Remote Study Start-Up Specialist I (Australia)

Avance Clinical Pty Ltd.; City of Melbourne; On-site; AUD 70,000 - 110,000; Full time

Benefits offered by this job

Stimulating work

Project variety

Intellectual challenge

Career progression

Job stability

Sense of community

Great tools/tech

Birthday day off

Job summary

Avance Clinical is seeking a Study Start Up Specialist I based in Australia, with remote options within the country. You will drive site start-up activities from site selection to activation, interact with sponsors, and support ongoing maintenance and close-out in line with ICH GCP and SOPs.

The role requires a life sciences degree and SSU exposure in CRO/pharma settings, plus strong communication, problem solving, and privacy compliance.

Qualifications

• Bachelor’s degree or equivalent in life sciences, pharmacy, nursing or related field.
• 1+ years SSU experience in CRO/pharma/clinical trial setting.
• Working knowledge of ICH GCP and regulatory requirements.
• Strong written and oral communication with clients and stakeholders.
• Ability to work under pressure in a multi-disciplinary team.
• Understanding of privacy legislation in clinical trials.
• Willingness to travel (desirable).

Responsibilities

• Develop and manage site start-up timelines and report progress.
• Serve as primary contact with Investigator sites, Sponsor and Avance PM/Lead CRA.
• Report status/metrics at sponsor meetings and communicate outcomes.
• Draft country- and site-level budgets and CTAs/CTRAs as needed.
• Manage Ethics Committee/IRB submissions and local language materials.
• Draft regulatory authority submissions and monitoring maintenance.
• Oversee public registry submissions and updates.
• Assist in product import licenses with Regulatory Affairs.
• Coordinate Essential Documents collection for site activation.
• Participate in audits and respond to findings.
• Provide guidance to junior SSU staff.
• Other duties as directed.

Skills

Life sciences knowledge

Regulatory knowledge

Communication skills

Problem solving

Privacy compliance

Team collaboration

Travel flexibility

Education

Bachelor’s degree in life sciences/related

Job description

Avance Clinical is seeking a Study Start Up Specialist I based in Australia, with remote options within the country. You will drive site start-up activities from site selection to activation, interact with sponsors, and support ongoing maintenance and close-out in line with ICH GCP and SOPs.

The role requires a life sciences degree and SSU exposure in CRO/pharma settings, plus strong communication, problem solving, and privacy compliance.