliance with GxP and change-control procedures. Deliver onboarding and end-user training and coordinate with global IT teams for escalations.

Set up and maintain clinical trials in ClinQuick EDC. Create study conduct instruction manuals and detailed timed event schedules for clinic staff and participants. Manage logistical study setup and ensure accurate documentation in a fast-paced clinical research environment.

Build and administer EDC trials including eCRF design and EDC builds, program edit checks, create test data and environments, execute UAT coordination, program reports/listings with Veeva CDB, manage secure data imports, validate system upgrades, and maintain CDISC database standards.

Manage and conduct clinical bioequivalence/bioavailability studies, ensure compliance and quality, coordinate with support teams, organize study logistics and meetings, interact with clients, and maintain study profitability and timelines. May work evenings and weekends.

Support development of scopes, budgets, and pricing for bioanalytical studies; prepare proposals, RFQs, and contracts; manage project financials, forecasting, invoicing, and close-out; optimize pricing tools and Smartsheet workflows and use automation to improve processes.

Perform scheduled study events per protocol, collaborate with study managers, conduct vital signs, ECGs, blood draws and telemetry monitoring, identify and report adverse events, and document study activities. Work 4x10 shifts (05:00–17:00) with one weekend per month.

Lead technical conduct of small-molecule bioanalytical studies: serve as primary client contact, review protocols and sample analysis plans, approve reports and QA audits, oversee training, manage deviations and investigations, and ensure data integrity.