Global Lead CRA: Monitoring & Study Leadership

Worldwide Clinical Trials; Australia; Presencial; AUD 120 000 - 170 000; Tempo integral

Resumo da oferta

Worldwide Clinical Trials is seeking a Lead Clinical Research Associate to manage site qualification, initiation, interim monitoring, and study close-out visits in line with GCPs. You will ensure data quality and timely safety reporting, while mentoring CRAs and coordinating global study activities.

Ideal candidates will have MD/PharmD or related degree with CRA experience, strong regulatory knowledge, and excellent communication, planning, and leadership skills.

Qualificações

• MD or Pharmacist degree with CRA experience.
• Minimum years as CRA depending on educational path.
• Travel willingness and English proficiency required.

Responsabilidades

• Perform feasibility studies for potential sites.
• Conduct pre-study, initiation and interim monitoring visits.
• Lead global studies coordinating CRAs and monitoring activities.
• Develop Clinical Monitoring Plans as requested.
• Review site visit reports and provide feedback.
• Mentor less experienced CRAs and site staff when needed.
• Maintain regulatory documents and TMF materials.
• Ensure protocol adherence and data quality remotely and on-site.
• Train study teams and participate in investigator meetings.
• Coordinate study materials and data query resolution.

Conhecimentos

Communication

Planning & Organization

Interpersonal skills

Initiative & problem solving

Leadership

Process improvement

Clinical research knowledge

Regulatory knowledge

Therapeutic area knowledge

SOPs

MS Office

IxRS/EDC systems

Formação académica

MD or Pharmacist degree

Bachelor degree in life sciences

Nursing or related life science degree

Ferramentas

IxRS

EDC systems

Descrição da oferta de emprego

Worldwide Clinical Trials is seeking a Lead Clinical Research Associate to manage site qualification, initiation, interim monitoring, and study close-out visits in line with GCPs. You will ensure data quality and timely safety reporting, while mentoring CRAs and coordinating global study activities.

Ideal candidates will have MD/PharmD or related degree with CRA experience, strong regulatory knowledge, and excellent communication, planning, and leadership skills.