Clinical Operations Specialist (225-816)

The Clinical Operations Specialist plays a crucial role in ensuring the effective and efficient execution of clinical trials and healthcare management within a healthcare organization or pharmaceutical company. This position acts as a bridge between the clinical research team and the operational aspects of clinical projects, coordinating various activities and ensuring compliance with regulatory requirements. The specialist is responsible for planning, executing, and managing clinical-related projects while maintaining a focus on timelines, budget, and quality standards. The role demands a strong understanding of clinical trial methodologies, excellent organizational skills, and the ability to communicate effectively with diverse teams. A successful Clinical Operations Specialist will contribute significantly to the smooth progression of clinical studies, impacting patient care and advancing medical research.

Responsibilities

• Coordinate and oversee clinical trials, ensuring they adhere to protocol and regulations.
• Manage clinical project timelines to meet specified deadlines and objectives.
• Develop and maintain standard operating procedures for clinical operations.
• Ensure compliance with local, state, and federal research regulations.
• Provide support in the development and submission of regulatory documents.
• Collaborate with cross-functional teams to align clinical and operational activities.
• Monitor clinical data quality and integrity throughout the study phases.
• Conduct site visits to assess protocol compliance and provide guidance.
• Facilitate communication among investigators, sponsors, and clinical staff.
• Handle project budget tracking, including financial forecasts and reporting.
• Perform risk management to identify and mitigate potential project challenges.
• Assist in training clinical site staff on trial protocols and procedures.

Requirements

• Bachelor's degree in life sciences, healthcare, or a related field required.
• A minimum of 3 years of experience in clinical trial operations is essential.
• Strong knowledge of Good Clinical Practice (GCP) and other relevant guidelines.
• Proficient in the use of clinical trial management systems and software tools.
• Excellent organizational and time-management skills with attention to detail.
• Ability to work effectively in a team-oriented environment and independently.
• Strong communication skills, both written and oral, for diverse audiences.