Clinical Research Professional

1 week ago

Melbourne, Victoria, Australia beBeeClinical Full time $105,000 - $155,000
Job Description

As a clinical research professional, you will work within a fast-paced environment alongside a close-knit team to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV.

The role involves independent, proactive work to set up and monitor studies, complete reports and maintain documentation, submitting protocol and consent documents for ethics/IRB approval, preparing regulatory submissions, balancing sponsor generated queries, taking responsibility for study cost efficiency, preparation and review of study documentation and feasibility studies for new proposals, and potential training and mentoring fellow CRAs.

Key responsibilities include:

  1. Setting up and monitoring studies, including completing reports and maintaining documentation.
  2. Submitting protocol and consent documents for ethics/IRB approval.
  3. Preparing regulatory submissions and balancing sponsor generated queries.
  4. Taking responsibility for study cost efficiency.
  5. Preparation and review of study documentation and feasibility studies for new proposals.
  6. Potential training and mentoring fellow CRAs.
Required Skills and Qualifications

To be successful in this role, you will need:

  • At least 18 months of monitoring experience in phase I-III trials as a CRA.
  • A college degree in medicine, science, or equivalent.
  • Previous monitoring experience in medium-sized studies, including study start-up and close-out.
  • Knowledge of ICH-GCP guidelines.
  • Ability to review and evaluate medical data.
  • Excellent written and verbal communication skills.
  • Ability to work to tight deadlines.
  • Availability to travel at least 60% of the time (international and domestic).
Benefits

This role offers the opportunity to work on complex clinical studies, develop your skills and knowledge, and contribute to the advancement of patients' lives.

Others

We are looking for a motivated and experienced individual who is passionate about clinical research and has excellent communication and organizational skills. If you are a detail-oriented and proactive person who is able to work independently and as part of a team, we would love to hear from you.

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