senior clinical research associate in Melbourne

posted
contact
melissa tuli, randstad
job type
permanent
salary
AU$ 90,000 - AU$ 100,000 per year

job details

posted
location
melbourne, victoria
specialism
healthcare & medical
job type
permanent
working hours
Full-Time
salary
AU$ 90,000 - AU$ 100,000 per year
reference number
90M0423944_1598599782
contact
melissa tuli, randstad
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job description

The Company:

Our client is a global Pharmaceutical company based in Melbourne CBD. Due to recent growth, they are looking for a Senior Clinical Research Associate to join their team. This role will support the clinical team worldwide, with a particular focus on monitoring Australian sites for clinical trials. As a Clinical Specialist (CRA) you will be involved in the creation of study documents and management of timelines of clinical trials.

Key duties and responsibilities:

Your main duties within this role will include but not limited to the following;

  • Feasibility assessments/visit evaluations for clinical and post-authorization studies
  • Site setup for the commercial distribution according to post-authorization requirements
  • Site setup for clinical trials
  • Site management: investigating, following up and escalating site issues as needed.
  • Delivery of data accuracy through CRF review through on-site and remote monitoring according to the monitoring plan to ensure patient safety and compliance.
  • Assistance with Pharmacovigilance, safety reporting management and investigations of quality complaints
  • In-house/ on-site document quality management (including, but not limited to, trial master file, investigator site file).
  • Communicate effectively with internal and external stakeholders

Qualifications and experience:

  • Bachelors degree in Science, Nursing, Pharmacy, or other related disciplines
  • Minimum 2 years of experience as a CRA/Clinical Monitor/Clinical Specialist
  • Understanding of ICH GCP guidelines and Australian regulatory requirements
  • Understanding of international regulatory requirements.
  • Effective time management of multiple tasks
  • Deliver high quality customer services to internal/external customers
  • High attention to detail

If you feel that you would be suitable for this role click "APPLY NOW" or alternatively email Melissa Tuli on Melissa.tuli@randstad.com.au to discuss the role further.

Note – Due to COVID 19 and Work from home arrangements, we are accepting email enquiries only.

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

skills

clinical research, cra, scra, clinical specialist, clinical monitor

qualification

Bachelor's degree

educational requirements

Bachelor Degree