Senior CRA – Real World Late Phase

Syneos Health Australia Pty Ltd; Australia; Remote; AUD 90,000 - 125,000; Full time

Job summary

Syneos Health Australia Pty Ltd is seeking a Senior Clinical Research Associate to oversee site qualification, initiation, monitoring and close-out visits in Australia. You will ensure regulatory and GCP compliance, perform site visits on-site or remotely, and communicate issues with the project team while developing corrective actions.

The role requires a Bachelor’s or RN, strong communication and interpersonal skills, and the ability to travel up to 75% across sites.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Excellent communication, presentation and interpersonal skills.
• Basic level of critical thinking expected; ability to reasoning through complex data.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP, and protocol compliance.
• Communicates/escalates serious issues to the project team and develops action plans.
• Maintains knowledge of ICH/GCP guidelines and company SOPs; ensures informed consent is obtained and documented.
• Reviews ISF and TMF, supports subject recruitment and retention, and tracks observations and actions.
• Leads, with supervision, clinical monitoring activities and training for junior staff as needed.

Skills

Excellent communication

Presentation skills

Interpersonal skills

Critical thinking

Travel readiness

Education

Bachelor’s degree or Registered Nurse (RN)

Job description

Syneos Health Australia Pty Ltd is seeking a Senior Clinical Research Associate to oversee site qualification, initiation, monitoring and close-out visits in Australia. You will ensure regulatory and GCP compliance, perform site visits on-site or remotely, and communicate issues with the project team while developing corrective actions.

The role requires a Bachelor’s or RN, strong communication and interpersonal skills, and the ability to travel up to 75% across sites.