[Hiring] Senior Clinical Research Associate I/II @Syneos Health

Role Description

The Sr CRA I/II (Melbourne/Perth) will perform the following responsibilities:

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely) ensuring compliance with regulatory, ICH-GCP, GPP, and protocol standards.
• Evaluate site performance and staff, providing recommendations and escalating serious issues to the project team.
• Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
• Verify informed consent processes and protect subject/patient confidentiality.
• Assess factors affecting subject/patient safety and clinical data integrity.
• Conduct Source Document Review and verify clinical data accuracy in case report forms (CRFs).
• Apply query resolution techniques and provide guidance to site staff.
• Utilize hardware and software for clinical study data review and capture.
• Perform investigational product (IP) inventory, reconciliation, and compliance verification.
• Review the Investigator Site File (ISF) for accuracy and completeness.
• Document activities through confirmation letters, trip reports, and communication logs.
• Support subject/patient recruitment and retention strategies.
• Understand project scope, budgets, and timelines, managing site-level activities.
• Act as primary liaison with study site personnel and ensure compliance with training requirements.
• Prepare for and attend Investigator Meetings and sponsor meetings.
• Provide guidance towards audit readiness standards and support audit preparations.
• May supervise, train, and mentor junior CRAs.
• For Real World Late Phase (RWLP), additional responsibilities include:
• Site support throughout the study lifecycle.
• Chart abstraction activities and data collection.
• Collaborate with Sponsor and local staff.
• Train junior staff as needed.
• Identify and communicate out of scope activities.
• Propose potential sites based on local knowledge.
• Identify operational efficiencies and process improvements.
• Develop informed consent forms.
• Collaborate with RWLP Regulatory team.
• Participate in bid defense meetings and provide input into RFPs.
• Participate in Case Report Form design and edit check development.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Good computer skills and ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Moderate level of critical thinking skills expected.
• Ability to manage required travel of up to 75% on a regular basis.

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.
• Collaboration with smart colleagues from across the world.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping them navigate complexity and accelerate progress.

• Worked with 94% of all Novel FDA Approved Drugs in the past 5 years.
• Collaborated on 95% of EMA Authorized Products.
• Conducted over 200 Studies across 73,000 Sites and 675,000+ Trial patients.