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Clinical Research Operations Manager
2 months ago
Position Overview:
ZRG Partners, LLC is seeking a dedicated Clinical Research Site Manager who will play a pivotal role in overseeing clinical research activities. This position is crucial for ensuring the smooth operation of research studies and managing the clinical staff effectively.
Key Responsibilities:
- Lead and manage all clinical research personnel, including investigators, coordinators, and research assistants, to ensure high performance across all studies.
- Ensure that all team members possess a comprehensive understanding of study protocols through thorough training and review prior to study initiation.
- Collaborate with the research team to review all study components before the start date, ensuring clarity in roles and responsibilities.
- Guide the research team during participant screening to ensure timely identification and enrollment of qualified subjects.
- Develop and implement effective enrollment strategies in alignment with sponsor protocols and timelines.
- In partnership with the Principal Investigator, oversee the execution of studies in compliance with FDA regulations, Good Clinical Practice (GCP) guidelines, and organizational standard operating procedures (SOPs).
- Manage site financials, including budget oversight and revenue target achievement.
- Ensure all case report forms are completed accurately and maintained in accordance with regulatory requirements.
- Facilitate laboratory test compliance and ensure all procedures are followed according to established protocols.
- Maintain regular communication with sponsors, providing accurate and complete information as required.
- Address any deficiencies identified during audits and implement necessary corrective actions.
- Responsible for team development, including recruitment, training, and performance management.
- Foster a culture of accountability and continuous improvement within the team.
Qualifications:
- A minimum of 5-7 years of clinical experience in a healthcare setting, with at least three years in site management preferred.
- Proven ability to lead and motivate teams effectively.
- In-depth knowledge of the clinical research process and regulatory requirements.
- Strong leadership skills with the ability to supervise and guide teams.
- Self-motivated with excellent initiative and the ability to manage multiple projects simultaneously.
- Exceptional communication and interpersonal skills.
- Familiarity with Universal Precautions and standard operating procedures.
This role is an excellent opportunity for a skilled professional looking to make a significant impact in the field of clinical research management.
