Certified Medical Assistant-Clinical Research Coordinator

Benefits

Qualifications

• •Phlebotomy certification or Medical Assistant certification - one is required
• •Associate’s degree in healthcare or a related field, or equivalent relevant experience
• •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
• •5 more items(s)

Responsibilities

• •SUMMARY: The Clinical Research Coordinator I 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
• •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
• •20 more items(s)