Clinical Research Associate
Resume:
Naveen Clement B.Pharm, MS, CCRA, CCRP, (PMP), (CAPM)
***************@*****.***
CANDIDATE PROFILE
Principal Clinical Research Associate with over 17 years of experience in Clinical Research and Industry in different roles including Global Clinical Trials/Team Manager, Principal Clinical Research Associate, Clinical Lead, and Research Associate roles. As a CRA, worked as both blinded and unblinded monitor on 25 Clinical trials in Cardiovascular, Infectious/Parasitic Disease, Device, Digestive, Genitourinary, Nervous System, and Hematology/Oncology Therapeutic Areas. Experience in Clinical trials phases I, II, III, IV, observational, multicenter, randomized, open-label, parallel group, dose-ranging, placebo-controlled and double-blind studies in the adult population. Conducted all types of monitoring visits: PSV, SIV, IMV, and COV, on-site and remote with 100% or reduced SDV and SDR. Experienced in AIM methodology and Risk-Based Monitoring principles. Used different clinical and/or client-specific systems for trial management, such as eDC, eDiaries, eConsent, IVRS/IWRS, and participated as CRA in several Sponsor audits, FDA inspections, and third-party QOVs (Quality Oversight Visits).
Demonstrate the ability to prioritize and meet deadlines. Handled 50+ interim analyses, data cuts, PI sign-off & Audit readiness timelines. Responsible for project management deadlines, proficient in problem solving, and demonstrate the ability to meet deadlines efficiently. Good working knowledge and ability to represent as a medical therapeutic expert. Expert and certified in GCP, ICH guidelines & Clinical Research Plan development that includes Monitoring Plan development, Cell handling plan, Protocol Deviation plan, Risk Management Plan & IP destruction, and handling Plan. Exhibited understanding with US Federal Food and Drug Administration, ICH/GCP and European Regulatory Authority requirements as applicable to a study (or the countries a study is conducted in). AS CPM understanding of the development process from Phase 1 through Phase 4 for drug and/or device trials. As CPM Possesses working knowledge of research objectives, protocol design, and data collection standards. As CPM Experience with clinical operations systems including EDC, CTMS, and eTMF. As CPM Experience in project management practices EDUCATION
• M.S., Interdisciplinary Program in Natural Science concentration in Oncology, 2007 Roswell Park Cancer Institute, State University of New York at Buffalo, Buffalo, NY, USA
• B.Pharm, Pharmaceutical Sciences, 2000
Sri Ramachandra Medical College & Research Institute, Chennai, Tamil Nadu, India PROFESSIONAL AFFILIATIONS
• Member of the Society Clinical Research Associate (SoCRA) 2012
• Member of the Association of Clinical Research Professionals (ACRP) 2022 CERTIFICATIONS
• CCRA - Certified Clinical Research Associate – Since April 2022.
• CCRP - Certified Clinical Research Professional - Since March 2023
• Registered Pharmacist with good standing in Tamil Nadu, India 2000
• ACCRP – Certified Clinical Research Professional – July 2023
• (PMP) – Project Management Professional – (Aug 2023 Exam)
• (RAPS) – Regulatory Certification Program (Aug 2023 Exam)
• (MWC) – Medical Writer Certified (Aug 2023)
THERAPEUTIC AND INDUSTRY SUMMARY
Therapeutic Units & Indications (yrs)
● Cardiovascular/Metabolic/Critical Care: Acute Coronary Syndrome (1y), Stroke (0<1y), Bypass Graft (0<1y), Angina pectoris (0<1y), Myocardial infarction (0<1y), Stroke (0<1y)
● Devices: Pulmonary artery catheters (0<1y), Stents (0<1y), Cardiovascular device(0<1y)
● General Medicine: Chronic Kidney Disease (1y), Renal Failure (1y), Osteoarthritis (0<1y)
● Hematology/Oncology: Solid Tumors (3y) Head and Neck cancer (1y), Leukemia CLL (5y), Breast Cancer (3y), Liver cancer (1y), Cervical Cancer (0<1y), Prostate Cancer (0<1y), Pancreatic Cancer (0<1y), Colon Cancer (0<1y)
● Esophageal Cancer (1y), Kidney Cancer (1y), Ovarian Cancer (1y), Lung cancer NSCLC (0<1y), Lung Cancer - SCLC
(0<1y)
● Infectious & Respiratory Diseases: HIV-1 (1y), Respiratory Tract Infection (1 y), Tuberculosis (1 y), COPD (1y)
● Neuroscience: Alzheimer ’s Disease (<1 yr), Anxiety (0<1y), Panic Disorder (0<1y) Study Phases
● PH I, IIa, II, III, IV, multicenter, global, double-blind, observational, randomized, open label, parallel-group, dose-ranging, Cohort dose escalation, placebo controlled studies Patient Populations
● Adult
Global/Regional Scope
● North America (USA) APAC (India)
THERAPEUTIC EXPERIENCE AND EXPERTISE
• Cardiology/Vascular diseases: Acute Coronary Syndrome (ACS), Angina pectoris, Bypass Graft, Myocardial infarction, Stroke
• Devices: Cardiovascular devices, Pulmonary artery catheters, Stents
• Digestive: Ulcerative Colitis
• Genitourinary: Chronic Kidney Disease, Renal Failure
• Hematology/Oncology: Breast cancer (Ph I), Colon cancer, Esophageal cancer, Head & Neck cancer (Ph I), Kidney Cancer, Leukemia – CLL (Ph I), Liver cancer, Lung cancer (NSCLC- SCLC), Pancreatic cancer, Prostate cancer, Cervical cancer, Ovarian cancer (Ph I), Sarcoma, Solid tumors (Ph I) & Immuno-Oncology.
