Senior Clinical Research Associate

KlinEra Global Services Pty Ltd; Sydney; Vor Ort; AUD 100.000 - 140.000; Vollzeit

Benefits dieser Stelle

Professional development opportunities

Dynamic cross-cultural environment

Travel-friendly role

Zusammenfassung

KlinEra Global Services Pty Ltd – Sydney CBD NSW is seeking an experienced clinical research professional to lead and manage multiple trials from initiation through close-out. You will develop tracking documents, monitor site progress, ensure data integrity, and collaborate with regulatory affairs.

The ideal candidate has a life-science degree with 5+ years in clinical research, strong GCP knowledge, and excellent communication.

Qualifikationen

• Bachelor’s degree in life science or related field.
• Minimum of 5+ years in clinical research.
• Solid understanding of GCP guidelines and regulatory requirements (TGA, FDA, EMA).
• Experience working in cross-functional and multi-cultural teams.
• Excellent interpersonal, oral, and written communication skills.

Aufgaben

• Lead and manage multiple clinical trials from initiation to close-out.
• Develop and update study tracking documents (subject tracking, essential documents, sample management).
• Conduct site visits to monitor progress and data quality.
• Gather and review site regulatory documents for TMF filing.
• Perform data verification and query resolution for data integrity.
• Track clinical lab samples and central reader/lab data and sample shipments.
• Provide guidance to junior CRAs and site staff on study protocols.
• Collaborate with regulatory affairs to ensure documentation timelines are met.
• Work with cross-functional teams to solve problems and mitigate risks.
• Ability to travel as required.

Kenntnisse

Attention to detail

Written communication

Verbal communication

Organized

Independent or team player

Professional with site staff

Ausbildung

Bachelor’s degree in life science

Advanced degree preferred

Jobbeschreibung

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.

Detailed 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.

Perform data verification and query resolution to ensure the integrity and accuracy of clinical data.

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 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.