Description

Job Summary

The Operations Manager Clinical Trials Office will independently oversee clinical study operations in the oncology department from activation to close-out. 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 of this role will be in the Phase 1 unit in pediatric oncology but will be responsible for all study activity in the oncology department. Responsible for the frontline management of the clinical trials staff, ensuring that workflows remain efficient and that staff performance aligns with established standards of excellence and Good Clinical Practice (GCP). Requires extensive expertise in clinical research operations, strong collaboration with cross-functional teams and a commitment to ensuring compliance that drives successful execution of clinical trials for our pediatric patients. Additionally, this role delivers expert guidance, training, and management to the research staff, cultivating a culture of ethical, humane, and compliant research.

Job Specific Duties

• Manage a dynamic team of clinical research coordinators, ensuring efficient workload distribution and high-quality research operations.
• Analyze the feasibility of potential clinical studies, ensuring that new studies are properly initiated, and directly overseeing the management and execution of trials.
• Collaborates with the CTO director and stakeholders and supports the research mission of NCHS. Execute the goals and objectives, and support the strategic plans.
• Strategic and innovative thinking to enhance the effective and efficient development and implementation of an early phase research program. Ensuring alignment with new or changing research regulations.
• Ensures CTMS is accurate, up-to-date, and reviewed in accordance with management plans, specifically the study status, participant enrollment status, and study personnel are accurate and current.
• Identifies barriers to quality services, compliance, or ineffective processes.
• Responsible for monitoring recruitment targets and developing recruitment options within the EHR and physicians.
• Responsible for relaying information to departmental staff and serving as an open forum for staff feedback and general discussion.
• Works with physicians and other researchers on required training. Ensure all necessary training is provided for NCRI and is current.
• Works with investigators and study teams to help meet targets and milestones, ensures timely and accurate data entry, adverse event reporting and other protocol requirements.
• Works closely with hospital compliance for conflict-of-interest issues, PHI, and other concerning areas of compliance.

Qualifications

Minimum Job Requirements

• Bachelor's Degree or equivalent related research work experience
• 4-7 years of extensive clinical research experience in either an academic hospital engaged in research, university, CRO, or pharmaceutical/medical device company setting
• 2-4 years of clinical research leading and managing a team with experience as a supervisor and/or manager role

Knowledge, Skills, and Abilities

• 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.
• Ability to communicate effectively both verbally and in writing.
• Ability to use logical thinking to interpret regulations and research related issues; solve a broad range of problems.
• Ability to use analytical skills and provide productivity assessments.
• Ability to interpret, adapt, and react calmly under stressful conditions.
• Able to lead and mentor supervisors, managers, and directors.
• Ability to oversee creation of standard operating procedures and procedures are carried out properly

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