Pallavi Panth, Md (Mbbs), Phd Email & Phone Number

Frisco, Tx, Us

Public Health Nutrition

Systematic Reviews, Biomed Central

Biological Trace Element Research

Biological Trace Element Research

• Clinical monitoring support of investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. • Medical Science Liaison Collaboration Initiative Lead for South US between Amgen FSP and CRO partners. • Review and assistance with submission of AEs, SAEs in accordance with CSR guidelines and per SOPs and FSP requirements.• Ensuring data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities and assessing investigational product through inventory and records review. • Participating in investigator meetings, identifying potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. • Initiating clinical trial sites according to the SOPs to ensure compliance with the protocol and regulatory and ICH GCP obligations, performing trial close out and retrieval of trial materials.• Ensuring that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducting on-site file reviews as per project specifications.• Providing trial status tracking and progress update reports to the team per agreed study conventions in Clinical Trial Management Systems.• Facilitating effective communication between investigative sites, client company and internal project teams through written, oral, and/or electronic contacts, and assisting company, client, and applicable regulatory requirements/audits/inspections.• Mentoring, coaching and performance evaluation of CRAs in training during Onboarding per SOPs.

Denton, Tx

• Planned and executed several didactic lectures to graduate and undergraduate students on advanced and basic biochemistry, metabolic processes, and techniques utilized in endocrine, metabolic disease, and micronutrient research.• Designed and spearheaded discussion-based problem solving and literature review sessions utilizing recently published research.• Taught, and advised graduate and undergraduate students from Nursing, Occupational Therapy, Physical Therapy, Kinesiology, Psychology, and Nutrition programs.• Instructed specific coursework in nutritional biochemistry, nutrition planning, and chronic disease prevention, such as Nutrition and Metabolic Syndrome, Nutrition and Human Metabolism, Advanced Macronutrients and Micronutrients, Introduction to Nutrition, Bio-Nutrition, Nutrition through the Lifecycle, Community Nutrition, and Food and Culture.• Prepared, tracked, and submitted grant applications, budgets, IRB submissions, informed consent forms, study protocols, and lab safety and regulatory materials.

Department Of Nutrition And Food Sciences, Denton, Tx

• Therapeutic Area: Endocrinology and Metabolic Diseases • Dissertation Research: Iodine supplementation and its effects on iodine status, thyroid function, body composition and resting metabolic rate in reproductive-age women.• Developed research initiatives and protocols and trained new graduate and undergraduate students entering the laboratory.• Prepared, tracked, and submitted grant applications, budgets, IRB submissions, informed consent forms, study protocols, and lab safety and regulatory materials. • Screened reproductive-age women via 24-hour urinary iodine, salivary iodine, and sodium-iodide symporter testing for iodine status determination for inclusion-exclusion into iodine supplementation research trial.• Assessed body composition using Dual Energy X-Ray Absorptiometry (DXA), General Electric, and assessment of resting metabolic rate and ParvoMedics Metabolic Cart testing for iodine supplementation trial.• Randomized participants into double-blind, placebo-controlled, randomized-controlled, six-month, iodine supplementation research trial.• Analyzed serum samples for Thyroid Stimulating Hormone, thyroid hormones (T3 and T4), and thyroid antibodies (thyroid peroxidase and thyroglobulin), using Enzyme Linked Immunosorbent Assay (ELISA) techniques.• Used Microsoft Excel, EndNote, and RefWorks referencing software and SPSS statistical package for data preparation, analysis, and manuscript submissions.• Participated-in and led weekly journal clubs to review and critique scientific publications and project update presentations.

Student Health Services, Denton, Tx

• Managed Immunization Online Student Portal and Student Information System integration.• Managed electronic patient management systems for scheduling, patient data, and billing and insurance, in compliance with HIPAA regulations.• Created patient handouts, insurance brochures, and medical record logs to assist with Student Outreach.• Planned and conducted annual university health fairs, Pink Promises walks, tobacco awareness clinics, safe sex clinics, and immunization clinics for Peer Advocates teaching Health (PATH), Health Promotion programs. • Assisted in EHR transitioning from Neusoft and Medicat Medical software programs.

