Celerion

Designer

• Lead global project groups to obtain information needed to create global process documents.
• Plan for and manage reviews of new and existing processes and standards to ensure completeness, consistency, quality and compliance with established requirements.
• Manage document control and maintenance process for all Celerion processes and standards.
• Ensure processes and standards are compliant with regulatory requirements, corporate governances and the Quality Management System.
• Develop, coordinate and facilitate training programs for appropriate processes and standards.

Standard Operating Procedure Designer

Director

• Design and lead the global training and onboarding function
• Collaborate with leadership and existing SME experts to evaluate and recommend training initiatives
• Focus on the development and expansion of programs for skill-based, compliance, and professional development training
• Assess, strategize, and execute while collaborating with all units of the organization
• Shape the future of talent development on a global scale

Director, Global Training and Development

QA Engineer

• Perform comprehensive User Acceptance Testing (UAT) on clinical databases and related systems
• Create and execute detailed test scripts based on database specifications
• Coordinate with CDMs participating in UAT – providing them with test schedules, test data, direction, and detailed test scripts in accordance with study timelines
• Validate database libraries and system configuration changes per GxP requirements
• Maintain complete validation documentation in compliance with departmental SOPs
• Collaborate with multidisciplinary study teams to establish and meet timelines
• Proactively identify risks and escalate issues to management and study team members
• Communicate progress updates and coordinate testing schedules with stakeholders
• Deliver all study deliverables on time per agreed timelines
• Analyze system needs and evaluate workflow solutions
• Participate in onboarding and validation of new systems and processes
• Assist with the validation of upgrades to hardware/ software including validation documentation development, review and execution.

EDC Test Analyst

Software Engineer

• Serve as a subject matter expert in Veeva Clinical Data Management Suite (CDMS), including Veeva Electronic Data Capture (EDC) and Veeva Clinical Database (CDB)
• Perform all activities related to eCRF design and EDC build programming for assigned projects
• Perform EDC edit check programming for assigned projects based on edit check specifications for both simple and complex edit checks
• Create test data to verify both screen design and edit check programming prior to deploying to User Acceptance Testing (UAT)
• Set up test environments and coordinate project team members for execution of test scripts
• Program and configure listings and reports using clinical reporting tools such as Veeva Clinical Database (CDB)
• Ensure secure and high-integrity database imports from vendor transfers using Celerion data transfer standards
• Assist with the validation of upgrades to hardware/ software including validation documentation development, review and execution.
• Maintain global clinical trial database standards (CDISC)

EDC Developer, Programmer

Clinical Research

• Overall management and oversight of assigned Clinical Studies.
• Ensure on-time performance with defect-free execution of studies working with support divisions (recruiting, data management, statistics).
• Organize study initiation meetings to plan execution.
• Facilitate study review meetings for pre-study, in-process and post-study review.
• Problem solve during study conduct and be present at critical events and dosing.
• Meet with clients throughout study and build client relationships.
• Organize study logistics and personnel.
• Craft and edit reports and respond to client issues, concerns and requests.
• Adhere to milestone guidelines and ensure profitability through budgeting and expense control.

Clinical Study Manager I

Bilingual

• Assist Admissions team to complete screening processes for each clinical study
• Maintain good relations with study participants during the admissions process
• Assist with participant screenings and call backs
• Complete data entry of participant information
• Assist with lab coordination and prepare study project calendars
• Translate and communicate with Spanish-English speaking participants
• Work flexible schedule to meet screening needs, including early mornings and occasional Saturdays
• Work 30-40 hours/week, mainly Monday–Friday

Medical Admissions Assistant, Spanish Bilingual

Clinical Operations

• Independently manage initiation, maintenance and close-out activities of multi-center clinical studies ensuring compliance with protocol, SOPs, ICH GCP and regulatory/local requirements
• Plan and procure team resources to complete study activities according to scope, budget, and timeline
• Develop and/or oversee study plans (project management, monitoring, risk management, data management, safety)
• Coordinate activities with central laboratories and other external service providers/vendors
• Review and negotiate site budgets and contracts and participate in change orders to sponsor/site contracts and budgets
• Maintain effective communication with sponsor, external service providers, and internal departments to ensure successful project completion

Clinical Project Manager

• Perform scheduled events according to the study protocol
• Work directly with study managers to ensure successful trial execution
• Work with research participants performing vital sign checks, ECGs, blood draws and telemetry monitoring
• Identify and report adverse events to assist in the clinical research process
• Assist with clinical research trials involving a healthy population and learn drug development processes
• Weekend day shift responsibilities (Saturday and Sunday 2x12 hour shifts)

Clinical Research Nurse

• Responsible for receipt, storage, preparation, disposition, and retention of all study investigational products in compliance with standard operating procedures, FDA, and DEA regulations concerning investigational product handling, accountability and security. Review and understand study protocol requirements in regard to investigational product handling.
• Active member of study team providing expertise and support such as evaluating study feasibility, study set up and conduct, participating in internal and/or external client meetings. Provide internal and/or external client communication and interaction regarding investigational product handling and protocol specific requirements.
• Knowledge of relevant United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs required.
• Maintain aseptic compounding evaluation requirements.
• Provide training and monitoring for administration of investigational products as needed.
• Review and provide input to standard operating procedures and training plans pertaining to pharmacy and assisting with pharmacy training as necessary.
• Maintain pharmacy department equipment and applicable records as necessary.
• Institutional Review Board consultant and resource.
• Assist in training of new hires and students.
• Additional Essential Functions if assigned the “Designated Person” role: Work with the Pharmacist in Charge to ensure compliance with current USP guidelines and applicable Celerion SOP’s pertaining to extemporaneous pharmacy compounding; Review applicable compounding SOP’s every 12 months to ensure continued compliance with USP guidelines and implement changes, as appropriate; Ensure the CAPA system is initiated when warranted; Oversee pharmacy personnel compounding training program; Oversee compliance with USP guidelines; Oversee monitoring of the Designated Compounding Areas; Review and maintain all pharmacy compounding certification records (personnel and facility) to ensure completeness and compliance; Recognize problems, deviations, failures, and errors in the compounding process and the facility and report all issues to the Pharmacist in Charge.

