Description

Senior clinical research associates (CRAs) handle the day-to-day operations of the clinical investigative phase of drug development. They are in charge of laboratory and research duties to reach all the organizational objectives. They need to have strong analytical aptitudes and pay strict attention to detail during all clinical research. They also handle experiment inquiries and take assessment notes on a frequent basis. Most senior clinical research associates are in charge of keeping investigative reports and providing project communications.Frequently, senior clinical research associates work in a lab setting, and their schedule can vary according to their projects and company needs.. They are responsible for monitoring experiment tools in this laboratory setting and any variables that may impact the research. They also must effectively train other research associates to operate complex equipment and follow proper laboratory conduct. They also work with different research professionals to share research results and reach different conclusions.A bachelor's degree in a scientific discipline, at minimum, is required for this position, as well as years of successful laboratory experience and additional certifications and or or education. These research associates need to have excellent interpersonal skills to cooperate in a team environment and deliver conclusions to research managers. They are also required to uphold ethical research practices and maintain advanced safety standards.

Roles & Responsibilities

As a Senior Clinical Research Associate CRA with 0-3 years of experience in Australia, your main responsibilities include:

  • Conducting site feasibility assessments, identifying potential study sites, and establishing relationships with investigators. Assess site suitability, identify potential study sites, and build rapport with investigators.
  • Coordinating and overseeing the initiation, monitoring, and close-out activities of clinical trials. Manage trial initiation, monitoring, and closure, ensuring compliance with protocols and regulations.
  • Performing source data verification, ensuring accuracy and completeness of data collected during the trial. Verify source data for accuracy and completeness, maintaining high data quality standards.
  • Assisting in the preparation and review of study documentation, such as protocols, case report forms, and informed consent documents.

Qualifications & Work Experience

For a Senior Clinical Research Associate (CRA), the following qualifications are required:

  • The candidate should have a strong background in clinical research and a deep understanding of Good Clinical Practice (GCP) guidelines. They should have worked on multiple clinical trials, demonstrating their knowledge of study protocols, data collection, and management.
  • A Senior CRA should be able to identify and address issues that arise during clinical trials effectively. They should have the ability to analyze complex clinical data, identify trends, and propose appropriate solutions to ensure the integrity of the study.
  • It is crucial for a Senior CRA to have exceptional communication skills to effectively communicate with study investigators, site personnel, and sponsor representatives. They should be able to build strong relationships and effectively collaborate with cross-functional teams.
  • As a Senior CRA, attention to detail is essential to ensure data accuracy and project timelines are met.

Essential Skills For Senior Clinical Research Associate (CRA)

1

Clinical Research

2

Research and Analysis

3

Project Management

4

Research Methods

Career Prospects

The role of a Senior Clinical Research Associate CRA is crucial in the field of clinical research. For individuals with 0-3 years of work experience in Australia, here are four alternative roles to consider:

  • Clinical Trial Coordinator: A position that involves coordinating and managing various aspects of clinical trials, including participant recruitment, data collection, and regulatory compliance.
  • Clinical Research Assistant: An entry-level role that supports the CRA in conducting research activities, data management, and administrative tasks.
  • Clinical Data Manager: A role focused on ensuring the accuracy, integrity, and security of clinical trial data, including data collection, validation, and database management.
  • Regulatory Affairs Associate: A position that involves ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and liaising with regulatory authorities.

How to Learn

The projected growth of the Senior Clinical Research Associate (CRA) role in Australia is expected to be significant. According to a 10-year analysis, there will be a substantial increase in employment opportunities for CRAs. Google data suggests that the demand for CRAs is steadily rising due to the growing emphasis on clinical research in the healthcare industry. With the increasing complexity of clinical trials and the development of new medical treatments, the need for skilled CRAs is anticipated to grow consistently. This trend indicates a promising future for individuals seeking employment in this field in Australia.