Clinical Research Manager Opportunity in San Marcos, TX (78666)

Position Summary:

We are seeking a Clinical Research Manager with expertise in overseeing multi-center studies/clinical trials. The ideal candidate will possess strong interpersonal and project management skills, capable of engaging with stakeholders at all levels of clinical research, from research assistants and Principal Investigators to patients enrolled in the study. The role involves effectively leading a large research team, offering guidance, and hands-on assistance when necessary. The incumbent will ensure strict adherence to all relevant regulations, Good Clinical Practices (GCP), and industry standards governing research involving human subjects, fostering an environment of integrity and quality in clinical studies.

Qualifications and Education Requirements:

• Bachelor’s Degree or equivalent, along with relevant experience.
• Preferred but not necessary: Ophthalmic Experience.
• 5 years of experience in clinical research operations management.
• Excellent knowledge of ICH GCP guidelines.
• Preferred: Background in clinical research and people management, with familiarity in management best practices.

Preferred Skills/Experience:

• Demonstrated proficiency in clinical research and staff management.
• Ability to train and develop staff.
• Exceptional organizational and planning skills, focusing on key priorities.
• Strong work ethic, with a willingness to support the team when needed.
• Team player with the capacity to receive and provide constructive feedback.
• Motivational skills to inspire a high-functioning team.
• Excellent verbal and written communication skills.
• Strong supervisory and leadership abilities.
• Preferred: CCRP certification.

Role and Responsibilities:

• Staff management, including hiring, training, and coaching/mentoring.
• Mentorship and guidance on study processes and requirements.
• Oversight of site workflow for optimal customer service.
• Management of study processes, including timely review of reports and deliverables.
• Oversight of site audits and inspections.
• Identification and resolution of site performance and compliance issues.
• Collaboration with QA team and Regulatory Manager for site readiness.
• In-depth understanding of study protocols, contributing to team knowledge.
• Ensure site meets screening, randomization, and completion/retention goals.
• Quality assurance process adherence for high-quality data collection.
• Foster a positive team culture and meet cultural goals.
• Step into coordinator/research assistant role when needed.

Financial Administrative:

• Maintain a tracking system for study-related costs.
• Generate monthly reports for clinical trials, financial reports, and patient visit distribution.
• Collaborate with finance/accounting department for study costs and department budget.
• Staff management, including hiring, training, and coaching/mentoring.
• Mentorship and guidance on study processes and requirements.
• Oversight of site workflow for optimal customer service.
• Management of study processes, including timely review of reports and deliverables.
• Oversight of site audits and inspections.
• Identification and resolution of site performance and compliance issues.
• Collaboration with QA team and Regulatory Manager for site readiness.
• In-depth understanding of study protocols, contributing to team knowledge.
• Ensure site meets screening, randomization, and completion/retention goals.
• Quality assurance process adherence for high-quality data collection.
• Foster a positive team culture and meet cultural goals.
• Step into coordinator/research assistant role when needed.

Additional Details:

• Position: Clinical Research Manager
• Location: San Marcos, TX (78666)
• Hours: Monday-Friday; Onsite 5 Days a week; Normal Business Hours
• Employment: Direct Hire
• Salary: $80,000-$100,000 Annual Salary (Dependent on background and years of experience)