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Responsibility
• Be responsible for the delivery of the studies at allocated sites and works
in close collaboration with other CRAs and the local study team to ensure that
quality commitments are achieved in a timely and efficient manner.
• Conduct site feasibility assessment.
• Contribute to the selection of potential investigators and leading
investigator.
• Contribute to national Investigator meeting.
• Obtain and maintain essential documentation in compliance with international
guidelines ICH-GCP, Company procedural documents and local regulations both in
the office and at site.
• Actively participate in local Study Team meetings. Share information on
patient recruitment and study site progress within local Study Team. Good
knowledge in relevant Therapeutic area to train, support and advice Investigators
and site staff in study related matters.
• Initiate monitor and close study sites in compliance with Company procedural
Documents. Ensures compliance with protocols, regulatory requirements,
and good clinical practices; writes follow-up visit reports.
• Drive performance at the sites.
• Update study related systems with data from sites per required timelines.
• Manage study supplies, drug supplies and drug accountability at study sites.
• Perform source data verification. Proactively identify study-related issues
and escalates as appropriate.
• Complete monitoring visit reports within required timelines. Document the
issues and follow up with sites until it is resolved.
• Ensure accurate and timely reporting of Serious Adverse Events.
• Work with data management to ensure quality of the study data. Ensure data
query resolution.
• Prepare for activities associated with audit and regulatory inspection at
responsible sites and/country in liaison with local study team lead and QA.
• Ensure compliance with company policies and procedures relating to people,
finance, technology, security and SHE (Safety, Health and Environment).
• Ability to understand the impact of technology on projects and to use and
develop computer skills while making appropriate use of systems/software
• Responsible for completeness and timeliness of the eTMF to maintain it
“Inspection Ready”.
• Identify and report quality issues along with corrective and preventive
actions to Local study leader/equivalent esp when its related to any data
privacy, serious breaches and/impact to the reputation of company and safeguard
patients’ rights and wellbeing.
Requirements:
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