Job Description

Lead Clinical Research Coordinator

The Lead Clinical Research Coordinator plays a critical role in supporting the execution of clinical research studies by coordinating and performing remote clinical activities in compliance with study protocols, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP). This role is responsible for performing a variety of clinical procedures to collect, record, report, and interpret patient data for individuals enrolled in or seeking enrollment in clinical studies.

Responsibilities and Duties

• Adhere to SOPs and Manual of Procedures when conducting all study-related activities to ensure compliance and consistency. This includes maintaining a working knowledge of study-specific software applications and equipment.
• Collaborate with the research team and study sites to identify, recruit, and virtually enroll eligible patients for clinical trials.
• Collect, maintain, and securely store all relevant data associated with clinical research trials in accordance with regulatory and organizational standards.
• Educate potential participants about clinical research trials, including study requirements, and manage the informed consent process through virtual interactions.
• Assist with participant study compliance by providing guidance and reminders to ensure adherence to protocol requirements.
• Conduct follow-up activities for clinical trials while maintaining adherence to Good Clinical Practice (GCP) guidelines.
• Ensure patient safety by monitoring participants, reporting adverse events promptly, and ensuring compliance with IRB-approved protocols.
• Support the research participant call center as assigned, handling inquiries and providing assistance.
• Maintain professionalism in all interactions with research participants to foster trust and engagement.
• Assist with study equipment management and reporting, ensuring proper tracking, functionality, and documentation.
• Communicate effectively with MCRA clinical affairs staff and clients, providing updates and support under the guidance of senior MCRA staff as needed.
• Perform additional duties and projects as assigned to support the success of clinical research operations.

Required Knowledge, Skills, and Experience

• Education: Bachelor's degree required (preferably in a life sciences or healthcare-related field)
• Experience: Minimum of three years of experience as a Clinical Coordinator or in a comparable clinical research role
• Strong attention to detail
• Excellent verbal and written communication skills

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