Phase 1 Clin Res Director/Mgr. of Clinical Ops-Miami, FL

Benefits

Qualifications

• •Bachelor's degree in a scientific or healthcare-related field
• •7-10 years of experience in clinical operations, including 5+ years in a senior leadership role
• •Strong understanding of FDA, ICH, and GCP regulations and guidelines
• •Strong communication, organizational, and leadership skills
• •Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software
• •In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out
• •Experience managing and mentoring a team of clinical operations professionals
• •4 more items(s)

Responsibilities

• •We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies
• •This role demands strict compliance with GCP, ICH guidelines, and company SOPs
• •Core duties include staff management, protocol review, quality assurance, and overall study supervision
• •Lead and mentor the clinical operations team to promote a collaborative and efficient environment
• •Ensure protocol compliance and maintain high-quality standards across studies
• •Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies
• •Oversee human resources functions, including staff evaluations, recruitment, and training
• •Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies
• •Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators
• •Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation
• •Conduct study closeout procedures
• •Perform additional duties as needed to adapt to the evolving needs of CPMI
• •Ensure compliance with all applicable regulations and guidelines, including FDA, ICH, and GCP
• •10 more items(s)