Department:

Clinical Research Reports To:

Chief Operating Officer (COO)

FLSA Status:

Exempt On-Site Position Summary Retina Associates of Cleveland, Inc. (RACI) is seeking an experienced and visionary Research Director to lead and expand its clinical research program across multiple practice locations. Reporting directly to the Chief Operating Officer, the Research Director is responsible for the strategic, operational, regulatory, financial, and personnel oversight of all clinical research activities. The Research Director serves as the senior leader of the research division and partners closely with physician investigators, executive leadership, pharmaceutical company sponsors, CROs, and research staff to advance innovative retinal therapies, enhance patient access to clinical trials, and position RACI as a premier retina research organization.

Supervisory Responsibilities:

The Research Director directly supervises clinical research coordinators, research assistants, and research technicians. He/she will also be responsible for expanding the team as applicable.

Essential Duties and Responsibilities:

Develop and execute a multi-year strategic plan for RACI's research program. Lead all aspects of clinical research operations including study startup, enrollment, conduct, monitoring, and closeout. Identify and secure new clinical trial opportunities with sponsors, CROs, and industry partners. Serve as the primary contact for sponsor relationships and site development initiatives. Oversee regulatory compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and IRB standards. Ensure audit readiness and lead responses to sponsor, regulatory, and quality audits. Establish departmental policies, SOPs, workflows, and quality systems. Partner with physician investigators to identify and evaluate new research opportunities. Develop and oversee patient recruitment and retention strategies. Prepare and manage annual departmental budgets. Review and negotiate study budgets, contracts, and resource allocations. Monitor research revenue, profitability, staffing needs, and operational performance. Recruit, mentor, develop, and evaluate research personnel. Develop departmental KPIs and regularly report performance metrics to executive leadership. Represent RACI at investigator meetings, industry conferences, and professional organizations.

Qualifications Required:

Bachelor's degree in life sciences, healthcare administration, nursing, public health, or related field. Minimum 10 years of clinical research experience. Minimum 5 years of leadership experience overseeing clinical research operations. Thorough knowledge of FDA regulations, ICH-GCP, HIPAA, and clinical research compliance. Experience managing sponsor and CRO relationships. Strong financial, operational, and personnel management skills.

Preferred:

Master's degree (MBA, MPH, MHA, MSN, or related field). CCRP, CCRC, ACRP-CP, or equivalent certification. Ophthalmology, retina, or specialty physician practice research experience. Multi-site research management experience.

Knowledge, Skills, and Abilities:

Strategic leadership and organizational development Clinical trial operations and regulatory oversight Budgeting, forecasting, and contract negotiation Team leadership and talent development Business development and relationship management Performance improvement and data analysis Excellent written, verbal, and presentation skills Strong project management and problem-solving abilities

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