Clinical Research Monitor

VISHALKUMAR PATEL, MD

678-***-**** adhj4g@r.postjobfree.com JEFFERSON, GA 30549

Dedicated Medical Doctor with 6+ years of clinical healthcare experience and a highly trained clinical research professional. Managing multiple Hem/Oncology studies at NCI designated Winship Cancer Institute Atlanta, Ga to improve the quality of lives of patients. Extensive knowledge and training in conducting and monitoring clinical trials, ICH Good clinical practice, data management, regulatory affairs and clinical development. In depth knowledge of ICSR processing, signal detection, safety communications, aggregate reporting and risk management plans. Effective scientific communicator with ability to make complex scientific concepts accessible to audiences of various backgrounds. Well versed in building strong working relationships with patients, KOLs and HCPs. Highly adaptive and self-motivated individual with a unique combination of detail-oriented mindset, driven and competitive personality and proven ability to meet tight deadlines by working in a fast-paced work environment.

SKILLS

ICH Good Clinical Practice E6(R2) and GPvP

Good Documentation Practice following ALCOA-C

Phase I-IV drug development

Patient care and clinical consulting

Data management and data analysis

Execution of clinical trial protocols and SOPs

Regulatory submission and compliance

Medical writing and literature review

Knowledge of FDA and EMA regulations

Critical thinking and problem-solving skills

Preclinical and clinical data interpretations

Excellent communication and presentation skills

Proficient in multiple TMF and EDC applications

Leadership abilities to train & manage staffs

Recruitment, retention, monitoring and CAPA

KOL engagement and development

Knowledge of Oracle Argus and MedDRA coding.

Experience in multiple therapeutic areas including Internal Medicine, Hem/Oncology, Nephrology, Cardiology

PROFESSIONAL EXPERIENCES/TRAINING

Emory Winship Cancer Institute -Atlanta, Ga 01/2020 - Present

Clinical Research Monitor - Hem/Oncology

Working collaboratively with Key Opinion Leaders (KOLs), research managers, and sponsors to conduct and monitor activities associated with Hem/Oncology research trials for Multiple Myeloma, MDS and Leukemia.

Interacting extensively with sponsors and Investigator Physicians to discuss safety concerns for subjects pertaining to research trials and investigational products. Reviewing eligibility packets to verify all inclusion and exclusion criteria are met to prevent protocol deviations.

Monitoring study visits and procedures to ensure continued compliance with protocol, SOPs and ICH GCP guidelines, assessing AEs and SAEs according to NCI CTCAE grading (LLT form of MedDRA) into the database system, writing case narratives, and communicating with regulatory agencies and sponsors in a timely manner.

Reviewing and monitoring clinical data for safety assessments, verifying case report forms (CRFs), source documents and data entry into EDC systems like REDCap, Medidata, Rave, Medrio, eRAP, Advantage EDC, Oracle Inform etc. Resolving data queries, creating and updating data spreadsheets for subjects and maintaining clinical trials regulatory documents in eTMF ready for FDA audit.

Assisting in making presentations for weekly safety meetings with Key Opinion Leaders and HCPs for reviewing ongoing clinical data of studies and discussing safety measurements to minimize risk and improve outcomes.

Providing input into developing protocol, SOPs, case report forms and other training materials. Reviewing medical records for subject enrollment, responsible for drug accountability and communicating closely with hospital IDS and sponsors.

Providing training to CRCs and hospital nurses with clinical research protocols and SOPs for better execution of study protocol to minimize protocol deviations and improve study progression.

Drug Safety and Pharmacovigilance basic course certificate by BioPharma Institute, NJ June 2020

Comprehensive knowledge and training in following competencies:

Case processing via receiving AEs reports from unsolicited and solicited sources, verifying and assessing data according to its expectedness, seriousness, intensity and relatedness, coding of adverse reaction according to MedDRA, validation of ICSR, writing case narrative and reporting to regulatory agencies at defined time points.

Signal management- signal detection through active and passive surveillance, prioritization and assessment in terms of casualty, frequency, impact on patients, and preventability which help in creating risk management.

Risk evaluation and mitigation strategies- Medication guide, communication plan for healthcare providers, elements to assure safe use of medicinal products to reduce severity of certain risks.

Aggregate reporting- Authoring Development safety update report (DSUR), Periodic safety update report (PSUR), Periodic Adverse Drug Experience Report (PADER), Periodic Benefit Risk Evaluation Report (PBRER) which help in studying benefit/risk balance of medicinal product throughout product life cycle and submission to regulatory agencies at define time interval. Knowledge of IND/CTA and NDA applications, ICH E2A, E2B and E2C guidelines and product labeling.

Summit Clinical Research - Athens, Ga 11/2019 - 12/ 2019

Clinical Research Assistant Internship

Monitored progress of clinical trials ensuring data records and reports are accordance with ICH GCP guidelines.

Worked with the PI and under the supervision of the project manager for developing and implementing clinical operations for GI trials.

Maintained and organized clinical study binder including but not limited to 1572s, CVs, IRB-IEC documents such as approvals, renewals, DOA and other study agreements.

Reviewed protocol, regulatory issue, SOPs and provided required training to subject for taking investigational products safely. Reviewed clinical data from case report forms and source documents to ensure data compliance with ICH GCP guidelines.

Quickly resolved queries and random study site issues to maintain progress and prevent protocol deviation and regulatory penalties.

