Riteshkumar Patel Email & Phone Number

Ahmedabad, Gj, In

Ahmedabad, Gujarat, India

Mumbai, Maharashtra, India

• Identify Investigators/ CRO; conduct feasibility & selection visits for site /CRO selection • Preparation, review and compilation of study documents • Ensuring proper compliance of the documents with the regulatory guidelines • Planning and coordination of investigators meetings; preparation and review of IM material • Training to site coordinators • Coordination with the sites and CROs to conduct the study as per the protocol and SOPs • Co-ordination for IMP requirements for study conduct and related documents • Conducting Monitoring visits to ensure study compliance • Timely coordination with Vendors for study requirements • Ensuring timely, accurate, complete collection and submission of study data • Cross functional co-ordination (Project management, regulatory, R&D, QA, Finance and legal) for smooth running of study

Ahmedabad, Gujarat, India

Clinical Research Associate (CT monitor) • Prepare conduct site visits including (but not limited to): qualification visits, initiation visits, monitoring visits and close out visits and according to relevant SOPs, local requirements, the protocol, and project plans as well as providing timely and comprehensive visit and status (i.e., patient recruitment) reports under supervision.• Communication effectively with project team members (i.e., Clinical Team Leader, Project Manager, Safety and Data management) to ensure study completion per company and client requirements and timelines.• Proactively communicate with study sites and follow up on all open issues to meet the project timeline under guidance of the project team, ensure that all study related documentation is tracked, printed and filed as required by SOP, regulatory requirements, and other protocols.• To ensure that investigator site files are assembled appropriately and that all required documentation is in place, tracked and reconciled on a regular basis against the TMF files.

Vadodara, Gujarat, India

Clinical Quality Manager (2017-2019)• Performed quality compliance check of various Clinical Studies by monitoring, auditing and reviewing of study documents (TMF, CRFs, source documents and other related documents) as per study protocol, SOPs and regulatory guidelines. • Performed site initiation, on site study monitoring visits, site close out meetings for outsource studies.• Review of Clinical study Protocol, ICFs and other study documents.• Planning and review of in-house systems for compliance check.• Performed vendor audit and compliance check. • Training coordinator, participate in training program as trainee and trainer and imparting training of SOPs, quality system, Good Clinical Practice etc.• Perform/handle activities as per Quality Management System. (Deviations, Change Controls, CAPAs etc.)• Actively participate in system transfer from paper legacy to software systems like EDMS, LMS, Trackwise etc. • Actively participate in regulatory inspections like US FDA, ANVISA, EMA, DCGI, DCA, WHO etc.• Assisting in drafting and compiling response to QA/regulatory agency, based on queries received form QA/regulatory agency during audit/inspection.• Participate in Quality Review Board meeting and assist to improve trend analysis data presented by QA. Clinical Research Associate (2007-2017)• Performed site initiation, on site study monitoring visits, site close out meetings for outsource studies.• Planning and execute study related activities as per study protocol and regulatory guidelines. • CRFs/eCRFs and study documents creation to capture study activities in compliance with study protocol and regulatory guidelines.• Review of study documents like raw data, CRFs, TMF, medical Records.• Preparation of clinical updates / addendum and submit to EC and sponsor. • AE/SAE reporting to sponsor, EC and regulatory. • Drafting and compiling response to QA based on queries received form QA during audit.

Master'S Degree, Biochemistry

M.Sc., Biochemistry