Senior CRA II - Global Clinical Research Impact

Worldwide Clinical Trials; United States; À distance; USD 70 000 - 120 000; Plein temps

Résumé du poste

Worldwide Clinical Trials is seeking a Clinical Research Associate to support site qualification, initiation, monitoring, and close-out visits across global studies. You will ensure data quality, safety reporting, and regulatory compliance while collaborating with sites and internal teams.

The role requires strong communication, planning, and problem-solving skills, plus a solid foundation in clinical research principles and regulatory guidelines.

Qualifications

• Excellent oral and written communication skills.
• Strong planning and organizational abilities.
• Demonstrated problem-solving and initiative.
• Ability to work in a structured, process-driven environment.
• Solid understanding of clinical research principles and regulatory requirements.

Responsabilités

• Responsible for site qualification, initiation, interim monitoring, site management and close-out visits per GCP and SOPs.
• Ensure data quality and timely reporting of safety events by site personnel.
• Perform feasibility studies for potential sites and coordinate regulatory submissions.
• Support study documentation: IRB/IEC approvals, informed consent, TMF updates.
• Coordinate shipment of study materials and maintain communication with sites.
• Provide training and input on protocol/designs and monitoring plans.
• Manage data queries and ensure site compliance with IP receipt and destruction.

Connaissances

Communication skills

Planning & organization

Interpersonal skills

Problem solving

Organized and methodical

Clinical research understanding

FDA/EU regulations knowledge

Microsoft Office

IxRS & EDC proficiency

Formation

MD or PharmD or equivalent

Four-year science degree with clinical research experience

Nursing or life sciences degree with CRA experience

Outils

Microsoft Office

IxRS

EDC systems

Description du poste

Worldwide Clinical Trials is seeking a Clinical Research Associate to support site qualification, initiation, monitoring, and close-out visits across global studies. You will ensure data quality, safety reporting, and regulatory compliance while collaborating with sites and internal teams.

The role requires strong communication, planning, and problem-solving skills, plus a solid foundation in clinical research principles and regulatory guidelines.