CRA II Sydney

Syneos Health, Inc.; South Australia; On-site; AUD 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical solutions organization in Australia is seeking a qualified professional for site management related to clinical trials. The role requires performing monitoring activities and ensuring compliance with regulations while supporting subject recruitment and retention strategies. Candidates should have a Bachelor’s degree or RN, excellent communication skills, and the ability to manage substantial travel. This position emphasizes teamwork and collaboration in a dynamic working environment.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 75%.

Responsibilities

• Perform site qualification and management activities.
• Verify informed consent and maintain confidentiality.
• Conduct Source Document Review of medical records.
• Manage investigational product inventory and security.
• Document activities via confirmation letters and reports.
• Support subject recruitment and retention strategies.
• Act as primary liaison with study site personnel.
• Prepare for investigator meetings and global monitoring staff meetings.
• Maintain working knowledge of ICH/GCP Guidelines and regulations.

Skills

Communication skills

Interpersonal skills

Computer skills

Education

Bachelor’s degree or RN in a related field

Job description

Updated: December 23, 2025
Location: Adelaide, SA, Australia
Job ID:25104757

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

We bring the customer and the patient to the center of everything we do and continuously simplify and streamline our work to make Syneos Health easier to work with and to be easier to work for.

Job Responsibilities

• Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Evaluate overall site performance and provide recommendations. Escalate serious issues to project team.
• Verify informed consent process and maintain confidentiality of subjects. Assess safety and data integrity issues, including protocol deviations and pharmacovigilance issues.
• Conduct Source Document Review of site source documents and medical records. Verify required clinical data in CRF is accurate and complete. Resolve queries and drive closure within agreed timelines.
• Perform investigational product inventory, reconciliation, and review storage and security. Verify IP dispensation and administration per protocol and manage IP labeling and release.
• Review Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconcile ISF contents with Trial Master File (TMF). Ensure archiving of essential documents per local regulations.
• Document activities via confirmation letters, trip reports, communication logs, and required project documents per SOPs and monitoring plan.
• Support subject recruitment, retention, and awareness strategies. Enter data into tracking systems to monitor observations and action items.
• Manage site‑level activities, communication, and project objectives to meet deliverables and timelines.
• Act as primary liaison with study site personnel and collaborate with Central Monitoring Associate; ensure training and compliance.
• Prepare for and attend Investigator Meetings and sponsor face‑to‑face meetings. Participate in global monitoring staff meetings.
• Provide guidance at site and project level toward audit readiness; support audit preparation and follow‑up actions.
• Maintain working knowledge of ICH/GCP Guidelines, regulations, and company SOPs/processes; complete required training.
• Support the study lifecycle from site identification through close‑out and perform chart abstraction and data collection as needed.

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.
• Ability to manage required travel of up to 75% on a regular basis.
• US ONLY: Compliance with site access medical and personal information requirements; failure to provide requested information may result in site barring entry.

Syneos Health® is an equal opportunity employer committed to diversity, equity, and inclusion.