Responsibilities:

• Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.
• Review completion of proper informed consent procedures.
• Ensure accurate data reporting via review of site source documents and medical records.
• Interpret data to identify protocol deviations and risks to subject safety/data integrity.
• Generate queries and manage resolutions with site personnel.
• Perform investigational product accountability as per the protocol and Study Monitoring Plan.
• Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.
• Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.
• Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required.
• Act as primary liaison with study site personnel.
• Enter data into tracking systems as required.
• Participate in the identification and selection of investigators and clinical sites.
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.
• Provide clinical and technical support for project team as required.
• May interact with representatives of client affiliates as per project requirements.

Qualifications and Requirements (degree, certifications, etc. and other requirements):

• B.Sc.. in a field relevant to clinical research, nursing degree and/or equivalent experience;
• M. Sc. In a field relevant to clinical research, nursing degree is an asset;
• Good knowledge of ICH/GCP standards and applicable regulatory requirements;
• At least 5 years of years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry;
• Ability to prioritize different assignments and work under pressure while maintaining attention to detail, accuracy in work, and meeting timelines;
• Excellent judgement and problem-solving skills;
• Strong organizational, communication, time management and multi-tasking skills;
• Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint).

上班地址：上海张江哈雷路866号