What are the responsibilities and job description for the Senior Clinical Research Associate position at 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.
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