• Same role as Virtual Clinical Trials Study Assistant / Study Concierge • Provide clinical research support to virtual site investigators to prepare for and execute assigned research studies, including:• Review and become proficient with virtual study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to collect and record clinical research data;• May collect and submit regulatory/ethics documentation as required by the… Show more • Same role as Virtual Clinical Trials Study Assistant / Study Concierge • Provide clinical research support to virtual site investigators to prepare for and execute assigned research studies, including:• Review and become proficient with virtual study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to collect and record clinical research data;• May collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research;• Maintain subject screening logs;• Develop tracking logs and maintain source documentation based on protocol requirements;• Assist with the scheduling of virtual study visits in conjunction with Virtual Study Coordinator and the virtual site;• Collect, record, and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness;• Correspond with virtual research subjects and troubleshoot study-related questions or issues;• Assist Virtual Study Coordinators with gathering responses and communicating with virtual study participants• Assist with study data quality checks and query resolution.• Assist virtual investigator and site staff in verifying that research study objectives are met on time and according to applicable protocol requirements, clinical research regulations and quality standards.• Provide training to new investigator site staff members on study-specific systems/platforms and requirements.• Assist virtual investigator and site staff with training requirements for compliance and documentation of such trainings.• Assist with other regulatory compliance documentation collection as needed• Assist research site with coverage planning related to staffing and scheduling for research projects.• Attend all relevant study meetings;• Prepare and send study-related documents and materials to virtual sites Show less

·Helped acquire the largest client of Labcorp pharmacovigilance contact center by demonstrating the case triage and intake process during the client audit (pre-contract signing).

• Provided technical and medical information with high-quality customer service, including researching and responding to inquiries received via phone, email, internet or mail.• Ensured that relevant information such as but not limited to patient contact details, medical history, concomitant medications and etc. were collected for completeness of the report - Adverse Events (AE/SAE), Product Quality Complaints and combination cases.• Reconciled cases which were processed, entered, and… Show more • Provided technical and medical information with high-quality customer service, including researching and responding to inquiries received via phone, email, internet or mail.• Ensured that relevant information such as but not limited to patient contact details, medical history, concomitant medications and etc. were collected for completeness of the report - Adverse Events (AE/SAE), Product Quality Complaints and combination cases.• Reconciled cases which were processed, entered, and referred for peer review. Monitored cases that were open until case closure.• Escalated medical or technical inquiries to Project Coordinator and Team lead if no response available in the approved Standard Response Letter, FAQs and Product Information. • Ensured completion all org level and project-specific trainings in LMS • Ensured that project specific service level agreement was attained • Made sure that cases were sent to the responsible group within the agreed timeline • Practiced First-time Right concept in every case processed to promote a high-level quality reporting• Performed any other support activities as assigned. Show less

• Identified and documented fraudulent or erroneous activities committed by network pharmacies in the US. • Analyzed and monitored prescription claims against fraud, waste and abuse related to network pharmacies. • Investigated, reviewed and analyzed data of prescription claims while applying the knowledge of pharmacy policy. • Practiced data mining techniques to determine the details of fraudulent, erroneous, or abusive billing activity on Real Time Application System and various… Show more • Identified and documented fraudulent or erroneous activities committed by network pharmacies in the US. • Analyzed and monitored prescription claims against fraud, waste and abuse related to network pharmacies. • Investigated, reviewed and analyzed data of prescription claims while applying the knowledge of pharmacy policy. • Practiced data mining techniques to determine the details of fraudulent, erroneous, or abusive billing activity on Real Time Application System and various reports. Show less

• Responsible for safety, efficacy, pharmaceutical elegance and other properties of the products marketed.• Coordinated with the suppliers/manufacturer and warehousing, and kept records of all products.• Provided accurate drug information and patient counselling to help patient on product selection and effective use of medication.• Dispensed prescription medications and kept the Rx book records updated.• Complied with FDA requirements and all regulatory mandates concerning… Show more • Responsible for safety, efficacy, pharmaceutical elegance and other properties of the products marketed.• Coordinated with the suppliers/manufacturer and warehousing, and kept records of all products.• Provided accurate drug information and patient counselling to help patient on product selection and effective use of medication.• Dispensed prescription medications and kept the Rx book records updated.• Complied with FDA requirements and all regulatory mandates concerning pharmacy operations, pharmaceutical products and medical devices being catered. Show less

·Assured the quality of veterinary products being catered, throughout the manufacturing process starting from raw materials to market distribution.·Managed the workforce of 5-10 staff members and supervised the production operations.