Jay Shah
Senior Associate (Clinical Operation) at Excel Life Sciences
- Role
- Senior Associate (Clinical Operation) at Excel Life Sciences Pvt. Ltd
- Location
- Kheda, IN
- LinkedIn followers
- 500 followers
About Jay Shah
Regulatory work ( Submission)- Documentation - Clinical Research…
Experience
Senior Associate (Clinical Operation)
Jun 2014 — Present · Gujarat, IN
Currently working as senior research Associate (Clinical Operation) in Excel life sciences.(June 2014-continue)-Worked in global ophthalmology Phase studies for posterior segment-Worked in global Anterior segment of eye study-Successfully handled sponsor audit for global study- Handled and reported SAE as per the regulatory guideline- Duties carried out during as coordinators are feasibility, site selection, site setup, EC submission, preparation of Regulatory documents, Site SOP, Patient recruitment, Inform consent, and Audio video consent- Management of Sponsor / CRO Submissions• Assisting the investigator in conducting the study as per the standard operating procedures (SOP), regulations and good clinical practice (GCP) guidelines• Reviewing patient data and identify potential patients for the study• Helping the investigator in screening patients• Assisting investigators in the Informed Consent process, coordinating and managing laboratory samples, and ensuring courier and follow-up of lab reports• Maintaining drug accountability and dispensing at the site• Using Interactive Voice Responsive Services (IVRS) for patient’s randomization in randomized studies• Ensuring proper investigational product management, dispensing, temperature monitoring and accountability• Ensuring compliance of project specific schedule of activities• Ensuring compliance of SOPs (both internal and external, as applicable)• Preparing, attending and following-up monitoring visits and resolving queries within a stipulated timeline• Completing eCRF entry and source document with minimal error• Preparation, attendance and follow-up of audit and audit reports• Trial closeout: preparation, attendance and follow-up; forwarding the necessary information of site closeout• Verifying the accuracy and validity of data entered in databases; correcting any errors• Managing the reports, trackers regarding the progress of a study
Skills
- Gcp
- New Site Development
- Sop
- Relationship Development
- Clinical Research
- Anda
- Ich-Gcp
- Pharmacovigilance
- Pharmacology
- Dissolution
- Regulatory Requirements
- Usp
- Pharmaceutical Industry
- Formulation
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