CLINICAL RESEARCH COORDINATOR

Job Summary

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and conduct of clinical research studies at the assigned StrideCare site. Working under the supervision of the Principal Investigator (PI) and in collaboration with Clinical Operations leadership, the CRC ensures compliance with study protocols, FDA regulations, ICH Good Clinical Practice (GCP) guidelines, sponsor requirements, and organizational standards while supporting participant safety and study success.

Essential Duties / Responsibilities

• Screens patients for study enrollment and eligibility.
• Conducts and documents patient consent activities.
• Collaborates with Clinical Operations leadership.
• Coordinates patient follow-up visits and study schedules.
• Documents study activities in source documents and clinic charts.
• Enters data into EDC systems and resolves study queries.
• Obtains vital signs and ECGs per protocol requirements.
• Performs basic laboratory procedures including specimen collection, processing, storage, shipment, and accountability.
• Requests and tracks medical records.
• Maintains study logs, regulatory files, and chart documentation.
• Maintains and orders study-specific supplies.
• Schedules study participants and conducts appointment reminders.
• Builds and updates source documentation as needed.
• Coordinates monitoring visits and resolves findings in a timely manner.
• Ensures study reports and patient results are reviewed by the Investigator.
• Fills out SAE and protocol deviation reports with Sponsors and IRBs as required.
• Documents and reports adverse events and safety concerns.
• Reports non-compliance concerns to appropriate personnel.
• Maintains positive communication with sponsors, monitors, participants, investigators, and team members.
• Adheres to ALCOA-C documentation principles.
• Affixes recruitment, enrollment, and participant tracking activities.
• Completes study start-up activities, training requirements, and regulatory documentation.
• Prepares for and participates in Site Initiation Visits (SIVs) and Investigator Meetings (IMs).
• Affixes setup and maintenance of study-related technology.
• Performs other duties as assigned.

Required Skills / Abilities

• Proficiency with Microsoft Office applications, email, EHR/EMR systems, and web-based applications.
• Accurate data entry and typing proficiency.
• Ability to perform vital signs, ECGs, phlebotomy, and other basic clinical procedures.
• Strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills.
• Strong interpersonal and active listening skills.
• Ability to work independently and collaboratively with investigators, participants, sponsors, and team members.
• Ability to manage multiple priorities and adapt to changing workloads.
• Professional demeanor, dependability, and strong work ethic.
• High degree of integrity and confidentiality.
• Strong problem-solving and critical-thinking abilities.
• Ability to handle sensitive information in compliance with HIPAA requirements.

Education and Experience

• Medical Assistant diploma, LPN/LVN credential, EMT credential, Associate degree, or equivalent combination of education and experience required.
• Minimum one year of clinical research or clinical healthcare experience preferred.
• Experience with phlebotomy, vital signs, ECGs, specimen handling, and clinical documentation preferred.
• Current GCP certification or ability to obtain certification required.
• Bilingual English/Spanish skills are a plus.