Clinical Research Coordinator (31656)

Responsibilities

• Aid in the recruitment of studies and budget evaluation.
• Evaluate and negotiate study protocols.
• Communicate with study sponsors and regulatory bodies.
• Maintain certifications in FDA, GCP, ICH, and related regulations.
• Obtain and maintain patient consent with high ethical standards.
• Lead and manage other research department staff.
• Screen, consent, and conduct medical examinations on patients.
• Communicate with and support patients and their families.
• Utilize EMR and data management systems for EDC, eCRFs, and record-keeping.
• Gain knowledge of relevant software and programs.
• Have a basic understanding of trial design, statistical methods, etc.
• Triage, record, and report adverse events and protocol deviations.
• Collaborate with IRB, study sponsors, and principal investigators.
• Attend necessary meetings and calls.
• Create and maintain departmental Standard Operating Procedures (SOPs), Non-Disclosure Agreements (NDAs), Curriculum Vitae (CVs), certifications, and other documents.
• Evaluate, purchase, and maintain necessary laboratory and medical equipment.
• Maintain HIPAA-compliant communication and confidentiality.
• Monitor and manage study budgets, invoicing, billing, and payments.
• Participate in site visits, Source Investigator Visits (SIVs), monitoring, and other study-related activities.
• Assist with the completion of necessary study close-out steps and documentation.

Qualifications

• Relevant certifications in FDA, GCP, ICH, and federal/state regulations.
• Basic knowledge of trial design, statistical methods, and relevant software.
• Experience with EMR and data management systems.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Excellent organizational and time management skills.
• High ethical standards and commitment to patient care.