Sr. Clinical Research Associate

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Clinical Research Associate based in Australia.

As a Senior Clinical Research Associate, you will independently oversee clinical site monitoring and management activities across assigned clinical studies.
You’ll serve as a key link between sponsors, investigative sites, and cross-functional study teams, helping ensure studies are conducted safely, accurately, and in compliance with applicable requirements.
The role spans site monitoring, recruitment and activation, study documentation, regulatory compliance, and ongoing site support.
You’ll work closely with investigators and site staff to maintain data quality, resolve issues, and keep studies aligned with timelines and milestones.
You’ll also contribute your expertise by mentoring junior CRAs and supporting quality, process improvement, and assessment activities.
The position offers a home-based working environment with regular travel to clinical sites and study-related meetings.
This is an opportunity to make a meaningful contribution to clinical research while working in a collaborative, accountable, and results-driven environment.

Accountabilities

• Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, routine monitoring, and close-out visits.
• Ensure all monitoring activities are performed and documented according to applicable SOPs, study plans, protocols, ICH-GCP guidelines, and local regulatory requirements.
• Review study data against source documentation to verify accuracy, completeness, consistency, and compliance with study requirements.
• Monitor, resolve, and facilitate the resolution of data queries, escalating significant issues appropriately.
• Coordinate the shipment and delivery of clinical supplies, including investigational products, laboratory materials, ePRO equipment, and study documentation.
• Train and support site staff on study protocols, systems, study plans, ICH-GCP requirements, and other applicable procedures.
• Act as a primary point of contact for investigative sites, addressing questions and coordinating timely resolution of site-related issues.
• Maintain oversight of study and site integrity while developing effective working relationships with investigators, site staff, sponsors, and internal study teams.
• Monitor site compliance with required training and provide support with access to relevant study systems.
• Track action items, protocol deviations, outstanding issues, and corrective actions through to resolution.
• Coordinate ongoing study communications with investigative sites, ensuring teams receive accurate and timely updates regarding study objectives, regulatory requirements, processes, and project developments.
• Routinely review EDC, IRT, eTMF, CTMS, and other study systems to ensure accuracy, completeness, and compliance.
• Review and maintain Investigator Site Files and Trial Master Files, requesting missing or outstanding documentation when necessary.
• Support document translation, localization, and filing requirements as applicable.
• Participate in study progress meetings, teleconferences, investigator meetings, audits, inspections, and required follow-up activities.
• Support investigator and site selection by conducting and documenting qualification activities and advising on site suitability.
• Lead site activation activities and work with sites to meet study timelines, recruitment objectives, and key milestones.
• Support study start-up and regulatory teams by following up on pending documentation and reviewing or localizing site materials as required.
• Provide guidance to sites to optimize patient recruitment and achieve recruitment milestones.
• Mentor and support CRA I and CRA II team members, including participation in co-monitoring, assessment visits, and visit sign-off activities.
• Provide constructive feedback to junior CRAs and contribute to their professional development.
• Participate in interviews for CRA candidates when requested.
• Contribute to process improvement initiatives, best-practice development, and other internal initiatives.

Requirements:

• 4–6 years of relevant clinical research experience required, with 7–9 years preferred.
• Bachelor’s degree, preferably with Honors, in Health Sciences, Life Sciences, Pharmacy, Nursing, or a related discipline; a Master’s degree is advantageous.
• Relevant Senior CRA and/or ACRP certification or designation is a plus.
• Strong knowledge of ICH-GCP guidelines and applicable local regulatory requirements.
• Experience supporting Phase I–IV clinical trials is preferred.
• Proficiency with clinical research technologies and systems such as EDC platforms, including Medidata Rave or Oracle InForm, as well as IRT, eTMF, CTMS, and Microsoft Office.
• Demonstrated experience independently conducting site monitoring and site management activities across the clinical trial lifecycle.
• Strong understanding of clinical site operations, documentation requirements, data quality, study protocols, and regulatory compliance.
• Excellent interpersonal and communication skills, with the ability to build productive relationships with investigators, site teams, sponsors, and cross-functional stakeholders.
• Strong problem-solving skills and the ability to identify, manage, escalate, and resolve site-level issues effectively.
• Highly organized, detail-oriented, and capable of managing multiple priorities while maintaining a strong sense of urgency.
• Ability to work independently while also contributing effectively within cross-functional study teams.
• Fluent written and spoken English.
• Valid driver’s license.
• Willingness and ability to travel approximately 40–60%, depending on project requirements and site locations.
• Comfortable working from a home-based environment while maintaining strong communication and accountability across distributed teams.

Benefits:

• Salary: $58,000–$96,500 per year, depending on experience, qualifications, location, and other applicable factors.
• Home-based work: Work primarily from a home-based environment.
• Professional growth: Opportunity to expand clinical research expertise across different study phases and therapeutic environments.
• Mentoring opportunities: Develop leadership skills by mentoring and supporting junior CRA professionals.
• Clinical trial exposure: Gain broad experience across site monitoring, study start-up, recruitment, regulatory activities, and study management.
• Cross-functional collaboration: Work closely with sponsors, investigators, regulatory teams, study start-up teams, and other clinical research professionals.
• Meaningful impact: Contribute directly to the quality, compliance, and successful execution of clinical research studies.
• Career development: Participate in process improvement initiatives and contribute to best practices across clinical research operations.
• Travel opportunities: Regular travel provides exposure to diverse clinical sites and study environments.
• Flexible working environment: Home-based role designed to support independent work alongside regular collaboration with distributed teams.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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