Senior Study Startup Associate 18-months contract
Senior Study Startup Associate 18-months contract
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Job Description
Take your career to the next level and lead challenging study activation process on a country/regional level. You will support clinical research teams and ensure PSI projects start smoothly and on time.
Were looking for a Senior Study Startup Specialist on a 18month contract to support our increased workload. This is a great opportunity for someone looking to gain handson experience in clinical research.
Office based in Macquarie Park NSW
- Identifies and escalates operational issues to Project Management and other functions concerned.
- Leads activities in feasibility research and site identification process.
- Provides startup support for selected projects starting from handover to Operations until all sites are activated.
- Prepares and submits the study dossiers to investigators/institutions competent authorities IRBs/IECs and/or to other review bodies/research committees as required by applicable regulations.
- Participates in regional kickoff meetings/calls.
- Coordinates and supports contract negotiation process.
- Coordinates and supports preparation of IPRED packages.
- Monitors startup key performance indicators for selected projects on country level.
Qualifications :
- College or University degree or an equivalent combination of education and experience that provides the individual with the required knowledge skills and abilities
- Minimum of 4 years of industry experience in clinical research as a Study Startup Specialist or similar position with practical study startup experience in the Australia
- Excellent knowledge of FDA guidelines and ICH GCP
- Communication and interpersonal skills
- Attention to detail
- Ability to work in a team or independently
Additional Information :
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward and well be there with you every step of the way. We will guide and support you with information making your experience as smooth as possible.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
