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Click here or scroll down to respond to this candidateCandidate's Name , CCRP, CCRCEMAIL AVAILABLEScottsdale, ArizonaQUALIFICATION SUMMARYOver 15 years of experience in clinical trials, working as a Clinical Trial Manager(Device)/CRA/CRC (Clinical Studies).Conducted clinical trials in various therapeutic areas including neurology, oncology, cardiology, and device studies (hematology and cardiology).Carried out clinical trial support activities for assigned trials, including coordination and documentation in CTMS and eTMF.Experience in planning, executing, monitoring, and reporting on clinical trials ensuring quality of clinical trials in phases I-IV in therapeutic area of oncology, neurology, cardiology and device studies.Implemented a risk-based approach to monitoring sites and provided specialized training for each trial.Created and conducted training programs for clinical sites teams including coordinators and investigators.Actively participate in and contribute to various trial team meetings at global, regional, and local levels, as well as at international, regional, and local Investigator Meetings.Possess knowledge of imaging procedures such as MRI/CT scan, EEG, EMG, and Evoked Potential.Thorough understanding of clinical protocols, scientific principles, statistical analysis, regulatory requirements (GCP/ICH guidelines), and quality/compliance standards for conducting clinical research.Proficient in implementing operational activities and project management tasks associated with clinical studies, ensuring successful, timely execution within budget constraints. Examples include central lab coordination, SAE tracking/reconciliation, and more.Well-versed in GCP, ICH, and FDA guidelines.Experienced in working with EDC systems such as Inform, Rave, CTMS, IMPACT, IMPACT My Site, IXRS, as well as SharePoint. Additionally, possess basic knowledge of SAS, Python, SQL, ORACLE AERS, Elara, Iview, and Pmed.Sound proficiency in Excel, MS Word, Outlook, and SharePoint.Skilled in clinical database search, preparation of case history/summary, report writing, discrepancy management, and verification of AEs and SAEs using source documents.Therapeutics and Indications (years):Gene TherapyCardiovascular Therapy: Heart Failure with low EF, Baroreflex Activation Therapy for Heart Diseases (1 y)Hematology/Oncology: Cancers of lung (4 yrs.), Breast (4yrs), Colon (2yrs), non-Hodgkins lymphoma (4 years), Multiple myeloma, CMS, Glioblastoma Multiforme (4 years)Infectious disease: COVID 19 (1y)Neuroscience: Seizures, Headaches, Dementias, Strokes, MS, Parkinsons Disease, Neuropathy pain (6 yrs.), Duchenne Muscular Dystrophy (6mo)EDUCATIONMGM Medical College, Jamshedpur, IndiaBachelor of Medicine and Surgery (MBBS) July/1986Co-operative College, Jamshedpur, IndiaIntermediate Science, July/1978Certificates:CCRC (ACRP) April 2004, CCRP (Center for Clinical Research Practice- Thomson Research)PROFESSIONAL EXPERIENCENovotech-CRO March 2023 to Jul 2023Charleston, NCSr. CRAInvolvement in operational oversight, timely and quality execution of the trials.Participate in SSV and SIV, presenting clinical protocol slides, create the report for site selection, monitors the active sites.Manage clinical sites, track study information, manage study team meetings, collaborating with cross-functional colleagues, coordinating study start-up activities, reviewing clinical data, conducting quality.Create Monitoring report, FU in Veeva Clinical, evaluate sites risk, monitoring frequency, issue resolution.Facilitate the achievement of study milestones and ensure effective communication and collaboration within the study team.Assist in developing essential documents, monitoring plans, annotated trip reports, monitoring tools and templates.Upload new documents to eTMF, review regulatory documents for audit readinessPPD Clinical Research (contract) Aug 2022 to Nov 2022Wilmington, NCResponsible for performing and coordinating all aspects of the clinical monitoring and site management process, including conducting remote or on-site visits to evaluate protocol and regulatory compliance and overseeing necessary documentation.Proficient in managing procedures and guidelines from various sponsors and monitoring environments (such as FSO, FSP, Government) to ensure adherence to trial requirements.Serves as a specialist in site processes, diligently ensuring that the trial is conducted in full compliance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, prioritizing subjects' rights, well-being, and data reliability. Maintains audit readiness throughout the trial.Develops and fosters collaborative relationships with investigational sites, promoting effective communication and cooperation to facilitate smooth trial operations.TIMI Clinical Research Aug 2020 to 11 Mar 2022Brigham Woman HospitalBoston, MassachusettsClinical Research Monitor (remote)Monitor a vaccine trial A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease and a Covid Trials COVID-PACT is a multicenter, randomized, open-label, trial of full-dose anticoagulation vs. standard-dose prophylactic anticoagulation and antiplatelet therapy vs. no antiplatelet therapy on the risk of venous or arterial thrombotic events in ICU patients with COVID-19.I remotely monitor 20 sites for the vaccine trials and about 12 sites for the Covid protocol.Trained site staff on protocol requirements, proper source documentation, and case report form completion.Overseeing and documenting IP dispensing inventory, and reconciliation.Verification of Informed Consent documents and procedures for their integrity, completeness, privacy, and documentation.Verify IP has been dispensed and administered according to protocol.Conducting regular site visits, coordinating project meetings, and writing visit reports.Implementing action plans for sites not meeting expectations.Liaising with regulatory authorities.Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.Clinical Research Consultant (CRA) Mar 2018 to Dec 2019MD First Clinical ResearchChandler, AZConducted trials in resistant epilepsy, migraine headaches, postural hypotension in phases II and III and cardiac device study.Assists manager in reviewing ICFs, monitoring plans, monitoring reports, updating supplies, investigational products.Screens, consents, enrolls, and follows study subjects ensuring protocol compliance and close monitoring while subjects are on study utilizing Research Nurses oversight for help with clinical decision making.Responsible for all data and source documentation, adverse experience reporting, and will assist Regulatory Specialist in the maintenance of complete regulatory files.Ensures that randomization procedures and blinding procedures, as applicable, are followed as per protocol guidelines.Schedules and performs patient procedures, assessments, evaluations and testing as required by the protocol, including but not limited to blood sample collection, processing and shipping, ECG, vital signs, etc., as applicable. Accurately planned monitoring activities according to workload at each site, submitted reports, completed monitoring visit schedules, created study and site contacts, templates.Participated in data cleaning process by resolving the inconsistent, inaccurate, or missing data in source documents and CRFs.Updated and FU the Open Action Items, deviations, Imaging Scans, protocol queries.Translational Research in Oncology (TRIOncology) Aug 2016 to Feb 2017Sr. CRAParticipated in a Phase 3 clinical study focused on locally advanced and/or metastatic triple negative breast cancer patients who had previously undergone chemotherapy for metastatic disease.Monitored activities at assigned clinical study sites to ensure compliance with ICH Good Clinical Practice (GCP) guidelines, local regulatory requirements, TRIO Standard Operating Procedures (SOPs), Standard Guidelines (SGs), Instruction Manuals (IMs), study protocols, and study specific SGs/IMs for multiple projects.Conducted Pre-Study Site Visits (or calls), Study Initiation Visits, Routine Monitoring Visits, and Site Close-out at assigned clinical study sites in accordance with TRIO SOPs/SGs/IMs and study specific SGs/IMs.Performed source document verification, verified Case Report Forms (CRFs), and resolved queries in a timely manner to ensure the availability of clean data for study analysis.Ensured the reporting of Serious Adverse Events (SAEs) according to project specifications.Input and maintained study information in tracking systems, providing regular and accurate updates on site status and common trends to Monitoring Resources and Project Management Departments.Oversaw the management of study drugs at clinical study sites, including their availability, receipt, handling, storage, dispensation, tracking, accountability, and destruction/return.Conducted reconciliation of Investigator Study Files, requesting any new or updated essential site-related documents and reviewing them for content, consistency with other documents, and compliance with local regulatory requirements, ICH-GCP guidelines, and SOPs. Demonstrated sound knowledge of GCPs and ICH guidelines.Reviewed protocols and budgets submitted through portals, discussed eligibility and scope with the cross-functional team, prepared budgets, negotiated contracts, and closely monitored milestones and deliverables.Responded promptly to requests from clinical study sites.Assisted during on-site audits when necessary and participated in the preparation of site audit report replies. Helped implement corrective and preventive actions as needed.Adhered to corporate internal policies and requirements, including timely submission of training documentation, visit planning, timesheets, and expense reports.Novella Medical Oct 2014 to Feb 2015Sr. Clinical Research Associate/consultantReviewed feasibility questionnaires to identify sites, develop Clinical Monitoring Plan, Study Forms/Templates for ICF, Site Visits (SIV, IMV, COV), IP accountability Logs.Clinical Trials Involved:oAn International, Randomized, Double-Blind, Controlled Study of XXX/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFR VIII-positive Glioblastoma.oA Phase I/II Study of IMMU-XXX (Antibody Drug Conjugate) in Patients with Epithelial Cancers (Renal Cell Carcinoma, Esophageal Cancer, Ovarian Epithelial Cancer, Thyroid Cancer, Follicular Ovarian Cancer Glioma Neuroepithelioma)oPhase Ib Study of SC Milatuzumab in SLE.oPhase I Study of Milatuzumab for Graft Versus Host