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About the Role

The Clinical Site Director is responsible for driving operational performance for the research site. Provides on-site oversight to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, and FDA guidelines and follows company policies and procedures.

Responsibilities

• Overall site management and leadership with a focus on driving site performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance.
• Collaborate with department leaders to coordinate delivery expectations, meet study milestones, budgets, and deliver quality data.
• Review performance dashboards and clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and timely operational execution.
• Oversee resourcing allocations, site assignments, and study team members' output and performance, identifying and escalating risks to deliverables.
• Assist with initial and ongoing trainings regarding protocol specificities, CRF completion, SOPs, clinical plans and guidelines, and timelines.
• Ensure adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies.
• Oversee site staff assigned to the study, assessing process and training compliance, and identifying emerging risks.
• Develop and support execution of corrective action plans at site and study level.
• Oversee people management activities including interviewing, selection, performance appraisals, job description preparation, employee counseling, career coaching, and termination meetings.
• Manage site staff, proactively identify and resolve issues, and ensure successful site operations.
• Oversee payroll, absence tracking/approvals, new hire orientation, and training.
• Collaborate with investigators to ensure patient safety and meet client goals and timelines.
• Employ strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participate and present in management or site meetings.
• Perform all other duties as required or assigned.

Requirements

• A Bachelor’s degree AND 5+ years of clinical research experience or an equivalent combination of education and experience is required.
• 2+ years of clinical research site management experience is required.
• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
• Strong organizational, time management, problem solving, and project management skills to meet project deadlines.
• Well-developed written and verbal communication skills.
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
• Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
• Must be professional, respectful of others, self-motivated, and have a strong work ethic.
• Must possess a high degree of integrity and dependability.
• Ability to work under minimal supervision, identify problems and implement solutions.
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

Skills

• Bi-lingual (English / Spanish) proficiency is preferred.

Location

• North Georgia Clinical Research - Woodstock, GA

Work Type

• Full Time

Experience Level

• 5+ years of clinical research experience
• 2+ years of clinical research site management experience

Education Level

• Bachelor’s degree

Benefits

• Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.

About the Company

• Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico.
• We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine.
• Join us as we continue to grow.