AddressAbout us:
Ingham Institute for Applied Medical Research (‘Ingham Institute’) is an innovative and growing not-for-profit organisation, committed to our vision of Inspiring Health and Transforming Care. At Ingham Institute we make and apply discoveries that translate into radical improvements in health, and healthcare for all.
We work closely with the South Western Sydney Local Health District, Western Sydney University, University of New South Wales, and have ambitious growth plans that will see us expand to be a multi-centre Institute (Liverpool, Macarthur, and Bankstown).
Our Opportunity:
The Clinical Trial Support Unit (CTSU) is based at the Ingham Institute and supports the start-up activities for Clinical Trials at the Ingham Institute, South Western Sydney Local Health District
The CTSU was established to build clinical trial capacity, research training opportunities and to improve community outcomes through implementation of evidence and innovation in health care.
We are recruiting for a Start-Up manager to join the CTSU to be responsible for acting as the key-contact for ethical or regulatory submission activities, ensuring that coordination for site start-up activities is aligned with the submission activities and studies are aligned to the critical path for site activation.
The Start Up Manager will also prepare, review and coordinate the local regulatory submissions (HREC, SSA, TGA, import licenses etc). They will develop collaborative relationships with Sponsors, Investigators and Clinical Trials teams as well as be able to negotiate and finalise site contracts and budgets as necessary
This position will be on a full-time basis on a maternity leave contract for 11 months.
Key duties and responsibilities will include but not limited to the following:
- Prepare and submit ethics and site-specific applications across multiple departments and therapeutic areas
- Prepare and negotiate budgets for Clinical Trials
- Act as the main point of contact for all start-up queries
- Provide professional customer interactions and admin support to clinicians and multidiscipline regarding start-up queries
- Maintain strict confidentiality in relation to all information particularly patient-related information
- Provide support with electronic Investigator Site Files (eISF), setting up new studies, uploading documents and maintenance of trials.
- Comply with regulations, institutional policies, and where applicable sponsor requirements.
- Actively assists the Manager to implement projects, processes and systems.
The successful candidate will posses the following essential criteria:
- Degree or demonstrated experience
- Previous experience with ethics, research governance submissions.
- Previous experience with budget and contract negotiations.
- Demonstrated administrative experience in a high paced department with proven communication and customer service skills.
- Demonstrated skills, initiative, analytical and problem-solving skills and the ability to source, coordinate and collate information.
- Excellent organisational skills, ability to meet deadlines with minimal supervision and prioritise work commitments.
- Previous experience using various computer packages e.g. Microsoft packages.
Benefits:
We offer a competitive salary and as a public health charity endorsed as a Deductible Gift Recipient, salary packaging opportunities are available to Institute employees.
Our office is located close to major shopping centres and transport hubs.
How to Apply:
To apply for this great opportunity, submit your updated resume alongside a cover letter via SEEK detailing your previous experience in a Start-up or Clinical Research Management related position and address the selection criteria above and demonstrate why you would be the best candidate for the role.
The successful candidate will be required to undergo a National Police Check.
Applications will only be considered from those candidates eligible to work in Australia.
Please note that only short-listed applicants and those who have included the correct application documents will be contacted.
