Senior Clinical Research Associate

18 hours ago

Brisbane, Queensland, Australia beBeeClinicalResearch Full time
Key Responsibilities for Clinical Research Associate Role

The primary focus of this position is to monitor investigator sites with a risk-based approach, ensuring compliance and data accuracy through on-site and remote monitoring activities.

Responsibilities:

  • Monitor investigator sites using a risk-based approach, identifying site processes failures and implementing corrective actions.
  • Review SDR, SDV, and CRF as applicable to ensure data accuracy.
  • Assess investigational products through physical inventory and records review.
  • Document observations in reports and letters in a timely manner using approved business writing standards.
  • Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  • Conduct supervising tasks in accordance with the approved monitoring plan.
  • Participate in investigator meetings as vital.
  • Help identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
  • Perform trial close-out and retrieval of trial materials.

Required Skills and Qualifications

To succeed in this role, you should possess:

  • A Bachelor's degree in a life sciences-related field or a Registered Nursing certification.
  • Minimal 1-2 years of clinical monitoring experience, preferably in therapeutic areas like oncology.
  • Phase I experience is essential.
  • Basic medical/therapeutic area knowledge and understanding of medical terminology.
  • Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations.
  • Good oral and written communication skills.
  • Good interpersonal skills.
  • Ability to manage Risk-Based Monitoring concepts and processes.
  • Ability to work in a team or independently as required.

Benefits

This role offers:

  • Competitive remuneration and annual incentive plan bonus.
  • Range of employee benefits, including health & wellbeing programs, flexibility, extra leave, charitable giving & volunteering, learning & development opportunities.
  • Thermodynamic environment that fosters innovation, intensity, involvement, and integrity.

Requirements

Please note the following requirements:

  • Home-based position based in Melbourne, Sydney, or Brisbane.
  • Must have excellent organizational and time management skills.
  • Must be well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem-solving.
  • Must have good digital literacy, solid knowledge of Microsoft Office and ability to learn software.

How to Apply

If you are passionate about delivering quality and accuracy in clinical research, apply now to discover new career opportunities and grow your professional network.

Company Overview

Our organization provides innovative solutions for various industries, fostering a collaborative environment that empowers our employees to make a positive impact worldwide.

Additional Information

We offer flexible arrangements and generous leave policies, allowing you to balance your work and personal life. Please refer to our website for more details on our employment offerings and company culture.

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