Contract Clinical Research Associate

This is a fully remote position, open to applicants in Australia.

📋 Description

• Execute site qualification, initiation, monitoring, and close-out visits

• Evaluate and identify appropriate investigative sites while assisting in site selection activities

• Educate site personnel on study protocols, regulatory standards, and study procedures

• Ensure sites adhere to GCP, local regulations, sponsor requirements, and study protocols

• Conduct source data verification and assess clinical documentation for precision, completeness, and consistency

• Oversee investigational product accountability, including storage, dispensing, and reconciliation

• Assist with submissions to Ethics Committees and Regulatory Authorities as needed

• Manage communications with sites, action items, and issue resolution throughout the study lifecycle

• Review and uphold essential study documentation within the Trial Master File (TMF)

• Facilitate resolution of data queries and ensure prompt reporting of study activities

• Cultivate and sustain relationships with investigators, study coordinators, and internal stakeholders

• Participate in study team meetings and contribute to the success of the project

⛳️ Requirements

• In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements

• Outstanding written and verbal communication abilities

• Strong organizational, time management, and problem-solving skills

• Capacity to effectively handle multiple priorities and deadlines

• Proficient in clinical trial systems and Microsoft Office applications

• Excellent interpersonal skills and ability to collaborate effectively within global teams

• Commitment to quality, accuracy, and patient safety

• Willingness to travel up to 75% as necessary

• Valid driver's license

• Bachelor's degree in Life Sciences, Nursing, or a related field, or an equivalent combination of education and relevant experience

• Successful completion of a recognized CRA training program

• Minimum of 3 years of clinical research experience, including roles such as Clinical Trial Associate, Study Coordinator, Clinical Research Associate, or similar positions

• Experience independently conducting site monitoring visits across all phases of a clinical trial

• Strong grasp of site management, protocol adherence, patient safety, and data quality standards

🏝️ Benefits

• Remote work arrangement

• Part-time schedule (0.4 FTE)

• Flexible working hours

• Opportunity to collaborate closely with investigative sites and cross-functional study teams

• Global team collaboration