Medical Devices jobs in Melbourne VIC

Independent Clinical Research Associate (CRA) / Clinical Monitor – Australia

Location: Australia (Remote with travel as required)

Employment Type: Contract / Freelance

About Us

We are a U.S.-based Clinical Research Organization (CRO) dedicated to providing high-quality clinical trial management and clinical operations support to pharmaceutical, biotechnology, and medical device companies. As we continue to expand our global network, we are seeking an experienced Independent Clinical Research Associate (CRA) / Clinical Monitor based in Australia to support upcoming Phase II–IV clinical trials across multiple therapeutic areas.

This role offers an exciting opportunity to work collaboratively with international sponsors, investigators, and project teams while contributing to the successful execution of clinical research studies throughout Australia.

Position Summary

The Clinical Research Associate (CRA) will be responsible for monitoring assigned clinical trial sites to ensure studies are conducted in accordance with the study protocol, ICH-GCP guidelines, applicable regulatory requirements, and sponsor Standard Operating Procedures (SOPs). The CRA will serve as the primary point of contact between the sponsor/CRO and investigative sites, providing ongoing support to ensure subject safety, data quality, and regulatory compliance.

Key Responsibilities

· Conduct Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Routine Monitoring Visits (RMVs), and Close-Out Visits (COVs).

· Monitor clinical trial sites to ensure compliance with study protocols, ICH-GCP, and local regulatory requirements.

· Perform Source Data Verification (SDV) and Source Data Review (SDR) to ensure data accuracy, completeness, and integrity.

· Review informed consent documentation, eligibility criteria, protocol compliance, and investigational product accountability.

· Identify protocol deviations and support sites with corrective and preventive actions.

· Prepare monitoring reports, follow-up letters, and other required documentation within established timelines.

· Collaborate with investigators, study coordinators, project managers, data management teams, and sponsors throughout the study lifecycle.

· Support regulatory and essential document review as required.

· Maintain effective communication with assigned investigative sites to facilitate successful study execution.

· Participate in investigator meetings, sponsor meetings, and study-specific training as required.

Qualifications

· Bachelor's degree in Life Sciences, Nursing, Pharmacy, or another healthcare-related discipline.

· Previous experience as a Clinical Research Associate (CRA) or Clinical Monitor.

· Strong understanding of ICH-GCP, Australian clinical research regulations, and ethical guidelines.

· Experience conducting independent monitoring visits across multiple sites.

· Excellent written and verbal communication skills.

· Strong organizational, problem-solving, and time management abilities.

· Ability to travel within Australia as required.

Preferred Experience

Experience monitoring studies in one or more of the following therapeutic areas is preferred:

· Oncology

· Neurology

· Dermatology

· Endocrinology/Metabolic Disorders

· Women's Health

· Men's Health

· Cardiovascular

· Infectious Diseases

· Vaccines

· Rare Diseases

Experience with electronic data capture (EDC), CTMS, and eTMF systems platforms is desirable.

What We Offer

· Opportunity to collaborate with an expanding U.S.-based CRO on international clinical trials.

· Flexible contract engagement with competitive compensation.

· Exposure to diverse therapeutic areas and global sponsor programs.

· Opportunity to build a long-term relationship as our Australian clinical operations network continues to grow.

· Collaborative, quality-focused working environment with experienced clinical operations professionals.

How to Apply

· If you are interested in this opportunity, please submit:

· Your updated CV

· Current location within Australia

· Summary of therapeutic area experience

· Monitoring experience (SQV, SIV, RMV, COV)

· Availability (full-time, part-time, or freelance)

Application Question(s):

• Do you have a valid driver's license and reliable transportation to travel to and from assigned work locations?
• Are you currently residing in Australia and legally authorized to work in Australia?
• Do you have working knowledge of ICH-GCP guidelines and Australian clinical research regulations?
• Have you independently conducted Site Qualification Visits (SQV), Site Initiation Visits (SIV), Routine Monitoring Visits (RMV), and Close-Out Visits (COV)?

Willingness to travel:

• 50% (Required)

Work Location: In person