Senior Clinical Research Associate - KlinEra Global Services Inc

Qualifications 

• 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., 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.