AddressOpportunity
Due to increased growth, we are looking for enthusiastic and talented individuals to join our clinical operations team. Preferred location within either Adelaide, Melbourne or Sydney, but open to other regions.
Full-time is preferred, but will consider part-time.
Clinical Research Associates (CRAs) play a crucial role in ensuring our clinical research projects are executed with the quality that each client and project requires. They are the driving force of clinical operations and play a lead role in every clinical trial.
With the ever-evolving industry landscape, we offer an oasis where we value our people by providing a flexible working setting and a collaborative environment where everybody’s experience, opinions and ideas are not only heard but actively sought after.
We have a values-driven culture that is built from the ground up. Our leaders are at the frontline with you- committed to advancing science and going above and Beyond for our clients but most importantly, for our team.
As a boutique early phase CRO we offer a unique opportunity to be a part of an incredibly exciting journey in the establishment of one Australia’s newest CRO’s – one you can’t get anywhere else, with a team unlike any other.
What you will do
- Responsible for managing the research activities at Australian sites (largely early phase research) both private/public research sites
- Be in communication with the medical site staff including coordinators, clinical research physicians, and their site staff
- Conduct all types of visits – site qualifications, initiation, monitoring and close out visits
- Ensure adherence and compliance with ICH -GCP and applicable local and international regulations and Standard Operating Procedures (SOPs)
- Assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
- On-site and (where required) remote monitoring activities. This will require interstate travel
- Support Clinical Project Manager and other team members as required
- For Senior Clinical Trials Administrator entry level: Attend training programs and be supported in co-monitoring visits as part of training
What you will bring to the role
- A degree in life sciences or equivalent
- Senior Clinical Trial Assistant level (3-4 years minimum in this role preferred) or above
- Solid knowledge of ICH GCP
- Knowledge of Australian regulatory environment
- Excellent interpersonal, oral, and written communication skills in English
- Superior organizational skills with attention to detail
- Knowledge of the pharmaceutical industry, terminology, and practices
- Proficiency in Microsoft Office, CTMS, eTMF and EDC Systems
Beyond Drug Development BDD
