We are seeking an experienced Clinical Site Director to lead daily operations at a clinical research site. This individual will be responsible for improving site performance, overseeing clinical trial activities, managing research personnel, and ensuring studies are conducted in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and established protocols.
The ideal candidate combines strong clinical research experience with proven leadership, operational management, and team development skills. This role requires the ability to balance study execution, participant safety, regulatory compliance, staff performance, and business objectives.
Key Responsibilities
- Provide overall leadership and operational oversight for clinical research site activities, with an emphasis on efficiency, performance, participant safety, and regulatory compliance.
- Collaborate with internal teams responsible for recruitment, business development, finance, contracts, and quality assurance to achieve enrollment goals, study activation milestones, budget targets, and data quality expectations.
- Monitor site performance metrics and clinical trial systems to evaluate study progress, participant activity, staff coverage, and timely completion of required procedures.
- Manage resource allocation, staff assignments, and team productivity to ensure study deliverables remain on schedule and within established quality and budget expectations.
- Identify operational challenges, enrollment barriers, staffing concerns, and potential risks to study timelines, escalating issues and implementing solutions as appropriate.
- Coordinate staff training on study protocols, data collection requirements, standard operating procedures, clinical research guidelines, and project-specific timelines.
- Ensure adherence to applicable regulatory requirements, Good Clinical Practice (GCP), FDA guidelines, internal procedures, and participant confidentiality standards.
- Evaluate staff compliance with study-specific processes, training requirements, and quality expectations, identifying opportunities for improvement.
- Develop and implement corrective and preventive action plans to address operational issues and strengthen site performance.
- Oversee personnel management, including interviewing, hiring, onboarding, performance reviews, employee coaching, professional development, and disciplinary actions when necessary.
- Manage staffing needs, attendance tracking, payroll coordination, and employee training to maintain effective site operations.
- Partner with principal investigators and other clinical stakeholders to support participant safety, protocol compliance, and successful study execution.
- Apply strategic thinking and problem-solving skills to improve workflows, mitigate risks, and support operational growth.
- Participate in leadership meetings and site reviews, communicating operational updates, performance trends, challenges, and improvement initiatives.
- Complete additional duties as needed to support site operations and organizational objectives.
Qualifications and Experience
Minimum Qualifications
- Bachelor's degree and at least five years of clinical research experience, or an equivalent combination of education and professional experience.
- At least two years of clinical research site management experience.
- English and Spanish bilingual proficiency preferred.
Required Skills and Competencies
- Proficiency with Microsoft Office, email, electronic health records, web-based applications, and clinical research systems.
- Strong organizational, time management, project management, and problem-solving skills.
- Excellent written and verbal communication skills.
- Strong interpersonal skills and the ability to collaborate effectively with research personnel, investigators, participants, leadership, and external partners.
- Ability to manage multiple responsibilities, adapt to changing priorities, and meet deadlines in a fast-paced environment.
- Demonstrated professionalism, initiative, accountability, and a strong work ethic.
- High degree of integrity, reliability, and attention to detail.
- Ability to work independently, identify operational challenges, and implement effective solutions with minimal supervision.
- Ability to maintain confidentiality and appropriately handle sensitive information in accordance with HIPAA and applicable privacy requirements