Role & responsibilities :
- Prepare and send EC and SIV dossier to site as per instructions from COM/CPM/CRA and
instructions outline in SOPs. - Dispatch clinical trial supplies to respective sites for ongoing studies as per the requirement.
- Coordinate with study sites for ongoing studies as per the need.
- Assist CRAs to update in-house files and perform quality review of in-house files as define in
the study plans and convey the outcome to the CRAs. - Maintain and update the study trackers (for.e.g. Study documents, Finance, Study equipment
etc.) as per define frequency. - Review invoices received from respective sites in a timely manner and convey the outcome
to respective CRA and site team as applicable. - Provide in-house support to CRAs for ongoing studies
- Prepare minutes of meetings for Important study related discussion as instructed by
COM/CPM. - Assist training coordinator to coordinate departmental training as per the training calendar.
- Complete other assigned activities per the need of the study and Organization.
Preferred candidate profile :
- Thorough understanding of ICH-GCP
- Good communication skills
- Ability to work under pressure
- Multi-tasking ability
- Ability to work independently Eye for detail
- 2-3 years of experience in Pharma/Biotech/CROs in Clinical Research would be preferred.