Base on Beijing
1. Participates in site feasibility and/or pre-trial site assessmentvisits, providing recommendation from local area about site/investigatorselection in collaboration with the trial team
2. Acts as primary local company contact for assigned sites for specifictrials.
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing activities within site initiation andstart-up, site monitoring, site management and site/study close-outaccording to internal SOPs/WIs/IFUs and policies.
5. Ensures site staff are trained and the corresponding training recordsare complete and accurate at any time point during all trial phases.
6. Contributes to site level recruitment strategy and contingencyplanning and implementation in partnership with other functional areasto achieve clinical research target.
7. Ensures site study supplies (such as Non-IP, lab kits, etc.) areadequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used, handledand stored and returns are accurately inventoried and documented.
9. Arranges for the appropriate destruction of clinical supplies
10. Ensures site staff complete the data entry and resolve querieswithin expected timelines.
11. Ensures accuracy, validity and completeness of data collected attrial sites
Ensures that all AEs/SAEs/PQCs are reported within the requiredreporting timelines and documented as appropriate. For AEs/SAEs, ensuresthat they are consistent with all data collected and with theinformation in the source documents.
EDUCATION AND EXPERIENCE REQUIREMENTS:
A minimum of a BA/BS degree is required. A degree in a health or sciencerelated field is preferred.
A minimum of 3 years of clinical trialmonitoring experience ispreferred.
Specific therapeutic area experience may be required depending on theposition.
Strong working knowledge of ICH-GCP, company standard operatingprocedures, local laws and regulations, assigned protocols andassociated protocol specific procedures including monitoring guidelines.
Strong IT skills in appropriate software and company systems.Willingness to travel with occasional overnight stay away from home.
Proficient in speaking and writing the country language and English.Good written and oral communication skills.