Clinical Research Site Director - 248142 - Orlando - Medix™

    Medix™
    Medix™ Orlando

    2 hours ago

    Engineering / Architecture
    Description

    We are hiring for a Clinical Research Site Director in the Orlando area. MUST have experience as a director at a site-level. Open to relocation candidates with the right experience.

    *Relocation assistance available*

    Clinical Site Director (Onsite Role)

    The Clinical Site Director is responsible for leading day-to-day operations at a clinical research center. This onsite position provides hands-on oversight to ensure that all clinical research activities are executed in alignment with ICH guidelines, GCP, FDA regulations, and internal policies. The role requires strong leadership, consistent presence at the site, and active management of research staff.

    Key Responsibilities

    Operational Leadership & Site Performance

    • Provide comprehensive onsite leadership to drive site performance, operational efficiency, participant safety, and adherence to regulatory and protocol requirements.
    • Oversee the daily functioning of the research site, ensuring staff coverage, quality standards, and smooth execution of study activities.

    Cross-Functional Collaboration

    • Partner with internal teams across Business Development, Patient Recruitment, Finance, Budgets & Contracts, and Quality to align on expectations, maintain study timelines, meet enrollment goals, and deliver high-quality data to sponsors.

    Study Oversight & Data Quality

    • Review performance dashboards and clinical trial systems to monitor patient flow, visit schedules, staff activity, and data updates.
    • Ensure timely and accurate completion of all required study activities, documentation, and communications.

    Resource & Staff Management

    • Lead allocation of site resources, monitor study team performance, and identify operational or quality risks.
    • Manage, mentor, and evaluate research staff including coordinators and support personnel.
    • Oversee interviewing, hiring, performance evaluations, coaching, training, disciplinary actions, and (as needed) terminations.
    • Manage schedule approvals, payroll oversight, new hire onboarding, and ongoing staff development.

    Training & Compliance

    • Facilitate initial and ongoing training on protocol requirements, CRF completion, SOPs, and operational guidelines.
    • Ensure strict adherence to SOPs, GCP, FDA regulations, and internal quality standards.
    • Identify compliance issues or process gaps and support the development and execution of corrective action plans.

    Investigator & Sponsor Support

    • Collaborate closely with investigators to uphold participant safety and meet protocol expectations.
    • Provide proactive risk mitigation strategies and support sponsor expectations throughout the study lifecycle.

    Administrative & Leadership Duties

    • Participate in leadership, site, and sponsor meetings as needed.
    • Perform additional duties as assigned to support the success of the research site.

    Skills, Knowledge & Expertise

    Minimum Qualifications

    • Bachelor's degree and 5+ years of clinical research experience; an equivalent combination of education and experience may be considered.
    • At least 2 years of supervisory or management experience, ideally within a clinical research site setting.
    • Bilingual (English/Spanish) proficiency is preferred.

    Required Skills

    • Strong organizational, time-management, problem-solving, and project management skills.
    • Excellent written and verbal communication abilities.
    • Strong interpersonal skills with the ability to work effectively with colleagues, participants, investigators, and external partners.
    • Ability to manage multiple priorities and adapt to shifting demands.
    • Professional demeanor with a high level of integrity, dependability, and initiative.
    • Ability to work independently, identify operational issues, and implement solutions.
    • Strict adherence to confidentiality standards, including HIPAA requirements.
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