Associate Director of Operations - Center for Interventional Cardiovascular Research and Clinical Trials

The Associate Director of Operations supports and oversees the daily operational, administrative, and research activities of the department. This role provides leadership across staff supervision, retention, budgetary oversight, materials management, data management, and regulatory compliance to ensure the successful execution of clinical research programs.

In collaboration with the Director and faculty leadership, the Associate Director advances the Center’s strategic growth through business development initiatives and the innovative use of technology, data analytics, and artificial intelligence (AI). The role is responsible for developing, implementing, and continuously improving departmental policies, procedures, and standard operating procedures (SOPs) to promote operational excellence, compliance, and scalability.

Operational & Administrative Leadership

• Lead all administrative operations, managing a multidisciplinary team supporting clinical trials, registries, and translational research.
• Provide day-to-day supervision of the Clinical Trial Management Team, Administration Team, and Catheterization Laboratory Research Team.
• Assist the Director in daily departmental operations and provide professional and administrative guidance to staff.
• Evaluate operational performance and identify opportunities for improvement; advise and inform the Director of administrative issues, needs, and risks.
• Plan, organize, and implement services to meet departmental goals and objectives.
• Develop, implement, and refine departmental policies, procedures, and SOPs to ensure efficiency, quality, and regulatory compliance.

Human Resources & Staff Development

• Oversee hiring, supervision, mentoring, evaluation, and retention of administrative and research staff.
• Foster a culture of accountability, inclusivity, collaboration, and professional development.
• Participate in interviewing and recommending candidates; assist with onboarding, orientation, mentoring, training, and probationary and annual evaluations.
• Recommend recognition, disciplinary actions, and termination when necessary.
• Maintain staff competencies through ongoing training and professional development initiatives.

Regulatory Compliance & Quality Oversight

• Ensure compliance with IRB, FDA, GCP, ICH, and institutional policies and standards.
• Review and assist with regulatory submissions, including IRB/IEC packages and continuing reviews.
• Conduct regular reviews of the Trial Master File (TMF) to ensure inspection readiness.
• Review monitoring visit reports and collaborate with monitors to address data quality, compliance trends, and site issues.

Clinical Research Management

• Manage and coordinate assigned clinical research studies to ensure adherence to protocols, SOPs, and regulatory requirements.
• Coordinate clinical trial schedules, staff assignments, and subject management activities.
• Oversee subject enrollment, tracking, and completion of required regulatory documentation.
• Support study design, including review and/or development of protocols, informed consent forms (ICFs), and related study documents.
• Contribute to the development of Case Report Forms (CRFs).
• Plan and conduct site evaluations, initiations, and routine monitoring visits; maintain strong relationships with clinical sites.
• Plan, organize, and present at investigator meetings.
• Serve as the primary point of contact for CROs and clinical vendors; provide study status updates, enrollment metrics, safety trends, and recommendations.

Budgeting, Finance & Vendor Oversight

• Assist in the preparation, planning, and management of departmental and study budgets.
• Perform financial reconciliations, cost variance analyses, and budget justifications.
• Recommend and implement cost-effective operational strategies.
• Contribute to the development and negotiation of study budgets and contracts; ensure effectiveness of site budget and contract processes.
• Provide oversight and accountability for all third-party vendors.

Strategic Growth, Business Development & Innovation

• Drive cross-departmental collaboration to enhance research delivery, scalability, and impact.
• Collaborate with faculty and scientific leadership to identify emerging research opportunities and partnerships.
• Support investigators in preparing high-quality research submissions, including budgets, biosketches, letters of support, and compliance documentation.
• Manage the full proposal lifecycle, including feasibility assessments, RFP responses, bid defenses, and submissions.
• Leverage advanced data analytics, digital platforms, and AI-driven tools to streamline operations and improve decision-making.
• Champion predictive analytics, machine learning, and decision-support systems to optimize research performance and forecasting.

Other Duties

• Perform other related duties as assigned.

• Bachelor's degree in public health/administration or business or a related field or equivalent education and experience; Masters (MPA, MPH, MBA or related) is preferred.
•  5 years of experience in a professional business environment, with health related and project management experience preferred. Supervisory experience is a plus; 1 year in CRO, Pharma, Biotech or ARO preferred