Clinical Research Associate

Job Description: We are seeking an experienced and detail-oriented Clinical Research Associate to lead and manage clinical trials from initiation through close-out. The CRA will play a critical role in ensuring clinical study integrity, compliance with GCP, and successful execution of study activities across multiple sites. This position requires a strong understanding of regulatory requirements and the ability to work independently in a fast-paced, cross-functional environment.

Qualifications:

• Bachelor's degree in life science/related field, advanced degree preferred
• Minimum of 2+ years in clinical research industry
• Solid understanding of GCP guidelines, regulatory requirements (e.g., Medsafe, TGA), 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:

• 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:

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

Additional Information:

Founded in 2005, KlinEra is a global leader in providing innovative and customized clinical trial services designed to accelerate the delivery of novel therapeutic treatments. With a presence on every major continent and headquarters in Silicon Valley, KlinEra is committed to conducting ethical and efficient clinical trials, enabling faster patient access to groundbreaking therapies. With over 20 years of experience, KlinEra excels in various therapeutic areas, including gastroenterology, oncology, and neurology. Our deep understanding of these fields ensures compliance and supports the successful delivery of clinical trials. In addition to our core business functions, KlinEra is dedicated to giving back to the community through initiatives like KlinEducate, which educates the younger generation about the clinical research industry, and by providing affordable medical care to over 1,200 patients monthly in India. If you can resonate with what KlinEra provides as a company, please join our pipeline.