Study Start up Specialist II / III – Australia Based
Who are we?
We're Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980's. If you already work in this industry you'll know that we are experts in our field.
Why should you join Avance Clinical?
At Avance we know our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.
In the last 12 months we've promoted 23% of our people so we're seeking people that thrive in a positive environment, who are inquisitive and keen to have a genuine opportunity to learn and grow in a business that is expanding.
The role
The Study Start-Up Specialist II / III (SSU II / III) is responsible for executing site start up activities from the point of site selection through to activation, supporting ongoing activities during site maintenance and close-out, in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. They will report study progress to the Project Manager (PM), and they will directly interact with sponsors.
Please note – this role is Australia based – you can work remotely from within Australia.
Core Responsibilities
* Develop and manage integrated site start-up timelines and regularly report progress including plans to address potential timing risks/gaps. If planned timelines are not reached, analyse data to provide clear rationale for delays, provide contingency plans to mitigate impact, and escalate the issue as soon as identified.
* Serve as the primary contact with the Investigator sites, study Sponsor and Avance PM/Lead CRA.
* Report on status/metrics at sponsor meetings and communicate outcomes to project team.
* Draft country-level budgets, site-level budgets; development, negotiation, and completion of Clinical Trial Research Agreements (CTRA)/Clinical Trial Agreement (CTA) if required.
* Manage Ethics Committee (EC)/ Independent Ethics Committee (IEC) / Institutional Review Board (IRB) submissions and approvals for assigned protocols (and subsequent amendments), development of local language materials including Informed Consent Forms per local regulations, interactions with EC/IEC/IRB or investigator sites.
* Draft clinical trial Regulatory Authority (RA) submissions and monitor on-going maintenance requirements.
* Manage clinical trial public registry submissions and on-going maintenance.
* In conjunction with Avance's Regulatory Affairs department, manage and/or oversee Investigational Product importation licenses.
* In conjunction with Clinical Operations team, manage the collection of Essential Documents leading to site activation.
* Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
* Provide guidance and mentoring to less experienced SSU staff members.
* Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.
Qualifications, Skills and Experience
* Bachelor's level degree in life sciences, pharmacy, nursing, or equivalent field (highly regarded), or appropriate industry experience.
* Previous SSU experience in a CRO, Pharma company or equivalent clinical trial setting for at least 3 years.
* Working knowledge of ICH GCP and applicable regulatory requirements.
* Clear understanding of the requirement to adhere strictly to client confidentiality.
* Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
* Demonstrated ability to take initiative in problem solving and in exercising good judgment.
* An understanding of Privacy Legislation as it applies to the Clinical Trial Environment.
* Ability to work under pressure in a multi-disciplinary team environment.
* Willingness to work in, and be supportive of, a positive and dynamic team culture.
* Ability to travel (desirable).
What we offer
* Stimulating work
* Project diversity
* An intellectual challenge
* Opportunity to progress
* Stability
* Sense of community
* A leadership team that are working together on a common goal
* Great tools / tech to do your job
* A competitive salary & an extra days holiday for your birthday
What next?
As a growing business we're looking for likeminded people to join us – we hope that's you.
* To join our team please submit your CV & cover letter as one Microsoft Word document
* You must be based in Australia & have full Australian working rights to be considered as we're not looking to provide sponsorship for this role
At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
Study Start Up / ICH GCP / Clinical Trials / SSU / CRO / Adelaide / Brisbane / Melbourne / Sydney / Australia