Senior Clinical Research Associate
vor 3 Wochen
Clinical/Medical Research (Healthcare & Medical)
OncoRes Medical was founded at the intersection of medicine, science and humanity to improve the accuracy of breast-conserving surgery and eliminate the physical, psychological and economic burdens associated with repeat operations.
Our unique, informal culture champions vision, restlessness and humanity.
Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership.
We have a shared passion to work restlessly, pioneering change to re-imagine the world, while remaining grounded in our commitment to science and quality.
Our passion for helping patients focuses us on the patient.
We believe that all breast cancer patients deserve the opportunity to move beyond their breast cancer surgery knowing that all the cancer has been removed, the first time.
In everything we do, we are thinking about how we can inch closer to a world free from re-excisions... We are going BEYOND BREAST CANCER
Overview:
The Senior Clinical Research Associate at OncoRes Medical will be responsible for supporting the successful and timely delivery of clinical trials conducted by OncoRes Medical.
The successful candidate will be expected to work within the clinical program team and support ongoing clinical trial activity.
The role, ideally based in Melbourne, will provide a hybrid working model and involve interstate travel as part of trial-related activities If you want to use your expertise to support sponsor activities and help develop a novel, disruptive medical product that will impact the lives of millions of people around the world, get in touch
This is a unique opportunity to get involved in an early, rapidly growing company with significant growth and development opportunities for the right candidate.
Duties:
Support all aspects of sponsor responsibility in conducting clinical trial activities according to ICH GCP requirements, including, but not limited to:
Support clinical study documentation writing, as well as ethics submissions and amendments.
Conduct training of site staff in the use of the investigational medical device, trial protocol and procedures.
Liaison with sites and third-party vendors, such as the Clinical Research Organisation (CRO) or data management company supporting clinical trial activity.
Support clinicians intra-operatively in the use of the investigational medical device.
Combination of working from home, in office, at sites, as well as interstate travel (25% of time).
Participation and support of team during vendor meetings, virtual and face-to-face and in house team meetings.
Serve as an ambassador to promote OncoRes Medical's core values; we are Inspired, Restless, Human and Visionary.
Qualifications/Experience
Degree in life sciences (e.g., science, medical science, medicine, nursing)
Training in ICH-GCP and local regulatory requirements for clinical trials.
2-3 years of experience as CRA.
Previous medical device trial experience is highly desirable.
Experience as CRA or equivalent at medical device/start-up company
Skills
Interest in science and clinical research.
Strong analytical skills to problem solve and resolve issues as raised by sites or the sponsor.
Confident communicator and a desire to be well-prepared for meetings, visits, presentations, and calls.
Efficient and clear in writing reports and meeting minutes.
Able to meet deadlines and have an enthusiastic 'can-do' attitude.
Ability to take responsibility in the quality and outcomes of work.
Works well in a project team (including remotely) and respect other team members.
Ability to remain professional and positive in all personal interactions, and work with honesty and transparency while being committed to doing what's best for our patients, customers and company.
Qualified candidates must be legally authorized to be employed in Australia.
Willingness to adapt role to project requirements.
Comprehensive and competitive remuneration packaging including access to the employee phone allowance.
A flexible and fun workplace where we understand that your life is more than your job.
A rare opportunity to work closely alongside world-class colleagues and mentors with many collective years of experience in all aspects of medical device development and commercialisation at sponsor level.
All of us share a passion for working collaboratively where every voice is heard, and your personal and professional development is a high priority.
OncoRes is committed to building and fostering an inclusive, diverse workplace.
We believe the differing perspectives and experiences each of us brings inevitably increases innovation and teamwork, flowing into positive tangible outcomes.
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