Clinical Research Pharmacist

• Drive and lead development and implementation of regulatory-quality chromatographic methods to progress sponsor drug development programs
• Provide management, technical and scientific leadership to Method Development, Instrumentation and Bioanalytical Principal Investigator teams to foster collaboration and cohesive teams
• Conduct and measure performance evaluations through SMART goal setting and regular feedback to ensure high performance and equitable development opportunities
• Ensure the assigned laboratory meets planned revenue, operating margins, client timelines, quality and turnaround times
• Develop and implement strategic equipment and resourcing plans for the chromatography laboratory
• Ensure timely and scientifically robust development, validation and production of chromatographic methods to applicable regulatory standards and client expectations
• Facilitate and promote a proactive quality management culture of continuous improvement and operational efficiency, collaborating with global BAS and QA
• Ensure all work is performed according to GLP/GCP and EHS principles and controlled documents are followed
• Investigate potential growth opportunities with BAS Senior Management and increase Celerion’s presence in the bioanalytical community through collaborations, meetings, presentations and publications
• Support Business Development and Client Relations as a Subject Matter Expert in capability presentations, input to proposals, and pricing assumptions
• Participate in client and regulatory audits and support department leadership in driving customer satisfaction and relationship building

Director, Chromatography

Call Center Representative

• We are seeking a Call Center Team Leader at our Richmond, Virginia site. This is a full time benefited role, working 40 hours per week, Monday - Friday 11:30am - 8:00pm. This site provides consumer research for nicotine and tobacco studies.
• The Call Center Team Leader is responsible for providing assistance to the Manager for a team of Participant Recruiters. The Call Center Team Leader assists the Call Center Manager in the development of staff, intra-department communications, operations, scheduling and customer service initiatives.
• Essential Functions:
• Staff Management
• Responsible for execution of departmental objectives and adherence to company policies and procedures
• Assist in departmental training to include; shadowing, document development etc.
• Serve as the communication link between Participant Recruiters and the Call Center Manager
• Assist Call Center Manager in staff development
• Address study participant complaints and staff complaints through resolution according to policies and procedures
• Schedule staff and distribute assignments
• Assist Call Center Manager in providing feedback to staff on call center performance measures, call statistics and attendance
• Develop and implement fun and creative incentive programs
• Recruiting Operations
• Responsible for planning and executing recruiting functions, this includes but is not limited to:
• Sending daily reminders to staff on study priorities
• Creating recruiting lists and coordinating recruiting efforts
• Salesforce and board tracking set-up for recruiting
• Sending panel communications via the control panel
• Ensuring accurate and timely report of recruiting status
• Monitoring recruiting statuses and ensuring that timelines are met
• Manage the quality monitoring program
• Perform all Participant Recruiter functions based on business need or at the request of call center management
• Maintain level of supplies needed for the call center (i.e. notepads, markers, pens, postcards...etc.)
• Act as the first line of escalation for study participant issues or concerns
• Conduct study audits to ensure compliance to recruiting requirements outlined in the Study Synopsis
• Attend weekly meetings with supervisor
• Reporting
• Compile and report metrics to Call Center Manager and/or leadership team as requested, including but not limited to:
• Recruiting Updates
• Confirmation Reports
• Call Stats

Call Center Team Leader

Medical writer

• Celerion is committed to swift, exceptional clinical research through translational medicine.
• Full-time Medical Writer, home based anywhere in the United States; Canada and non-US candidates will not be considered.
• Analyze and interpret safety results of clinical trials, including vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and pharmacodynamic (PD) endpoints.
• Compile, write, and edit Phase I and Phase II clinical study documents including clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs.
• Confirm accurate classification of events and medications using standardized coding systems.
• Perform peer QC of safety text, serve as project Report Lead, monitor editorial comments, and ensure regulatory compliance (GCP, ICH) and client specifications.
• Use technology to collaborate with international teams (Veeva, Microsoft 365, SharePoint, SmartSheet), lead client communications, and interact with internal departments.

Medical Writer

Data Analyst

• Provide statistical programming support for early-phase clinical research at Celerion, designing, developing, and maintaining SAS programs to support analysis and reporting of clinical trial data.
• Independently develop, maintain, and process SAS programs, creating analysis data packages (ADaM), statistical analyses, data listings, tables, and figures.
• Perform peer QC, double programming, and validation functions for statistical outputs from studies.
• Lead statistical programming activities on studies and deliverables; assist management and biostatisticians with complex projects.
• Design and implement standardized SAS programs; train and mentor junior programmers; ensure compliance with the statistical analysis plan and departmental procedures.

Senior Data Analyst, Statistical Programming

Research Analyst

• Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
• Celerion, a leader in clinical research, is seeking a full-time Clinical Research Associate (CRA) to perform monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies.
• This is a Hybrid position - We are looking for someone that currently lives in the Phoenix, Arizona area - and that is able to go to the Tempe sites on a regular basis.