Introduction
Australia's healthcare sector is not just a backdrop but an active player in the global clinical research arena. Renowned for its cutting-edge medical research institutions, state-of-the-art facilities, and robust pharmaceutical industry, the country offers a fertile ground for those seeking to contribute to advancements in medical science.
Embarking on a career in clinical research opens a world of possibilities, especially in the thriving landscape of Australia.
This blog is all about the exciting roles of Clinical Research Assistants, Associates, and Coordinators, shedding light on the demands, responsibilities, and pathways for success.
Clinical Research Assistant
Clinical research associates are healthcare professionals who conduct medical research and clinical trials. Clinical research associates are employed by a variety of organisations, including pharmaceutical firms, government agencies, and medical research facilities.
Roles and Responsibilities
A clinical research assistant participates in all phases of the clinical study. These include choosing an investigational site and setting up, starting, running, and concluding the experiment. They work on both new and existing medications.
Clinical Research Assistants are the ones who undertake clinical trials to test how effective, lethal/risky and beneficial a drug is. They ensure that a drug is safe for its intended use. Some other roles and responsibilities include the following-
- Check and track all clinical trials
- Assess, evaluate and take detailed notes on clinical trials
- Recruit and enrol study participants.
- Communicate with study participants
- Organise spreadsheets and sort data
- Ensure regulatory compliance with all protocols
- Input data obtained from clinical research
- Create informed consent for clinical trials
- Prepare and present findings of research
- Organise focus groups and design experiments
- Prepare documentation of study protocols
- Collect initial research data through surveys and focus groups
Clinical Research Associate
A Clinical Research Associate (CRA) is a professional responsible for overseeing and managing clinical trials. CRAs ensure that trials are conducted in adherence to protocols, regulatory requirements, and ethical standards. They conduct site visits to monitor data collection, verify participant safety, and ensure the overall integrity of the study.
Roles and Responsibilities
- Conducting pre-study site visits, gathering and reviewing data, and creating an evaluation report.
- Participating in the final selection of investigation and study sites. Contributing to identifying possible investigations and clinical sites, both domestically and globally.
- Assisting in finding centralised services like clinical laboratories and contract research firms; evaluating experience and qualifications in connection to proposed research activities, and taking part in the final selection.
- Overseeing the hiring, training, goal-setting, and task distribution of the technical and/or administrative staff involved in conducting research
- Participating in the formulation of baseline parameters and edit check requirements, the construction of subject tracking systems, and the implementation of monitoring and reporting protocols, methods, guidelines, and tools that are specific to a given study.
- Assisting in the termination of clinical trials by identifying items and issues that need to be reviewed and/or followed up on
- Gathering required documentation
- Conducting site termination visits that involve test article reconciliation and disposition
- Examination of the accuracy and completeness of documents, and retrieval of relevant codes and documents
- Creating study termination reports
- Conducting Miscellaneous duties
- Conducting site visits for the beginning of clinical trials
- Providing site staff with guidance and training on sponsor and regulatory requirements for study
- Participating in and/or running site meetings and multicenter investigator meetings, and creating reports.
Clinical Research Coordinator
A Clinical Research Coordinator (CRC) is a vital clinical research team member responsible for managing a clinical trial's day-to-day activities. CRCs collaborate closely with principal investigators, ensuring protocol adherence, participant recruitment, and accurate data collection.
They play a pivotal role in obtaining informed consent, maintaining regulatory compliance, and serving as a liaison between sponsors, research sites, and ethics committees. CRCs contribute to the smooth operation of clinical trials, emphasizing participant safety and data integrity throughout the research process.
Roles and responsibilities
- Ensure strict adherence to the study protocol, outlining guidelines and procedures.
- Actively participate in recruiting and enrolling eligible participants, ensuring compliance with criteria.
- Obtain informed consent, explaining study details, potential risks, and benefits clearly.
- Oversee accurate and timely data collection, maintaining detailed records for data integrity.
- Ensure compliance with regulatory requirements and ethical standards, obtaining necessary approvals.
- Manage day-to-day activities at the research site, coordinating with investigators, sponsors, and stakeholders.
- Monitor participants throughout the study, addressing concerns, and reporting adverse events in line with guidelines.
- Implement quality control measures for accurate and reliable data, conducting regular site audits.
- Maintain comprehensive study documentation, preparing and submitting reports to regulatory agencies, sponsors, and ethics committees.
- Act as a liaison between the principal investigator, sponsors, study monitors, and research team members, ensuring effective communication and collaboration.
- Provide training to study staff, ensuring informed and proper procedures.
- Assist in budget management, and tracking study-related expenses for cost-effectiveness.
Salary
Clinical Research Assistant
In Australia, the average salary for a Clinical Research Assistant stands at $69,109. Typically, the salary range falls between $57,400 and $77,200, reflecting variations based on factors such as experience, qualifications, and other relevant considerations.
Clinical Research Associate
In Australia, the average annual salary for a Clinical Research Associate is $90,744 or $46.54 per hour. Entry-level roles typically commence at $85,363 per year, with seasoned professionals earning up to $126,938 annually.
Meanwhile, in India, the average yearly salary for a Clinical Research Associate is 400,000 or 205 per hour. Entry-level positions usually begin at 300,000 per year, while highly experienced individuals can potentially earn up to 600,000 per year.
Clinical Research Coordinator
The typical annual salary for a Clinical Research Coordinator in Australia averages $96,262 or $49.37 per hour, with entry-level roles starting around $81,920 per year and seasoned professionals earning up to $117,627 annually.
In India, the average annual salary for a Clinical Trials Coordinator is ₹300,000 or 154 per hour, with entry-level positions beginning at 242,500 per year and experienced individuals potentially earning up to 600,000 per year.
Educational Requirements for Clinical Research
Becoming a Clinical Research Associate, Assistant, or Coordinator has evolved over time. While previously a science degree or medical field experience sufficed, the current landscape demands a more structured approach. Today, aspiring individuals typically follow these pathways:
Educational Background
Obtain an undergraduate degree in life sciences, pharmacy, nursing, biotechnology, AYUSH, dentistry, or medical sciences.
Specialised Training
Complete a diploma or certification in clinical research from a reputable institution, enhancing your knowledge and skills in the field.
Additional Qualifications
For those without a science degree, substantial administrative expertise in clinical research can be an alternative qualification.
Adaptation to Industry Changes
The landscape has evolved, and now, securing a position in clinical trials or research often requires completing a certificate program in clinical trials. These programs cover essential topics and specifications for clinical research.
Global Relevance
If you are a working professional or student with a science or healthcare degree from India or Pakistan aspiring to work as a clinical research associate in Australia or New Zealand, it is advisable to complete a certificate program that aligns with the standards of clinical research.
Your Path to Success
Academically has introduced a cutting-edge clinical research program meticulously crafted to cover the entire GCP curriculum, aligning with the specific needs of Australia and New Zealand's clinical research industry for entry-level positions.
This course is tailored to furnish you with the essential skills and knowledge required for a successful role as a Clinical Research Assistant, Associate or Coordinator.
At Academically, we go beyond the educational aspect. We are committed to assisting you in building a compelling CV and cover letter, and we offer comprehensive interview preparation to enhance your confidence and readiness for the job market.
Upon course completion, you will receive a certificate, a valuable credential that enhances your prospects of securing a position as a clinical research coordinator in esteemed government and private organizations.
For further details about the course and to embark on your journey toward becoming a Clinical Research Assistant, Associate, or Coordinator, consult with the experts at Academically. Your rewarding career in clinical research awaits!
