Senior Clinical Research Associate

Requirements

• Bachelors or Masters Degree or University Degree or equivalent.
• At least 3 years CRA working experience in multinational pharmaceutical, Medical Device company or CRO.
• Have Medical Device or IVD clinical trials experience.
• Familiar with clinical trial Quality Management System.
• Good English skills, willing to learn, hard working.
• Candidate should be major in clinical medicine or pharmacy; Pathology would be a plus.
• 10% domestic travel.
• Additional Details
• This job has a full time weekly schedule.
• Travel Required:
• 10% of the Time
• Shift:
• Day
• Duration:
• No End Date
• Job Function:
• Medical/Clinical

Additional Information

Job Description Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan. Ensures the HGRAC and IRB submission and approval. Ensures assigned sites are conducting studies according to protocol requirements and applicable regulations and guidelines. Ensure that the rights and wellbeing of human subjects are protected. Ensure the trial data are accurate, complete, and verifiable from source documents. Verifies that the investigator is enrolling only eligible subjects. Performs verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data. Ensures that any corrections are appropriately documented by authorized site staff. Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records. Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period. Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence. Delivers quality written reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans. Ensure that the trial is conducted and documented properly from study start-up through close-out. Participates in site audits, as requested. May conduct site and study feasibility assessments. May be involved in the development of monitoring guideline and tools. Support study monitoring from other BU as needed.

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Company Intel

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