Celerion

QA Engineer

• Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to Clinical Study Report audits, Protocol audits and Electronic Database Capture (EDC) audits).
• Interact with internal and external clients to discuss QA observations and study-related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
• Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
• Detect quality issues and the need for CAPAs and evaluate deviations
• Assist with the preparation for and hosting of client audits and/or regulatory inspections.
• Participate in the preparation, conduct and follow-up for System Audits and Vendor Audits

Quality Assurance Auditor

Clinical Operations

• Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, relevant SOPs, Good Clinical Practice, international standards, and regulatory requirements
• Plan and procure team resources as needed to complete study activities according to scope, budget, and timeline
• Develop and/or oversee development of study plans such as project management (including communication), monitoring, risk management, data management and safety plans
• Coordinate activities with central laboratories and other external service providers/vendors
• Review and negotiate site budgets and contracts
• Initiate and participate in the development of change orders to sponsor and/or site contracts and budgets
• Maintain appropriate and effective communication with sponsor, external service providers, and other internal departments to ensure successful project completion

Clinical Project Manager

Project Manager

• Support day-to-day management of studies, ensure within the Study Team that project/study tasks are delivered in time, within the budget, and according to Sponsor/Client expectations, in close cooperation with designated Project Team
• Support the implementation and maintenance of studies; assist so that Sponsor and Investigator obligations are met and are in compliance with applicable regulatory requirements (including local law) as well as Good Clinical Practice
• Support in document management (creation, review, collection, filing, forwarding) including submission documents, meeting minutes and Trial Master Files, from Pre-study Phase to Study Closure
• Support (field) monitors by (but not limited to) preparing checklists, controlling completion status and timelines, updating relevant tracking sheets
• Create, review, finalize, forward and file meeting minutes for all internal and external study-related meetings.
• Support in Celerion process improvement
• Support in-house in performing site feasibility and site qualification visits in order to select qualified sites
• Support to prepare documents for Site Initiation Visits (SIVs), such as presentation slides
• Support to prepare documents for Monitoring Visits
• Support to prepare documents for Close-out Visits
• Perform content review and quality checks of received documents
• Cooperate with central TMF team to keep Trial Master File (TMF) up-to-date and track filed documents
• Support query resolution in a timely manner
• Support Serious Adverse Event (SAE) reporting according to study specifications
• Support in document/review study status, site enrolment status
• As a member of Celerion’s project teams, perform billable work in accordance with Celerion BCDs, SOPs and PGs, and within the relevant timelines
• Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary
• Participate and demonstrate proactive involvement in project/study meetings, internal project/study meetings, and other activities enhancing project progress
• Participate in audits and inspections, including preparation and follow-up activities
• Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements

Clinical Project Coordinator

Call Center Representative

• Answer inbound calls from members of the public interested in participating in our Phase 1 clinical drug trials.
• Screen callers for study eligibility.
• Collect and enter personal data for those eligible to participate.
• Make outbound calls to schedule appointments, as needed.

Call Center Quality Specialist

Account Executive

• Are you a driven bioanalytical inside sales professional looking to thrive in a dynamic and fast-paced environment where your efforts directly fuel business growth? If so, we can’t wait to meet you.
• Celerion is hiring a remote Inside Sales Representative to support the growth in our Clinical, Biometrics, & Bioanalytical business. You will be working closely with Business Development to expand and accelerate lead generation for the US and EU.
• In this role, you will focus on initiating contact with potential clients to understand their specific clinical, biometrics, & bioanalytical needs and challenges. You will facilitate an introduction with Business Development to further cultivate accounts.  You will bring your ability to manage lead generation with Zymewire, & LinkedIn and engage in presenting Celerion’s differentiated services to potential clients.
• This role offers a base salary plus commission structure and room for growth with strong performance.

Quality Assurance Auditor

Clinical Project Manager

Clinical Project Coordinator

Call Center Quality Specialist

Inside Sales Representative, Clinical, Biometrics, Bioanalysis Services