Shweta Nagar

● Coordinated clinical trials with HIPAA and CFR 21 compliance

● Organized study related meetings and took meeting minutes

● Reported AEs (Adverse Events) and SAEs (Serious Adverse Events) and administered Informed Consents

● Conducted clinical trials as specified by the study protocol

● Prepared study documentation according to protocols

● Performed screening and enrollment of test subjects

● Maintained quality conformance as per the requirements of Eurofins CRL Inc. SOP (Standard Operating Procedure), GCP (Good Clinical Practices) and ICH (International Council for Harmonization) guidelines

● Worked with various stakeholders to define requirements for study protocol

● Validated data entry of source documents and/or transfer of data to Case Report Forms (CRFs)

● Collected medical history information, eligibility criteria from subject pool

● Worked with measuring devices common to clinical efficacy studies

● Recorded and captured data, validated data entry of source documents and transferred data to CRFs

● Performed specialized procedures as qualified by training and evaluating proficiency

● Reviewed documentation and study folders prior to departmental release to QA or archiving

● Coordinated, organized, and maintained all study documentation including source documentation, CRFs, and study, regulatory and patient binders

● Prepared and processed all documentation through the Institutional Review Board (IRB), including submissions, continuing reviews, amendments, and adverse event reporting

● Prepared and participated in audits conducted by sponsors and other oversight entities

● Worked to improve processes to achieve greater customer satisfaction

● Coordinated appropriate and timely payments to participants ensuring sustained enrollments

• Used cognitive behavior therapy to assist clients in recognizing and redirecting poor habits.
• Guided clients in developing skills and strategies for dealing with problems.
• Implemented evidence-based therapeutic interventions to promote positive behavior change.
• Developed individualized counseling plans for clients to incorporate short-term and long-term goals.
• Conducted assessments to determine progress and performance and report findings to relevant authorities.

• Conducted assessments to determine progress and performance and report findings to relevant authorities.
• Developed individualized counseling plans for clients to incorporate short-term and long-term goals.
• Assessed clients' needs to provide appropriate therapeutic interventions.
• Listened to clients' concerns and provided encouragement and support.

• Oversaw studies, documented data, and extrapolated results.
• Generated high-quality, professional papers for submission to scientific publications.
• Performed chemical analysis of various underutilized foods.
• Conducted classes (theory & practical) of BSc (Group Home Science) students on Biochemistry. Development of entrepreneurial skills in village women.