Research Operations Manager - Ft. Lauderdale (Full Time, Days

Research Operations Manager - Ft. Lauderdale (Full Time, Days) (301497)

The Operations Manager Clinical Trials Office will independently oversee clinical study operations in the oncology department from activation to close‑out. The role ensures the planning, execution, and completion of clinical trial activities are performed in accordance with applicable Nicklaus Children's SOPs, hospital policies, and regulatory guidelines. The primary focus will be the Phase 1 unit in pediatric oncology, but the manager will be responsible for all study activity in the oncology department.

The manager will lead frontline clinical trials staff, ensuring workflows remain efficient, staff performance aligns with established standards of excellence, and Good Clinical Practice (GCP) is met. Responsibilities include expert guidance, training, management of research staff, and cultivating a compliant, ethical research culture.

• Manage a dynamic team of clinical research coordinators, ensuring efficient workload distribution and high‑quality research operations.
• Analyze feasibility of potential clinical studies and directly oversee initiation, management, and execution of trials.
• Collaborate with the CTO director, stakeholders, and support the research mission of NCHS. Execute goals and objectives and support strategic plans.
• Apply strategic and innovative thinking to enhance development and implementation of an early‑phase research program, ensuring alignment with new or changing research regulations.
• Maintain accurate, up‑to‑date CTMS entries, reviewing study status, participant enrollment, and study personnel.
• Identify barriers to quality services, compliance, or ineffective processes.
• Monitor recruitment targets and develop recruitment options within the EHR and physician networks.
• Relay information to departmental staff and serve as an open forum for staff feedback and general discussion.
• Work with physicians and other researchers to provide required training; ensure all training is current.
• Work with investigators and study teams to meet targets and milestones, ensuring timely data entry, adverse event reporting, and other protocol requirements.
• Collaborate closely with hospital compliance on conflict‑of‑interest issues, PHI, and other compliance areas.

• Bachelor's Degree or equivalent related research work experience
• 4‑7 years of extensive clinical research experience in an academic hospital, university, CRO, or pharmaceutical/medical device company setting
• 2‑4 years of clinical research leadership and management experience as a supervisor or manager

• Master’s Degree preferred.
• Expert knowledge of a clinical trial management system and e‑Regulatory system.
• Ability to work with physicians, sponsors, and other research staff for protocol development and ensure compliance.
• Proven ability to formulate, develop, and recommend a broad range of research‑related compliance policies for a hospital or institutional setting.
• Excellent verbal and written communication skills.
• Logical thinking to interpret regulations and research‑related issues; solve a broad range of problems.
• Analytical skills to provide productivity assessments.
• Ability to remain calm and adapt under stressful conditions.
• Able to lead and mentor supervisors, managers, and directors.
• Ability to oversee creation of standard operating procedures and ensure proper execution.