Participates in site feasibility and / or pre-trial site assessment visits, providing recommendation from local area about site / investigator selection in collaboration with the trial team
Acts as primary local company contact for assigned sites for specific trials.
Attends / participates in investigator meetings as needed.
Responsible for executing activities within site initiation and start-up, site monitoring, site management and site / study close-
out according to internal SOPs / WIs / IFUs and policies.
Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
Ensures that all AEs / SAEs / PQCs are reported within the required reporting timelines and documented as appropriate.
For AEs / SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF / IF, Trial Master Source and Sharepoints). Profile :
A minimum of a BA / BS degree is required. A degree in a health or science related field is preferred.
Must have experience in Clinical Research or equivalent qualification
Usually 0-2 years' experience monitoring on site
Specific therapeutic area experience may be required depending on the position.
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated 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.