Summary

Leads the day-to-day coordination activities of the clinical research study in Pediatric Neurology. Primary responsibilities include patient enrollment, screening, monitoring of research participants, and reporting to the clinical research sponsor. Responsible for ensuring accurate data collection, documentation, organization, and safety of study volunteers. Provides exceptional patient/customer experiences by coordinating care, visits, and study requirements with patients and their families.

The position will coordinate study activities as described above in Pediatric Neurology. It requires advanced knowledge of research coordination and the ability to manage complex clinical trials. The individual should be able to operate independently with minimal guidance. The position may also assist, guide, or provide support to lower-level team members.

The position is primarily on-site Monday through Friday, from 8:00 AM to 5:00 PM, in alignment with clinic hours. There is flexibility to adjust the schedule between 7:00 AM and 6:00 PM based on individual needs. Additionally, occasional weekend work may be required, depending on study demands and patient availability. 

Job Duties

• Manages patient enrollment efforts, identifies recruitment strategies, and performs patient screening and interviews to enroll participants in Pediatric Neurology studies.
• Explains study processes and procedures to educate participants and their families.
• Collects and records study data related to procedures such as, but not limited to, catheterizations, cardiac measurements, and other relevant tests and measurements.
• Responsible for electronic case reporting in accordance with FDA regulations and clinical trial requirements.
• Collects patient information, processes documents, and enters data into a database.
• Performs research-related procedures as required, such as venipuncture (blood draws), EKGs/ECGs, and obtaining vital signs from study participants.
• Corresponds with patients throughout the study.
• Schedules research participants for tests and procedures, including laboratory tests, X-rays, and other study-specific visits per the research protocol.
• Interacts with sponsors and/or coordinating sites as needed to facilitate protocol activities and maintain current study documentation.
• Collects, processes, and stores or ships blood and biological specimens as outlined in study protocols and associated lab or procedural manuals, in accordance with IATA guidelines.
• Maintains records and regulatory documents for the research study.
• Retrieves and submits test results to the appropriate parties.
• Manages supply orders and equipment in coordination with the study sponsor as necessary.
• Reviews protocol documents, including abstracts, text, and informed consent forms, for relevant information.
• Prepares documentation necessary to obtain initial and continued approval for the research protocol.
• Collaborates with physicians, mid-level practitioners, research nurses, and data managers to document patient care.
• Conducts subject education related to the research study as required, within the scope of practice.
• Submits serious adverse event reports and follows up as needed.
• Evaluates and analyzes clinical research data as appropriate.
• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Bachelor's degree in a basic science or healthcare-related field. Four years of related experience may substitute for the degree requirement.
• Five years of relevant experience.
• ACRP Certified Clinical Research Coordinator or SOCRA Certified Clinical Research Professional certification.
• Experience with EPIC.
• Experience in therapeutic clinical research studies.
• Knowledge of FDA Good Clinical Practices (GCP).