Overview
Site Specialist (Clinical Trials) Australia | Work from home anywhere in Australia. Previous Clinical Trials experience of 2 plus years required. Growing CRO.
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 and have an exceptional reputation for supporting our people.
Why should you join Avance Clinical?
We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team & support. We've doubled in size in the last 3 years and have promoted over 23% of our people in the last 12 months.
Broad Purpose
The Site Specialist supports activities of the feasibility and site strategy team. The role is involved in the identification, and engagement of clinical trial sites for projects where Avance is being considered for or has been selected to manage execution of clinical trials. In performing their role, the Site Specialist works and collaborates with Avance staff in other Avance departments including business development, scientific/regulatory and clinical operations, as well as external stakeholders (e.g. clinical investigators, clinical trial site coordinators).
Core Responsibilities
* Develop and maintain relationships with key opinion leaders, clinical investigators and relevant clinical research site personnel corresponding to the geographical location of their assigned responsibility across multiple therapeutic areas.
* Assess clinical trial feasibility through review of study information/materials provided by Avance's clients (e.g. draft summaries, protocol synopsis, protocols) and identify potential barriers for attracting investigator interest and/or patient enrolment.
* Provide clinical trial accrual projections through analysis of historical data and current trends in relevant clinical research and recommend geographical locations and clinical sites that can meet enrolment and study timeline objectives. Activities include but are not limited to:
* Searches using subscription systems/databases (e.g. Trial Hub).
* Public database mining (e.g. PubMed, ClinicalTrials.gov).
Core Activities (cont.)
* Support project specific investigator/site reach out and collection of relevant trial accrual and site capabilities data. Activities include but are not limited to:
* Prepare a study specific feasibility questionnaire.
* Review feasibility results and report on findings to stakeholders as required.
* Facilitate calls between sponsor and potential investigators.
* Liaise with project teams to evaluate status and progress of site identification, to identify and highlight any potential risks or issues to timelines or objectives.
* Maintain accurate and detailed documentation of site assessment processes, decisions, and communications.
* Liaise with internal and external stakeholders, including clinical operations, scientific/regulatory affairs, clinical investigators and site coordinators, to gather and interpret data relevant to site selection.
* Ensure capture of strategy intelligence relating to clinical trial sites, investigators (e.g. performance in terms accrual, quality, compliance) in an appropriate software-based system (e.g. Veeva Vault).
* In conjunction with the Manager, Strategic Site Solutions plan and execute site-level feasibility analyses for awarded projects to support Clinical and Project Operations, as per activities outlined above.
* Ensure all site selection processes comply with regulatory standards and ethical guidelines.
* Other duties as required.
Business Development Responsibilities
* Provide/present country and site level site feasibility analyses to support pre-award business development efforts including proposals and bid defence processes.
* Support effective project transition from BD to Operations in relation to site identification and selection.
Qualifications, Skills, and Experience
* Bachelor's level degree in life sciences, public health, nursing or related field.
* Industry experience in appropriate positions that complement the requirements of this position (including a minimum of 2 years' experience in the biotech/pharma/CRO/trial site industry working in a GCP environment).
* Prior knowledge / experience in Oncology, CNS, Dermatology, Ophthalmology preferred.
* Knowledge of appropriate local regulatory guidelines and Ethics Committee requirements.
* Formal ICH GCP training and a working knowledge of ICH GCP Guidelines and other 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.
* Excellent organizational skills, written and oral communication, and interpersonal skills are required.
* Demonstrated ability to take initiative in problem solving and in exercising good judgment.
* Awareness of Privacy Legislation as it applies to the Clinical Trial environment.
* Ability to work under pressure in a multi-disciplinary team environment.
* Demonstrated initiative, reliability and ability to work unsupervised.
* Ability to build and maintain trust and confidence and communicate effectively with internal team members, clients, and external vendors.
* Willingness to work in, and be supportive of, a positive and dynamic team culture.
* Ability to travel. Occasional travel may be required.
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 yourCV & cover letter as one Microsoft Word document
* You must have full Australian working rights to be considered
At Avance difference is encouraged, its celebrated and it's something we strive for. We empowercultural, disability, LGBTI+, and gender equality.
Clinical Trials / Site / Feasibility / Life Science / Adelaide / Sydney / Brisbane / Melbourne / Perth
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