Our client, a leading Life Sciences company, is hiring a Lead Study Coordinator.

Work Location: Maricopa County, Arizona

Summary:

We are seeking an experienced Lead Clinical Research Coordinator (CRC) to oversee clinical trial operations at our research site. The ideal candidate will bring both hands-on clinical research experience and operational leadership skills to manage multiple studies, mentor junior staff, and ensure the highest standards of regulatory compliance and patient care. This role combines direct study coordination with site-level operational responsibilities and team leadership.

Responsibilities:

Clinical Trial Management

• Serve as lead coordinator for complex, high-enrollment clinical trials across multiple therapeutic areas
• Oversee patient recruitment, screening, enrollment, and retention strategies
• Conduct study visits, including informed consent, protocol procedures, and data collection
• Ensure accurate and timely completion of case report forms and source documentation
• Manage investigational product accountability and regulatory file maintenance

Operations & Site Management

• Develop and implement standard operating procedures to optimize site efficiency
• Monitor study budgets, invoicing, and resource allocation across the portfolio
• Coordinate site readiness activities including feasibility assessments and site qualification visits
• Manage relationships with sponsors, CROs, and monitoring teams
• Identify operational bottlenecks and implement process improvements
• Oversee scheduling systems and ensure optimal patient flow

Team Leadership & Mentorship

• Supervise, train, and mentor clinical research coordinators and support staff
• Conduct performance evaluations and provide ongoing professional development
• Delegate study responsibilities and ensure workload balance across the team
• Lead team meetings and foster a collaborative, learning-focused culture
• Serve as primary point of escalation for study-related issues

Regulatory Compliance & Quality

• Ensure adherence to ICH-GCP, FDA regulations, and institutional policies
• Prepare for and support regulatory audits and sponsor monitoring visits
• Maintain inspection readiness and implement corrective action plans as needed
• Track and report protocol deviations and adverse events per regulatory requirements

Qualifications:

• Bachelor's degree in life sciences, nursing, or related field (or equivalent experience)
• Current CCRP, CCRC, or equivalent certification preferred
• Minimum 5 years of clinical research coordination experience
• At least 2 years in a lead, senior, or supervisory role
• Demonstrated experience managing site operations and improving workflows
• Experience across multiple phases of clinical trials (Phase I-IV)
• Track record of successful regulatory inspections and audit outcomes
• Strong knowledge of ICH-GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), and HIPAA
• Excellent organizational and time management skills with ability to prioritize competing demands
• Proven leadership abilities with experience mentoring and developing team members
• Strong interpersonal skills and ability to build relationships with diverse stakeholders
• Proficiency with EDC systems, CTMS, and clinical research software
• Critical thinking and problem-solving capabilities
• Attention to detail with commitment to data quality and patient safety
• Advanced degree (MS, MPH, MBA) or nursing license (RN, LPN) preferred
• Experience with specific therapeutic areas [list relevant areas for your site] preferred
• Previous experience in site startup and feasibility assessments preferred
• Knowledge of clinical trial budgeting and contract negotiation preferred
• Experience implementing quality improvement initiatives preferred

Published Category: Clinical Operations & Development