1+ years of professional experience, knows fundamental concepts, practices and procedures of particular field of specialization.
Roles & Responsibilities:
To ensure efficiency and consistency of the study start up process in compliance with estab-lished internal (local/global) procedures, ICH GCP and local regulations, while maintaining swift timelines from Final Protocol Package (FPP) release to site initiation. In addition, to ensure in-house processes including Investigator Notification distribution, track-ing of timelines and essential documents are well managed in accordance with applicable SOP / working procedures.
• In collaboration with the MA / CRA Manager / Lead CRA, participate in the feasibility meetings, design & implement feasibility questionnaires and assess suitability of trial & sites upon receipt of responses
• Liaise with clinical teams to obtain all documents associated with country specific FPP.
• Prepare / review the localized Patient Information and Consent Forms from Global templates ensuring compliance with ICH GCP and local regulatory requirements; obtaining translations as required
• Track submissions and status of start-up activities for all trials.
1. Demonstrates ability to coordinate, organize and communicate
2. Basic understanding of clinical development pro-cess including GCP and ICH fundamentals
3. Proven ability to work on teams and deliver on commitments
4. Computer literacy 5. Level of proficiency in adequacy with CRA I competency profile.
• At least 1 year(s) of working experience in the related field is required for this position.