Senior Clinical Research Associate in Sydney

KlinEra Global Services Pty Ltd – Sydney CBD NSW

Bachelor's degree in life science/related field, advanced degree preferred.

Minimum of 5+ years in clinical research industry.

Solid understanding of GCP guidelines, regulatory requirements (e.g., TGA, FDA, EMA), and clinical trial processes.

Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams.

Detail-oriented with ability to work in a fast-changing environment.

Excellent interpersonal, oral, and written communication skills.

Superior organizational skills with attention to details.

Ability to work with little or no supervision.

Responsibilities

• Lead and manage multiple clinical trials from initiation to close-out, ensuring adherence to study protocols, timelines, and budgets.
• Develop and update multiple study tracking documents: subject tracking, essential document tracking, and sample collection/management.
• Conduct site visits to monitor study progress, evaluate data quality, and ensure compliance with Good Clinical Practice (GCP) when needed.
• Gather, track and review for completeness site regulatory documents for TMF filing.
• Perform data verification and query resolution to ensure the integrity and accuracy of clinical data.
• Facilitate in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation.
• Provide guidance and training to junior CRAs and site staff on study protocols and procedures.
• Collaborate with regulatory affairs to ensure all necessary documentation is in place and submitted according to timelines.
• Work closely with cross-functional teams, including clinical operations, data management, and biostatistics, to facilitate effective communication and problem-solving.
• Identify potential issues and implement strategies to mitigate risks associated with study execution.
• Ability to travel.

Skills

• Strong attention to detail
• Good written and verbal communication
• Organized and able to manage multiple tasks
• Reliable and self-motivated
• Able to work independently or in a team
• Friendly and professional with clinical site staff

What We Offer

• Opportunity to work on cutting-edge projects and make a significant impact
• Supportive and dynamic work environment
• Professional development and growth opportunities

About Our Company

Established in 2005, KlinEra provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that will accelerate delivery of novel therapeutic treatments with faster patient access. KlinEra has extensive experience in a diverse number of therapeutic areas for the last two decades. Thorough understanding of specific therapeutic area ensures compliance and facilitates optimal delivery. Our unsurpassed network of Key Opinion Leaders and established relationship with Investigators enables expedited enrollment and quality results, also we have maintained very high regulatory standards which helped us successfully accomplish multiple global projects.