Site Start Up Associate II / Senior Site Start Up Associate
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We're looking for a talented and energetic Site Start Up Associate II / Senior Site Start Up Associate to join our team in Australia!
This is a contract, duration of up to 1 year with an estimated start date of January 2021. The need is likely to be around 0.3 FTE.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As the Site Start Up Associate, you'll have the opportunity to showcase your expertise to perform all tasks with the start-up of a clinical trial in accordance with all regulations, standards, and study-specific requirements. You’ll be able to liaise and represent SSU with several members of the Study team as it pertains to Start-Up.
What you'll be doing:
- Prepare and submit Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions; prepare ongoing submissions, amendments, and periodic notifications required by central and local EC and RA; submit end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities.
- Perform essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with local regulatory requirements and ICH/GCP guidelines.
- Investigator Contract and budget negotiator - produce site contracts and submit proposed contract and budget for site; negotiate budget and contract with site and via Contracts Lead with Sponsor.
- Provide all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up; ensure accuracy and completeness of trial master file documents submitted during start-up and perform QC review before transfer to Maintenance for filing in TMF.
- Liaise with internal team members to review areas that impact study start-up and share start-up information with the project team.
- Provide country-level intelligence on site start-up and ensure that regulatory intelligence is maintained on the central repository; maintain a country folder with country Ethics Committees/Review Board and local authority addresses and requirements.
- Support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
- Review and advise on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements; provide training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.
You'll need this background to be considered:
- Undergraduate degree in a clinical, science, or health related field along with 2 years’ experience in the submission of clinical trial applications.
- Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials. Knowledge of site and institution specific contract requirements; proven proficiency in the development and review of Informed Consent Form templates
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job
- Strong verbal and written communication and negotiation skills; fluent verbal and written English required for clinical trial submissions
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment
- Is customer-service focused in approach to work, both internally and externally
- Maintain a positive working environment that embodies a culture of aspiration, caring, empowerment and a #oneteam approach