Khush Raval Email & Phone Number

Ahmedabad, Gj, In

Ahmedabad

• Ensuring the quality of the trial data and rights, safety & wellbeing of subjects are not compromised.• Review of clinical trial data i.e. Inform Consent Documents (ICD), Case Report Forms (CRF), Source Documents, IP related documents and site investigator file (SIF). Also, ensuring GCP & GDP (ALCOA) compliance. • Identifying the Observations, issues, Deviations that observed during monitoring visits and working with the study team to resolve appropriately and provide guidance to study/site team to avoid such errors in future. • Coordinating regularly with study/site team, including investigators and PM/CTL to ensure that all parties are aware of observations, issues, deviation and working together.• Review of PK studies data and provide appropriate training/Guidance to the study/site team to Ensuring that all PK related data is Protocol & GDP (ALCOA) compliant.• Ensure to follow and adherence of organization general rules, policies and applicable Standard Operating Procedures. • Responsible for conducting in-process audits (for activities like IP receipt, storage, shipment, destruction etc., PK Sample receipt, shipment etc.).• Sourcing and recruiting contractual phlebotomist for Cliantha sites and track attendance on monthly basis or as and when require. • Prepare the primary Agreement & workorder/Amendments for phlebotomist & communicate with Legal & HR team.• Provide training and support to phlebotomist personnel on study methodology and PK sample management. • Ensuring that all PK samples related data from site will be received and reviewed periodically in accordance with Protocol/sample management plan/SOPs and applicable regulatory guidelines.• Regular Coordination with onsite phlebotomist regarding all patient centric activity for PK samples management.• Prepare & Maintain PK sample related tracker regularly.• Identifying the PK related Observations, issues, Deviations that observed and working with the study team to resolve appropriately.

Ahmedabad, Gujarat, India

Coordination with pharmaceutical companies / CRO monitors• Assist in administering informed consent with patient. • Assisting Principle Investigator in Subject recruitment by helping in advertisement to achieve the recruitment in given timeline.• Patient care by proper follow-up with the central as well as local lab to get the lab reports on time. • Management and reporting of AE/SAE to EC • Completing Paper CRF and forward to Data management.• Attended Study close visit . The activities performed during study close out visit were reconciliation of investigational product, tracking of investigator’s payment, completing the filing of Investigators site file, archival of study documents, tracking of airway bill for blood samples sent to central laboratory.• Communication with Ethics Committee for getting approval for the new study and also arranging minutes of meeting for Ethics Members.• Complete Data Clarification Forms and send it to Sponsor / CRO. • Co-ordinate PSV, SIV, monitoring as well as audit visits at site.• Maintain study related logs- screening, enrollment, drug administration ,temperature, phone contact logs/forms.• Ensure adequate and appropriate use of IVRS.• Maintain clinical Trial supplies and arrange adequate supplies.• Maintain adequate supplies of investigational product/test article.

Ahmedabad, Gujarat, India