Disease GVHD (Acute or Chronic); Acute Myeloid or Lymphoblastic Leukemia (AML or ALL); Myelodysplastic Syndrome; Chronic Myelogenous Leukemia (CML); Multiple Myeloma (MM); Non-Hodgkins Lymphoma (NHL-both Follicular & Diffuse Large Cell); Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia (CLL or SLL)Operational input into study documents such as synopsis, protocol, ICF, CRF Completion Guidelines,Reviewed Medical Safety reports, status of queries and Identification of risks and created risk mitigation plan.Monitored the AEs/SAEs for source verification and reconciliations, IRB reporting requirements.Followed up with important safety related issues, regulatory documents, supplies, drug inventories.Presentation of the protocol at the sites, protocol related training of site staff.Assisted with budget and contract reviews and tracked budgets for ongoing clinical studies.Siemens Healthcare Diagnostics, Tarrytown, NY Mar 2014 - Sept 2014Clinical Study ManagerTherapeutic Area: Hematology Analyzer (Device Study)Involved with a hematological device trial for the blood sample collections in cancer patients.Developed validation and verification protocols for this device.Selected sites, investigators, negotiated budget and contract for the clinical study.Provided the clinical input for the important documents, reviewed the approved regulatory documents, ensured all documents collected, training completed before starting the siteManaged budgets, forecasts, and timelines.Therakos (J&J Subsidiary), Bridgewater, NJ Jul 2012 to Sept 2013Clinical Study Manager (Investigator Initiated Studies)Managed all aspects of Investigator Initiated phase Photopheresis Device Studies for cutaneous lymphoma.Reviewed study proposal, budget, and feasibility for the studies.Negotiated and tracked study budgets,Preparing the Purchase Orders and managing invoices siteUsed Impact CTMS.I3 Research/United Healthcare, New York Oct 2009 to Jun 2012Clinical Study Manager (Investigator Initiated Study)Therapeutic areas: HIV related Lymphoma, HIVResponsible for oversight and management of Investigator Initiated TrialsReviewed the application, supplied protocol for suitability.Organized the committee meeting, prepared agenda to discuss the details of the protocol, budget, requirements, deliverables, pending items or issues.Experience with IMPACT and CTMS applicationsPrepared Study Budget and Investigator Agreement in collaboration with the team, tracked the agreed milestones and made the payment for completed task.Responsible for updating the action items, ongoing communication with clients, shareholders.Actively communicated and established productive relationships with the cross-functioning departments.Translational Cancer Research, Scottsdale, Arizona Oct 2008 to Sept 2009Clinical Study Coordinator - Phases I and II TrialManage day-to-day operational aspects of a clinical trial, providing oversight and guidance to the clinical team.Extracted data and medical information from medical records and laboratory reports and entered respective data into CRF database.Identified, recorded, reported, and discussed AEs and SAEsReviewed medical charts, authored reports, and reviewed the compliance of study conduct according to appropriate guidelines.Track recruitment activities at the sites to ensure timely enrollment of studies; escalate emerging issues requiring input from management.Reviewed radiology and histological reports to assess protocol inclusion & exclusion criteria.TRIAL EXPERIENCES:A Phase I, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, PI, PD, and Antitumor activity of DCSZ11 as a Monotherapy in Patients with Advanced or Metastatic Sold Tumors.A Phase 1b, Open-Label, Controlled Trial Evaluating the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subject with Cardiomyopathy Secondary to Duchenne Muscular Dystrophy.Barostim NEO Baroreflex ActivationTherapy for Heart Failure (BeAT-HF)A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Padsevolin As an Adjunctive Treat of Focal-Onset Seizures in Adults Subject with Drug- Resistant Epilepsy.oA Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine PreventionoA clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy.An International, Randomized, Double-Blind, Controlled Study of XXX/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFR VIII-positive Glioblastoma.A Phase I/II Study of IMMU-XXX (Antibody Drug Conjugate) in Patients with Epithelial Cancers (Renal Cell Carcinoma Esophageal Cancer Glioblastoma Ovarian Epithelial Cancer, Thyroid Cancer, Follicular Ovarian Cancer Glioma Neuroepithelioma)Phase Ib Study of SC Milatuzumab in SLEPhase I Study of Milatuzumab for Graft Versus Host Disease GVHD (Acute or Chronic); Acute Myeloid or Lymphoblastic Leukemia (AML or ALL); Myelodysplastic Syndrome; Chronic Myelogenous Leukemia (CML); Multiple Myeloma (MM); Non-Hodgkins Lymphoma (NHL-both Follicular & Diffuse Large Cell); Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia (CLL or SLL)Phase III double blind controlled trial for Glioblastoma of brain.A Phase I Trial of xxx (xxx) Plus xxx in Patients with Advanced Metastatic Pancreatic Cancer.Phase I clinical and pharmacokinetic study of xxx and xxxx every 3weeks in patients with advanced refractory solid tumors 