Lead, Clinical Research Associate - US

About the Role

Celerion is seeking a full-time Lead, Clinical Research Associate to oversee monitoring and site management activities for clinical trials, clinical investigations, and other interventional or non-interventional studies.

Responsibilities

Team Leadership and Line Management

• Direct supervision and line management of CRA staff and contractors in accordance with Celerion policies and applicable regulations.
• Interview, hire, and conduct onboarding training for new staff in conjunction with Human Resources; ensure staff has proper materials, systems access, and training.
• Prepare and implement function-specific training programs; ensure training on and adherence to Celerion’s procedures, guidance documents, best business practices, legal, and confidentiality constraints.
• Assign staff members to clinical projects, monitor workload, and liaise with the Manager of Monitoring to ensure appropriate resource allocation and optimal utilization.
• Ensure timely submission, review, and approval of timesheets and expense reports.
• Develop, mentor, manage, and coach CRA staff to maintain the organization's quality standards.
• Perform annual appraisals, define performance objectives, and advocate for individual career development, responsibility, and accountability.
• Serve as escalation line for direct reports, including troubleshooting, issue escalation, deviation management, and QI/CAPA management.
• Advocate for staff needs with other organizational functions.
• Generate action plans and provide developmental/strategic oversight to optimize monitoring services, focusing on high-quality delivery of individual, team, and departmental goals.
• Maintain a positive, results-oriented work environment, build partnerships, model teamwork, and communicate openly and objectively.
• Contribute to Process Improvement initiatives for the Line of Service (LOS).

Project-Related Responsibilities

• Support day-to-day execution of monitoring services for ongoing projects; ensure deliverables of assigned CRAs are met on time, within quality and budget parameters, according to Sponsor/Client expectations.
• Implement and monitor clinical studies to ensure compliance with local regulatory requirements, Good Clinical Practice, and the respective protocol or investigational plan:
  • Ensure monitoring activities occur according to contract, monitoring plan, and SOPs.
  • Oversee and assist with monitoring plan and study material development (e.g., SIV Slides, SQV Waivers).
  • 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 training with pertinent departments and vendors.
  • Review monitoring metrics/deliverables to evaluate quality trends and compliance with the monitoring plan.
• Interact with Sponsor/Client and participate in their meetings as necessary.
• Collaborate with Clinical Project Managers and study team members to resolve project issues promptly.
• Participate proactively in project study meetings and activities to enhance project progress.
• Participate in audits and inspections, including preparation and follow-up activities.
• Support Sponsor/Client in fulfilling regulatory submission obligations.
• Act as a CRA for selected studies where needed.

Additional Responsibilities

• Perform on-site and in-house tasks according to contractual agreements with Sponsor/Client.
• Follow all applicable procedures and policies (standard and study-specific).
• Interact with direct supervisor and study team to understand tasks, timelines, and priorities.
• Maintain working knowledge of all required Celerion IT systems.
• Follow administrative, reporting, and documentation requirements of Celerion and clients.
• Agree to audits, compliance, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associates.
• Perform other duties as assigned.

Requirements and Qualifications

• Bachelor's degree in a biomedical-related field, life sciences, or equivalent.
• At least 5 years in clinical operations or a related discipline within a CRO or Pharmaceutical industry, with a minimum of 3 years of onsite monitoring experience.
• People management skills required.
• Excellent oral and written communication skills in English.
• High level of organization, multi-tasking, judgment, and analytical skills.
• Good time management skills to ensure adherence to timelines.
• Profound knowledge of Good Clinical Practice, 21 CFR Part 11, and other relevant regulatory requirements.
• Dedication to quality and reliability.
• Commitment to continuous training and knowledge sharing; proactive in staying updated with procedural industry standards and international regulatory developments.
• Ability to work well independently and as part of a team.
• Self-motivation and strong attention to detail while being tactful and diplomatic.
• Maintain confidentiality of subject data and Sponsor/Client information.
• Computer literacy.
• Ability to conduct all types of site visits according to Celerion/Sponsor SOPs, GCP, and regulatory requirements.
• Experience in performing Feasibilities, Site Qualification Visits, Initiation Visits, Investigational Product Accountability, Routine Monitoring Visits, Close Out Visits, maintaining Trial Master Files, and handling SAEs.
• Flexible and willing to travel for both pre-planned and impromptu meetings/visits.

Celerion Values

• Integrity
• Trust
• Teamwork
• Respect