Performed IP storage inventory and made sure unused IP returned to sponsors. Reported SAEs in accordance with project specification and regulatory mandates.

Kidney Hypertension Clinic - Lawrenceville, Ga 02/2019 – 11/2019

Clinical Observership - Nephrology

Assisted Nephrologist with taking detailed medical history, physical exams and presented in standardized medical terms. Interpreted labs, ECGs, X-rays, Ultrasound and PET scan and delivered medical information in such common words so patients can comprehend.

Gained extensive clinical knowledge in treatment for chronic kidney disease, cardiorenal syndrome, metabolic and endocrine disorders associated with kidneys and dialysis. Provided differential diagnosis based on complaints, suggested initial diagnostic testing and completed patient's note in EDC.

Collaborated effectively and maintained professional relationships with other Health care providers (HCPs) such as Cardiologist, PCP, Hematologist, Rheumatologist and Vascular surgeon while referring patients for abnormal findings. Provided medical information and lab results with other HCPs upon request for better treatment options ensuring HIPAA compliance.

Assisted in daily clinic operation by performing administrative duties like insurance verification, managing drug sample inventory and answering multiple phone lines for responding to inquiries from patients.

Provided technical training to medical staff such as manually taking BP, Urine dipstick and Microscopy use. Developed SOP for taking accurate blood pressure.

With good organizational skills decreased patients waiting time to a minimum and increased patient scheduling by 100%.

Buford Medical clinic - Buford, GA 06/2017 - 12/2018

Clinical Observership - Family Medicine

Assisted Primary Care Physician and became familiar with the US healthcare system.

Performed vital signs, physical exams, took H&P, interpreted labs and ordered labs.

Developed strong communication skills with patients and other Healthcare professionals (HCPs).

Documented symptoms, medical histories and current medications into Electronic Data System like eCLinical.

Assisted administrative duties such as verifying insurance, scheduling patients, and maintaining clinic supply for smooth running of clinical operations.

Maintained professional relationships with Physicians, nurse practitioners and medical assistants.

Strengthened my Clinical Knowledge in patients with acute symptoms and making therapeutic plans.

Shukan Hospital - Ahmedabad, India 01/2015 - 05/2016

MD- Internal Medicine

Closely examined the patient’s medical history, medication allergies, symptoms and test results to properly diagnose illness and provided appropriate care. Assisted in clinic operations via working collaboratively with internal departments and successfully managed staff of 25 people including nurses and medical assistants.

Discussed various treatment options extensively with patient and improved patient’s quality of life. Educated patients regarding diet, hygiene and effective disease prevention methods.

Assisted in presentation for national conference and drafting treatment guidelines for DM type 2 treatments.

Effectively lead a team of medical interns and nurses with constant training and mentoring regarding patient care and support. Successfully completed a Hepatitis Vaccination project for rural areas..

Exhibited expert knowledge of policies, procedures, ethical standards and laws regarding medical care.

Attended a meeting with pharmaceutical representatives to learn about the latest treatment options available and provided feedback.

EDUCATION

●Clinical Research Fastrack - Atlanta, GA 2019

Certificate in Clinical Research

●Smolensk State Medical Academy - Smolensk, Russia 2014

Doctor of Medicine (MD)

Medical Degree includes clinical rotation in various departments including: Internal Medicine, Surgery, Infectious Disease, Cardiology, Hematology/Oncology, Pulmonology, Neurology, Psychiatry, Pediatric, OBGYN, Trauma, Gastroenterology, Dermatology.

CERTIFICATE AND TRAINING

●Drug Safety and Pharmacovigilance basic course certificate by BioPharma Institute, NJ.

●Overview of Drug Safety by CDERLearn training by FDA.

●Collaborative Institutional Training Initiative (CITI) certified in following

Biomedical Focus, ICH Good Clinical Practice, Clinical research coordinator and Health privacy.

●Certificate in GCP audit training by The Global Health Network.

●Medical Science Liaison Training: MEDICAL SCIENCE LIAISON SOCIETY(MSLS) webinars.

●Basic Life Support (CPR and AED) certified by American Heart Association.

CURRENT RESEARCH EXPERIENCE

A Phase I//II study of human placental hematopoietic stem cell derived natural killer cells (CYNK-001) in Multiple Myeloma patients following autologous stem cell transplant.

Winship 5001-20: Phase 1 of exposure targeted melphalan dosing for Multiple Myeloma patients undergoing autologous stem cell transplant.

A Randomized Phase III study comparing conventional dose treatment using a combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to high dose treatment with peripheral Stem cell transplant in the initial management of Myeloma in patient up to 65 years of age.

A Phase 1b/2 study to evaluate the safety, tolerability, pharmacokinetics. pharmacodynamics and clinical activity of EQ001 in subjects with acute graft versus host disease.

GRAVITAS-309: A Phase 2/3 study of Itacitinib and corticosteroids as initial treatment for Chronic Graft-Versus-Host Disease.

A multicenter, randomized, double-blind, Placebo-controlled Phase III trial of the FLT3 inhibitor Gilteritinib administered as maintenance therapy following allogeneic transplant for patients with FLT3/ITD AML.

GVH1201: Randomized controlled trial for Abatacept combined with a calcineurin inhibitor and Methotrexate for graft versus host disease prophylaxis.

CLI00112: A prospective, open label, Post marketing surveillance study following transfusion of INTERCEPT platelet components.

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