About the Company

KlinEra Global Services is a global Clinical Research Organization (CRO) providing comprehensive clinical research and development services to pharmaceutical, biotechnology, and healthcare organizations. We are committed to delivering high-quality clinical research solutions while maintaining the highest standards of scientific integrity, patient safety, regulatory compliance, and operational excellence. We are seeking an experienced and motivated Senior Clinical Research Associate (Senior CRA) to join our growing Clinical Operations team.

This position is preferably based in Sydney, Australia, although highly qualified candidates located in Auckland, New Zealand will also be considered.

The successful candidate will play a key role in managing multiple clinical trials while ensuring studies are conducted in compliance with applicable regulations, Good Clinical Practice (ICH-GCP), sponsor requirements, and company Standard Operating Procedures (SOPs).

Job Summary The Senior Clinical Research Associate will be responsible for leading and managing multiple clinical studies from study start-up through close-out while ensuring study quality, subject safety, protocol compliance, and timely project delivery. The role requires close collaboration with sponsors, investigative sites, and cross-functional teams including Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, and Medical Writing. The successful candidate will serve as a key point of contact for assigned studies while providing mentorship and support to junior CRAs when needed.

Key Responsibilities Lead and manage multiple clinical trials from initiation through close-out, ensuring adherence to study protocols, timelines, budgets, and quality standards.

Develop, maintain, and update study tracking documents, including subject tracking logs, essential document trackers, and sample collection/management trackers.

Conduct site qualification, initiation, routine monitoring, and close-out visits as required, ensuring compliance with ICH-GCP, study protocols, applicable regulations, and company SOPs.

Review, collect,



and track regulatory documentation from investigative sites and ensure timely filing of essential documents within the Trial Master File (TMF).

Perform source data verification (SDV), data review, and query resolution to ensure the integrity, completeness, and accuracy of clinical trial data.

Coordinate and monitor clinical laboratory samples, central laboratory activities, and sample shipment reconciliation.

Collaborate with Regulatory Affairs to ensure study documentation is complete and submitted according to study timelines and regulatory requirements.

Identify study risks and proactively implement mitigation strategies to support successful study execution.

Provide guidance, coaching, and mentorship to junior Clinical Research Associates and investigative site personnel regarding study protocols, GCP requirements, and clinical trial procedures.

Maintain effective communication with investigators, site personnel, sponsors, vendors, and internal cross-functional teams.

Prepare accurate monitoring visit reports and ensure timely follow-up on outstanding site action items.

Support sponsor audits, regulatory inspections, and internal quality assurance activities.

Assist with feasibility assessments, site selection, and study start-up activities when required.

Travel to investigative sites as needed to support monitoring activities and study oversight.

Required Qualifications & Experience Bachelor's degree in Life Sciences or a related scientific discipline; an advanced degree is preferred.

Minimum of 5+ years of experience within the clinical research industry, preferably within a CRO, pharmaceutical, biotechnology, or medical device setting.

Strong understanding of ICH-GCP guidelines, clinical trial processes,



and applicable regulatory requirements including FDA, EMA, Medsafe and TGA.

Demonstrated experience independently managing multiple clinical studies across various phases.

Experience conducting on-site and remote monitoring visits, including Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs).

Experience managing Trial Master Files (TMF), regulatory documentation, and clinical study records.

Ability to work independently with minimal supervision while effectively managing competing priorities.

Willingness and ability to travel as required.

Skills & Competencies Excellent organizational and project management skills with exceptional attention to detail.

Strong analytical and problem-solving abilities.

Outstanding written, verbal, and interpersonal communication skills.

Strong collaboration skills with the ability to work effectively within cross-functional and multicultural teams.

Ability to thrive in a fast-paced, dynamic clinical research environment.

Strong time management skills and ability to manage multiple studies simultaneously.

High level of professionalism, accountability, and integrity.

Proficiency in Microsoft Office Suite, Electronic Data Capture (EDC) systems, CTMS, and eTMF platforms.

What We

Offer

Opportunity to work with a growing global Clinical Research Organization.

Exposure to international clinical research projects and global sponsors.

Collaborative and inclusive working environment.

Opportunities for professional growth and career advancement.

Competitive remuneration package commensurate with qualifications and experience.

Opportunity to contribute to innovative clinical research that improves patient outcomes. How to Apply

If you are an experienced Clinical Research Associate looking to advance your career while contributing to high-quality clinical research across Australia and New Zealand, we would love to hear from you. Please submit your updated CV/Resume along with a brief cover letter outlining your relevant experience and suitability for the position.

📌 Senior Clinical Research Associate (Sydney)
🏢 KlinEra Global Services
📍 Sydney