Clinical Research Coordinator

Description

• Coordinate and attend pre-study site visits, site initiation visits, and monitor visits.
• Manage study medication inventory and patient compliance accurately.
• Record data legibly and enter it in real-time on paper or electronic sources.
• Identify and report adverse events and serious adverse events promptly.
• Work with recruitment teams to actively recruit subjects.
• Review laboratory results and test outcomes for completeness and alert values.
• Attend Investigator meetings as required.
• Ensure training and study requirements are met before trial conduct.
• Train others and perform basic clinical procedures such as blood draws and ECGs.
• Contribute to recruitment planning and material development.
• Resolve data management queries within sponsor-provided timelines.
• Assist with regulatory documentation and source document creation.
• Conduct visit procedures in alignment with protocol guidelines.
• Review and assess protocol amendments for clarity and feasibility.
• Maintain adherence to FDA regulations and ICH guidelines throughout the clinical trial process.
• Interact professionally with patients, sponsor representatives, investigators, and management.
• Discuss study medication and required procedures with the Investigator and site staff.
• Prioritize activities according to protocol timelines.
• Foster effective relationships with study participants and research personnel.
• Ensure adequate supply availability for protocol initiation.

Requirements

• Strong understanding of institutional SOPs.
• Critical thinking and problem-solving abilities.
• Familiarity with federal regulations and good clinical practices (GCP).
• Bachelor’s Degree preferred or equivalent combination of education and experience.
• Professional writing and communication skills.
• Strong organizational and leadership capabilities.
• Prescreen study candidates and obtain informed consent.
• Effective communication and teamwork skills.
• Proficiency with clinical trial databases, IVR systems, and EDC.
• Excellent knowledge of medical and research terminology.
• Attention to detail.
• Ability to work independently in a fast-paced environment.
• Minimum of 3 years of prior Clinical Research Coordinator experience required.
• Recent phlebotomy experience required.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance