Clinical Research Coordinator I

Job Summary

We are seeking a dedicated Clinical Research Coordinator to support the coordination and execution of clinical research studies within a healthcare setting. This role ensures clinical trials are conducted in compliance with study protocols, regulatory requirements, and institutional policies while protecting participant safety and data integrity.

Key Responsibilities

• Conduct screening visits, collect medical history and basic vitals, and assist with the informed consent process and participant enrollment.
• Carefully coordinate and schedule study visits, procedures, and follow-up activities; communicate with participants to provide education, answer questions, and support study adherence.
• Collect, record, and maintain accurate clinical research data, source documentation, and medical history documentation. Perform data entry and scan, upload, and file organized study records.
• Maintain safety and compliance by monitoring study progress, asking about and reporting any Adverse Events (AEs) or Serious Adverse Events (SAEs) during patient questionnaires, and adhering to site Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) guidelines.
• Support laboratory support by drawing, processing, and shipping laboratory specimens (including the handling of dangerous goods) in accordance with regulations, if qualified.
• Collaborate with fast-paced clinical teams to apply critical thinking skills to support efficient study operations, problem resolution, and transparent communication.

Qualifications & Requirements

• Education: High school diploma or equivalent required; an associate's degree or higher in a health-related field preferred.
• Experience: Basic knowledge of clinical research strongly preferred. Direct patient care experience required (Medical Assistants, Research Assistants, or Lab Coordinators thrive well in this position).
• Core Skills: Strong medical terminology knowledge, excellent organizational and time-management skills, high attention to detail, and the ability to communicate clearly and professionally with diverse populations.
• Technical Knowledge: Familiarity with clinical research protocols, electronic data capture systems, clinical trial management software, and Microsoft Office (Excel, Word, PowerPoint).
• Regulations: Knowledge of GCP, HIPAA, ALCOA principles, FDA regulations, and IATA guidelines strongly preferred.

Qualifications

• Medical Assistant (MA) certification preferred.
• Current CPR/BLS certification preferred.
• Certification as a Clinical Research Coordinator (e.g., CCRC) or a willingness to obtain certification preferred.

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Note: Medical Assistants with strong direct patient care experience, as well as candidates with prior Research Assistant or lab coordination backgrounds, are strongly encouraged to apply.

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About Kelly

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