Philips Sr. Clinical Research Specialist in Shanghai, China
Site Monitoring & Management:
Manage study activities at assigned investigational sites.
Verify the quality of the investigator and the suitability of the sites by performing study feasibility or site evaluation visit to ensure the site is qualified and suitable to conduct the study.
Re involved in the preparation of the documentation for submission to EC.
Ensure the smooth negotiation process on the site contract sign-off. Be responsible for site payment is properly paid according to the agreement.
Perform initiation, regular monitoring and close out visit to investigator site in compliance with study monitoring plan, company SOPs, local regulations and ICH GCP. Prepare and submit accurate and timely site visit reports for all performed visits.
Keep and maintenance the TMF and SRF to ensure it is up to date, complete and accurate according to company SOPs, regulations and ICH GCP.
Verify the accuracy, completeness and legibility of the data collected in the studies;
Ensure all case report forms can be collected and queries can be resolved in timely manner;
Ensure all adverse events occurred in the study be reported in compliance with study as well as regulation requirement;
Verify the trial supply is stored, transferred and tracked appropriately. And unused investigational product and other study supplies is returned or destroyed properly after the completion of study.
Assist in the preparation for the internal or external audit/ inspection. Resolve issues cited in audit reports.
Set up and lead the project team to ensure the study is implemented according to company policy, SOPs and relative regulations.
Prepare the study request form and coordinate the protocol and other study documents development and approval process;
Lead the project team to accomplish the proposed timeline;
Communicate with internal and external business partner in terms of project progress and outstanding issues;
Evaluate the potential investigational sits for a specific study in terms of the qualification of the investigator and the suitability of the sites;
Evaluate the CRO, provide evaluation assessment to line manager;
Actively guide and coach CRAs in the study team;
Coordinate with Data Management, Statistician and Medical Writer to ensure the deliverable on time.
Perform vendor selection and continuous quality and compliance tracking and evaluation;
Perform effective and efficient vendor management to ensure the services vendor provided are satisfied and qualified in compliance with Philips policy, SOP and other related requirements.