06-01.A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet Plus Acetazolamide vs Diet Plus Placebo in Subjects with Idiopathic Intracranial Hypertension with Mild Visual LossA First in Man Phase I Study of xxxx, a microtubule inhibitor anti-cancer drug with tumor vascular endothelial disrupting activity: Intravenous administration daily for three days in patients with advanced solid tumors and lymphomas.Phase I Study of (xxx), an xxx and xxxx 1 (Cdc2) inhibitor, In Patients with Leukemia.A Phase 1, Multi-center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of xxx Administration IV Weekly for Three Weeks and Repeated Every Four Weeks to Patients with Advanced Solid Tumors or Lymphoma.XXX (XXX) vs. YYY for the Treatment of Women with Chemotherapy-Therapy Nave Advanced Non-Small Cell Lung Cancer (NSCLC) who is Performance Status 2.A Phase 2 Study of xxx in Patients with Follicular Lymphoma.A Phase 3 Clinical Study to Investigate the Prevention of Relapse of Lymphoma Using Daily xxx.A Randomized Phase 2 Study of xxx plus xxx with or without xxx in Patients with Recurrent Colorectal Cancer.A Randomized Phase 3b study of the Three Treatment Regimens in Subject with Previously Untreated Multiple Myeloma.A Phase III, Randomized, Double-Blinded, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of ZD6474 in Combination with Pemetrexed Vs. Pemetrexed alone in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer after Failure of 1st Line Anti-Cancer Therapy.A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-Range Exploration Study of Fentanyl Patch in Relieving Pain in Patients with Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.Bone Marker Directed Dosing of Zometa for the Prevention of Skeletal Complications in Patients with Advanced Multiple Myeloma.Phase 3 Randomized Study of XXX (XXX) in Combination with XXX (XXX/YYY) versus ZZZ as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer.A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fentanyl Tablet for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients Followed by an up to 12-month No-Randomized, Open-Label Extension to Assess Long-Term Safety.A double blind, randomized, placebo controlled, parallel group study of the analgesic efficacy, safety, and tolerability of XXX compared with placebo in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy (XXX) followed by an open-label extension study (YYY).A Randomized, Double-Blind, Parallel-group, Multicenter, Phase III Study Comparing the Efficacy and Tolerability of XXX (XXX) YYmg with ZZZ YY mg in Postmenopausal Women with Estrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy.A Phase II, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Multicenter, Safety and Efficacy Evaluation of Three Doses of XXX in Patients with Mild to Moderate Dementia of the Alzheimers Type xxx - Prevention Regimen for Effectively Avoiding Second Strokes: A Double-Blind, Active, and Placebo Controlled Study of XXX vs. YYY plus Aspirin, with and without Micardis.A Phase II, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of XXX Monotherapy in Patients with Moderate to Severe Dementia of the Alzheimers Type.A Study to Evaluate the Percentage Agreement and Utility of Urinary Neural Thread Protein Measurement in Subjects with or Without Probable or Possible Alzheimers Disease.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of Titration and Treatment with XXX in Subject with Mild Cognitive Impairment (MCI).Oral Direct Factor Xa Inhibitor XXX in the Prevention of VTE in Patients Undergoing Total Knee Replacement. A Randomized, Controlled, Double-Blind, Double-Dummy Phase IIB Dose-Ranging Trial.Keywo0rds: High Level Site Monitoring Role Monitoring Strategy Protocol Deviations Authorship and Authoring Trial Level Documents Monitoring CTM (Clinical Trial Material) and CRAs (Clinical Research Associates) Support for 3-4 Phase 3 Trials in Therapeutics (Oncology, Cardio Metabolic, CNS - Central Nervous System, Inflammation Stage) Strong Communication Skills Leadership in Monitoring Experience with CRO (Contract Research Organization) Resources, Matrix Environment CRA Oversight Globally Database Lock Experience Meeting Investigators Inspection Readiness Responsibilities: Execution of Monitoring Plans Quality of Monitoring by CRAs Conduct On-Site Visits and Co-Monitoring Implement Monitoring Plan in Trial Team Risk-Based Site Monitoring Training Local Trial Teams (CT Managers, CRAs) Site Monitoring Inspection Readiness Consultation on Site Management and Monitoring Participation in Trial Team Meetings Trial Conduct: Oversight of Site Management and Monitoring by CRO Partners Adherence to ICH-GCP, Regulatory Requirements, SOPs, Trial Protocol Issue Management and Oversight Risk Identification and Evaluation Maintain Risk-Based Site Monitoring Conduct Site and Monitoring Oversight Preparation and Implementation of Trial Level Documents Communication and Training Related to Site Monitoring Trial Closeout: Coordinate Cleaning and Delivery of Clinical Trial Data Education: Bachelors Degree in Health Sciences, Health Care 5+ Years of On-Site Monitoring Experience or 8 Years in Regulated Pharmaceutical/Healthcare Industry Skills: Oncology, Metabolic, Dermatology, CNS Experience |
