Clinical Research Operations Manager
3 weeks ago
Position Overview:
The Clinical Research Site Manager will play a pivotal role in overseeing the operations of clinical research activities. This position is essential for ensuring that all clinical trials are conducted in compliance with regulatory standards and organizational protocols.
Key Responsibilities:
- Lead and manage all clinical research personnel, including investigators, coordinators, and research assistants, to guarantee high performance across all studies.
- Ensure comprehensive understanding of study protocols among all team members through thorough training and review sessions prior to study initiation.
- Facilitate effective communication and collaboration within the research team to ensure clarity of roles and responsibilities.
- Guide the research team in identifying and enrolling qualified subjects in a timely manner, adhering to the sponsor's enrollment criteria.
- Collaborate with the Principal Investigator to ensure that all studies are executed in accordance with FDA regulations and Good Clinical Practice (GCP) guidelines.
- Monitor site performance metrics and ensure that revenue targets are met while managing the site budget effectively.
- Oversee the accuracy and completeness of case report forms and ensure compliance with all regulatory requirements.
- Implement and uphold standard operating procedures (SOPs) and best practices to maintain high-quality research standards.
- Prepare for and manage audits, addressing any identified deficiencies promptly and effectively.
- Develop and mentor the site team, fostering a culture of accountability and professional growth.
Qualifications:
- A minimum of 5-7 years of clinical experience in a healthcare setting, with at least three years in a management role preferred.
- Proven track record of leading and motivating teams in a clinical research environment.
- Strong understanding of the clinical research process and regulatory requirements.
- Exceptional leadership and supervisory skills, with the ability to manage multiple projects simultaneously.
- Excellent communication and interpersonal skills, with a focus on teamwork and collaboration.
- Ability to adapt to various therapeutic areas and manage dynamic project demands.
This role is crucial for the successful execution of clinical research initiatives and will contribute significantly to the growth and development of the organization.
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