Department Of Nutrition And Food Sciences, Denton, Tx

• Managed graduate and undergraduate students conducting thesis and undergraduate research at the Institute for Women’s Health Clinic for the Department of Nutrition and Food Sciences.• Screened post-menopausal females for induction into a randomized-controlled, four-month, Raspberry Osteopenia Study via Lumbar DXAs, post-inclusion DXA scans of left femur, left forearm, and total body at baseline and in six months.• Screened pre-m menopausal females into a randomized-controlled, two-week, Tart Cherry Study via body composition scans using total body DXA scans.• Screened post-menopausal females into a randomized-controlled, three-month, Blueberry Osteopenia Study using lumbar and femoral DXA scans.• Conducted clinical analysis of DXA reports and classification of results for statistical analysis and manuscript submission.• Performed In-vitro and In-vivo research, phlebotomy, serum and plasma sample preparation for transport and storage, ELISAs, and Protein Assays.• Mentored undergraduate students, explained background materials, and demonstrated the use laboratory equipment such as DXA, Parvo Medics Medical Cart, and laboratory techniques such as enzyme-linked immunosorbent assays (ELISA), blood sampling, spectrophotometry, protein determinations, and anthropometric assessments.• Designed and taught sections of courses in conjunction with the instructor to graduate and undergraduate students in topics covering the fundamental principles of nutritional biochemistry, nutrition and human metabolism, advanced nutrition laboratory principles.• Instructed courses, such as Human Metabolism, BioNutrition, Community Nutrition, Advanced Macronutrients, Research Methods, Advanced Nutrition Laboratory Methods.• Designed and taught sections of courses in conjunction with the instructor to graduate and undergraduate students in topics covering the fundamental principles of nutritional biochemistry, nutrition and human metabolism, advanced nutrition laboratory principles.

Dallas/Fort Worth Area

• Therapeutic Areas: Phase II, III and IV, Oncology, Non-alcoholic steatohepatitis (NASH), Infectious Disease, Medical Device • Clinical monitoring of investigator sites for various sponsors under the full-service model.• Assisted with peer- review, development, and submission of trial related documents such as ICFs, monitoring plans and regulatory documents per SOPs and ICH-GCP guidelines. • Conducted qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol, and regulatory document review.• Verified investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff, medical record, and research source documentation verification against case report form data, • Ensured adherence to good documentation practices and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.• Verified and reviewed AEs, SAEs, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.• Assessed clinical research site’s patient recruitment and retention success, and completion of monitoring reports and follow-up letters, including providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.• Mentored and trained new Clinical Research Associates.

Mesquite, Tx

• Therapeutic Areas: Phase, II, III and IV, Cardiovascular and Metabolic Diseases, Endocrinology, Diabetes Mellitus, Rare Diseases (Acromegaly)• Industry sponsors: Sanofi, Eli Lilly, Amgen, BMS, Novo Nordisk, Merck • Managed Phase II, III, and IV clinical research trials, primarily in the areas of Endocrine and Metabolic diseases, such as Diabetes, Metabolic Syndrome, Obesity, and Cardiovascular diseases.• Coordinated regulatory affairs and approvals between the Sponsor and Principal Investigator (PI).• Planned, coordinated, and implemented patient screening, recruitment/participant study activities, and data collection and records management related to assigned clinical trial protocols.• Implemented guidelines, clinical trial management, and Institutional Review Board (IRB), International Conference on Harmonization-Good Clinical Practice (ICH-GCP), Food and Drug Administration, and Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations and practices.• Served as liaison between patients, the medical team, Clinical Research Associates (CRA), Central IRB, Sponsors, MSLs, and PIs.• Provided ongoing informed consent in collaboration with the PI and Sub-Investigator by presenting all essential elements of consent to research subjects.• Developed effective rapport with participants and their families to ensure optimal participant compliance, retention, and satisfaction.• Assisted in management of patient care, maintaining careful adherence to regulatory and Sponsor-mandated guidelines.• Maintained availability for Sponsor monitors or other auditors to discuss study issues.• Participated, as required, on site audits and corrective actions of internal audits, internal compliance audits, Sponsor monitoring visits or audits, or other governmental audits.• Development of site SOPs necessary to train individuals involved in the conduct of the study in accordance with protocol and ICH-GCP guidelines.

Doctor Of Philosophy - Phd, Nutrition Sciences

Activities and Societies: Phi Kappa Phi, Golden Key International Honor Society, Epsilon Omega Epsilon, National Society of Leadership.

M.S, Clinical Nutrition/Nutritionist, 3.93

Activities and Societies: Phi Kappa Phi, Golden Key International Honor Society

Bachelor Of Medicine, Bachelor Of Surgery - Mbbs, 4.0