Lead, Clinical Monitoring Services - Arizona

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 angstin clinical research, is seeking a full-time Lead, Clinical Monitoring Services person to oversee monitoring and site management activities for clinical trials, clinical investigations, and other interventional or non‑interventional studies. This person will need to live within a couple of hours of our Tempe, Arizona location.

• 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 falou the same.
• 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得 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伍 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 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.
• Partic…