Medical Assistant-Clinical Research Coordinator

Medical Assistant-Clinical Research Coordinator

The Clinical Research Coordinator (Medical Assistant) supports the conduct of clinical trials by coordinating study visits, managing data collection, and ensuring compliance with protocols and regulatory guidelines. This role involves direct interaction with participants and plays a key part in maintaining study integrity and quality.

Essential Duties and Responsibilities:

• Communicate clearly and professionally with study participants regarding study objectives and ongoing instructions.
• Administer questionnaires and monitor participant compliance with study protocols.
• Respond to participant needs promptly and appropriately.
• Collect and document patient medical history and health conditions.
• Obtain and document informed consent from study participants.
• Maintain accurate records of study drug dispensation and accountability.
• Coordinate with laboratories to ensure timely testing and reporting.
• Collect and assess information on concomitant medications.
• Review and evaluate medical records for protocol compliance.
• Perform and document assessments for adverse events (AEs) and serious adverse events (SAEs).
• Conduct clinical procedures including EKGs, vital signs, nasal swabs, and other protocol-specific tasks.
• Review and evaluate clinical laboratory reports.
• Maintain up-to-date regulatory files for the research site.
• Verify the accuracy and completeness of collected data.
• Monitor and document temperatures for investigational product (IP) storage.
• Support recruitment and engagement of study participants as needed.
• Develop electronic source (e-source) documents in accordance with study protocols.
• Manage study startup documentation, training, and timelines for assigned protocols.
• Ensure all protocol requirements and deadlines are met consistently.
• Adhere to all company policies, procedures, and code of conduct.
• Maintain strict confidentiality and compliance with regulatory standards.

Education and Experience:

• At least 1 year of experience with phlebotomy (certification needed) and EKG procedures, or a Medical Assistant certification
• Associate's degree in healthcare or a related field, or equivalent relevant experience
• 2+ years of experience in a healthcare setting
• 2+ years of experience with FDA regulations and Good Clinical Practice (GCP)
• Demonstrated analytical reasoning skills
• Exceptional attention to detail and strong organizational skills
• Excellent verbal and written communication abilities
• Proven customer service skills with both internal and external stakeholders
• Ability to effectively manage multiple priorities in a fast-paced environment