Clinical Trial Coordinator

About Us:

Concept Medical is at the forefront of innovative medical device development, dedicated to improving patient outcomes and advancing healthcare solutions. We are seeking a dedicated and detail-oriented Clinical Coordinator to join our dynamic team and support our clinical trial operations.

Job Responsibilities:

• Assist in the creation and management of essential clinical trial documents, including CRFs, Informed Consents, Investigator Brochures, SAE reports, and progress summaries.
• Manage daily clinical trial operations, ensuring the accomplishment of key clinical milestones such as study enrollment.
• Identify, qualify, and initiate clinical sites, ensuring high-quality data collection and conducting quality assurance of data monitoring.
• Participate in the preparation and monitoring of clinical study budgets, and contribute to the development of SOPs.
• Develop and implement enrollment strategies for clinical trial sites and assist in overcoming site performance hurdles.
• Oversee project management performance, including the timely execution of site clinical trial agreements and IRB approvals.
• Assist in hiring departmental personnel and train new clinical trial assistants, project managers, and clinical trial monitors.
• Manage contract employees such as part-time monitors and vendors for clinical trial services.
• Perform other related duties and tasks as required.

Qualifications:

• Bachelor’s degree in life sciences, healthcare, or a related field.
• Minimum of 3-5 years of experience in clinical research or a related area.
• Strong knowledge of FDA regulations, GCP, and ICH guidelines.
• Excellent organizational, communication, and interpersonal skills.
• Ability to manage multiple projects and meet deadlines.
• Proficiency in MS Office Suite and clinical trial management systems (CTMS).