Site Director

Medix; Decatur (GA); On-site; USD 95,000 - 130,000; Full time

Job summary

Medix is seeking an experienced Site Operations Manager to oversee day-to-day clinical site activities in Decatur, GA. You will coordinate with BD, finance, contracts, and quality teams to achieve activation and enrollment goals while ensuring budget alignment and data quality.

You will monitor performance dashboards, manage staffing, and ensure compliance with GCP, ICH, and FDA guidelines. This role requires a Bachelor’s degree and 5+ years in clinical research with strong leadership and

Qualifications

• Bachelor's degree in a relevant field or equivalent experience.
• Minimum of five years of clinical research experience.
• At least two years experience managing clinical research site operations.

Responsibilities

• Direct day-to-day site operations and establish priorities to support productivity and patient safety.
• Partner with cross-functional teams to coordinate operational needs and enrollment goals.
• Monitor dashboards and study management systems to assess progress and data quality.
• Evaluate staffing needs and workload distribution to meet timelines and quality standards.
• Identify risks and implement mitigation strategies for enrollment, timelines, data quality, and compliance.
• Coordinate training on study protocols, CRFs, SOPs, and timelines.
• Ensure compliance with GCP, ICH, FDA regulations and internal procedures.
• Oversee staff performance, training, documentation, and corrective actions.
• Lead recruitment, hiring, performance evaluations, and staff development.
• Ensure appropriate scheduling, timekeeping, and onboarding to maintain coverage.

Skills

Clinical operations leadership

Staff management

Regulatory compliance

Project management

Communication skills

Bilingual English/Spanish

Team collaboration

Education

Bachelor's degree in life sciences or related field

5+ years of clinical research experience

2+ years managing clinical site operations

Tools

Microsoft Office suite

Electronic Health Records (EHR) systems

Clinical Trial Management Systems (CTMS)

Job description

Direct day-to-day site operations, establishing priorities that support productivity, operational efficiency, patient safety, enrollment performance, and compliance with study protocols and regulatory requirements.

Partner with business development, patient recruitment, finance, contracts, and quality teams to coordinate operational needs, achieve site activation and enrollment goals, maintain budget expectations, and deliver accurate, high-quality study data.

Monitor operational dashboards, clinical trial management systems, and other performance metrics to assess study progress, staff coverage, patient activities, and completion of required visits, calls, and follow-up activities.

Evaluate staffing needs, study assignments, workload distribution, and team performance to ensure deliverables remain on schedule and within established quality standards.

Identify potential risks involving enrollment, timelines, data quality, staffing, or compliance, escalating concerns and implementing appropriate mitigation strategies.

Coordinate initial and ongoing training related to study protocols, case report form (CRF) completion, standard operating procedures (SOPs), clinical guidelines, study-specific requirements, and project timelines.

Ensure site operations comply with applicable regulatory requirements, Good Clinical Practice (GCP), ICH guidelines, FDA regulations, internal procedures, and study protocols.

Oversee staff adherence to study-specific processes, required training, clinical management plans, and documentation standards; identify gaps and implement corrective measures as needed.

Develop, coordinate, and monitor corrective and preventive action plans to address operational, quality, or compliance concerns.

Lead personnel management activities, including recruitment, interviewing, hiring decisions, performance evaluations, employee development, coaching, conflict resolution, disciplinary actions, and separations.

Oversee staff scheduling, timekeeping, leave requests, onboarding, orientation, and training to ensure appropriate coverage and operational continuity.

Collaborate with principal investigators and other clinical stakeholders to protect participant safety, support protocol execution, and meet study objectives and sponsor expectations.

Apply strategic planning, analytical thinking, and problem-solving skills to improve site performance and address operational challenges.

Participate in leadership discussions, site meetings, and performance reviews, providing updates on progress, challenges, and improvement initiatives.

Perform other duties as assigned to support site operations and organizational objectives.

Qualifications

Education and Experience

Bachelor's degree and at least five years of clinical research experience, or an equivalent combination of education and relevant professional experience.

At least two years of experience managing clinical research site operations or leading a clinical research team.

Experience overseeing clinical trial execution, staff performance, regulatory compliance, and operational deliverables.

Bilingual English/Spanish proficiency is preferred.

Required Skills and Competencies

Proficiency with Microsoft Office applications, email, electronic health records, web-based systems, and other standard business software.

Strong organizational, time management, project management, and problem-solving abilities.

Excellent written and verbal communication skills, including the ability to communicate effectively with investigators, staff, participants, and external stakeholders.

Strong interpersonal, leadership, and listening skills, with the ability to work independently and collaboratively.

Ability to manage multiple studies, deadlines, and competing priorities in a changing environment.

Professionalism, accountability, initiative, and a strong commitment to ethical conduct and quality.

Ability to work with minimal supervision, recognize operational challenges, and implement practical solutions.

Ability to maintain confidentiality when handling sensitive participant, medical, and personnel information in accordance with HIPAA and applicable privacy requirements.