Celerion

Research Analyst

• Provide experienced leadership to a team of Clinical Research Associates involved in clinical studies that are executed at the sites conducting clinical research studies This includes, but is not limited to:
• Direct supervision / line management of CRA staff and contractors in the team in accordance with Celerion policies and applicable regulations.
• Interview, hire, and conduct onboarding training for new staff in conjunction with Human Resources; ensure that staff has the proper materials, systems access and training to complete job responsibilities.
• Prepare and implement function specific training programs; ensure training on and adherence to Celerion’s procedures and guidance documents, best business practices, legal and confidentiality constraints.
• Assign staff members to clinical projects, monitor staff workload, and liaise with the Manager of Monitoring, GCD North America (as needed) to ensure appropriate allocation of resources and optimal utilization.
• Ensure timely submission of timesheets and expense reports by staff as well as review/approve timesheets and expense reports in a timely manner.
• Develop, mentor, manage and coach CRA staff to progress their skills so that the organization's quality standards are maintained.
• Perform annual appraisals, define the performance objectives and advocate individual career development, responsibility and accountability.
• Serve as escalation line for direct reports, including trouble shooting, issue escalation, deviation management, QI/CAPA management.
• Advocate for the needs of the staff with other functions of the organization.
• Generate action plans and provide developmental/strategic oversight to optimize monitoring services, with a focus on high quality delivery of individual/team/departmental goals.
• Maintain a positive, results oriented work environment, build partnerships, model teamwork, and communicate in an open, balanced, and objective manner.
• Contribute to Process Improvement initiatives for Line of Service (LOS)
• Support day-to-day execution of monitoring services for the ongoing projects; ensure deliverable of the CRAs assigned to the projects are met on time within quality and budget parameters according to the Sponsor/Client expectations. This includes, but is not limited to:
• Implementation and monitoring of clinical studies to ensure sponsor and investigator obligations are being met in compliance with local regulatory requirements, Good Clinical Practice, and the respective protocol or investigational plan as follows:
• Ensure monitoring activities are occurring according to contract, monitoring plan and SOPs.
• Oversee and assist with monitoring plan and study material development (SIV Slides, SQV Waivers, etc.).
• Co-monitor as needed.
• Update and review of clinical trial management tracking systems (CTMS).
• Manage all monitoring activities within CTMS (visits, open and closed queries, issues opened).
• Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings/training with pertinent departments and other vendors.
• Review monitoring metrics/deliverables to evaluate quality trends and compliance to monitoring plan.
• Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary;
• Interact with Clinical Project Manager/designate and other study team members to ensure timely resolution of project study issues.
• 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 as needed.
• Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements.
• May act as a CRA for selected studies where needed and defined.
• Perform on-site and in-house tasks according to contractual agreements with Sponsor/Client.
• Be thoroughly familiar with and follow all applicable procedures and policies (standard and study specific).
• Interact with direct supervisor and the study team to develop a thorough and unambiguous understanding of all tasks required as well as project study timelines and priorities.
• Maintain a working knowledge of all required Celerion IT systems.
• Follow administrative and reporting/documentation requirements of Celerion and clients , as necessary.
• Agree to be subjected to audits, compliance, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associates.
• Perform other duties as assigned.

Lead, Clinical Research Associate

Data Scientist

• Oversight of all clinical data management activities for assigned studies in accordance with SOP’s and Procedure Guides
• Primary Sponsor contact for data management processes on study
• Responsible for regular communication of study progress with internal and external project team
• Oversee CRFs from the creation of the blank CRF through delivery of final CRF to sponsor
• Ensure database is set up per specifications and perform User Acceptance Testing (UAT) of clinical database
• Coordinate creation of Data Management Plan, CRF Completion Guidelines, Data Validation Plan, and other study documents required per SOP and study needs
• Manage clinical data cleaning and delivery activities up to and including database lock
• Review clinical data to ensure accuracy, quality, and integrity of data
• Generate, resolve, and track queries to address discrepant data identified during review
• Perform third party data reconciliations
• Coordinate data transfers (clinical data and vendor related data) with assigned Data Programmer and Sponsor contact
• Proactively ensure on-time delivery of study deliverables through monitoring of study timeline commitments
• Manage and appropriately handle/archive all CDM study materials (internally and sponsor specific)
• Proactively assess project activities and identify issues and/or risk
• Provide high level customer service to all internal and external clients
• Perform Quality Control reviews on studies, as needed

Lead, Clinical Research Associate

Clinical Data Manager