• Infectious/Parasitic Diseases: HIV/AIDS (Ph I), Respiratory tract infections, Tuberculosis
• Mental/Psychiatry Disorders: Anxiety, Panic Disorder
• Musculoskeletal: Osteoarthritis
• Respiratory: COPD
ADDITIONAL RELEVANT EXPERIENCE
• Audit Experience: Lab Audits & Investigator site audits
• Computer Experience: Medidata Rave, INFORM, iMedidata, IWRS, CTMS, CASCADE, eDairies, eCOA, PROFESSIONAL EXPERIENCE
Thermo Fisher, WILMINGTON, NC, USA
• Assistant Clinical Trial Manager CPM & Principal CRA, APR 2021 – June 2023 As CTM accountable for the operational management of the local component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards. Leads local trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted and reported in line with regulatory requirements. Requires orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial. Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites. Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have an impact on project deliverables (e.g. timelines, costs, integrity of trial data)More than one assignment in parallel requires balancing conflicting priorities. Is involved in the design and implementation of new innovative methods as a working group member.
I Lead the local trial team as an OPU Clinical Trial Manager (CTM), Trial Preparation, Conduct and Closeout:I collaborated with Site Monitoring Lead and CRAs, ensure Trial contact for CRAs, investigators and site staff are intact. Showed Solid project management, networking/stakeholder management and team leadership capability. Understanding of the scientific and/or technical components of the clinical development process, and associated regulatory requirements. I showed Technical Expertise: Demonstrated knowledge across all aspects of clinical trial operations and execution. Showed Knowledge in a relevant Therapeutic Area is an asset to CRO. Performed Dimensions of trial complexity for this project management role include protocol, trial subjects, sites, countries, suppliers. Ability to work across several studies and in different Therapeutic Areas.
Partnered with sponsor to develop clinical study plan for each project including timelines and budgets for the clinical program. Prepared directly or facilitated preparation of study documentation including protocols, case report forms, informed consent, enrolment feasibility evaluations and all relevant internal plans required for study conduct. Lead the day-to-day oversight of the CRA personnel plus the project budget, deliverables and timeline/milestones. Site activities (either directly or managing others): Identify and assess study sites, conduct investigator meetings and site training, prepare and execute research agreements and negotiate study budgets.Study monitoring (either directly or managing others): Formulate clinical monitoring plan, perform study initiation visits, manage clinical study monitoring resources, oversee standard interim monitoring visits and closeout activities. Performed study closeout procedures, directly or through other resources, including accurate completion of critical documents, disposition of study product and preparation of study sites for regulatory authority audits. Developed and maintained tracking systems as needed for study management, e.g. screening, enrolment, study completion, (serious) adverse events, budgets and forecasts, milestones. PPD, WILMINGTON, NC, USA APR 2020 – Apr 2021
PRINCIPAL CRA
As Principal CRA currently working on 1 phase IV, multicenter, observational Liver cancer study, as PCRA on 1 phase II, randomized, open-label (formerly double-blind) Kidney Cancer and on 1 phase Ib advance Solid Tumor Dose Escalation Cohort study in adult subjects. As a UCRA working for 1 phase Ib randomized, blinded, proof-of-concept study in HIV-1 infected adult subjects. As a Floater CRA & Primary CRA working for a Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes in Patients with Solid Tumors. Performed remote qualification visits for Phase III An Adaptive Randomized, Open-Label, Multicenter Study to Compare the Efficacy & Safety of Chimeric Autologous T cells vs Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphomas. Performed remote qualification visits for Phase II for A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Chimeric Autologous T cells in Adults with Rare B-cell Malignancies. As unblindedCRA Verified dose assignment, IP accountability, dose preparation, administration time, IP inventory at the site, and confirmed if the study blind was intact. Coordinated all aspects of the clinical monitoring and site management process. Work on AIM and KRI-based studies. Perform in-house startup, initiation, interim and close-out, on-site and remote activities. Perform remote eCRF and Online Reg.Binder and other study systems are reviewed on an ongoing basis. Involved in the site payment process. Maintain regular site staff contacts, training, and query resolution support. Participate in the local interim analysis. Ensure data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities. Assess investigational products through physical inventory and records review. Document observations in reports and letters. Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. Provide updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM). Facilitate effective communication between investigative sites, the client company, and the PPD project team. Ensure study systems are updated. Perform QC check o reports generated from the CTMS system. PPD
SENIOR CRA II, NOV 2016 - MAR 2020
As Senior CRA II worked on 2 phase I-II, III, Dose Escalation studies in Hematology/Oncology (Solid Tumor, Breast Cancer, Colon Cancer, Esophageal Cancer, Prostate Cancer, Head & Neck Cancer, Lung Cancer-NSCLC) in adults and on 1 phase I study in Ulcerative Colitis for the adult population. Supported the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables including database hard-lock & final CSR. Independently managed the study start-up activities for multi-center, US studies. Performed on-site visits
(feasibility,
SIV, IMV, Close-Out) as needed to assess the site’s overall performance. Provided monitoring oversight by reviewing monitoring schedules, metrics, and reports. Responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes, and SOPs. Participated in vendor management activities. Performed in-house routine data listings reviews. Collected, reviewed, and monitored required regulatory documentation for study start-up, study maintenance, and study close-out.
PPD
SENIOR CRA I, FEB 2013 - OCT 2016
As a Clinical Research Associate worked on 3 phases I-III, randomized, double-blind, and open-label Clinical trials in Hematology-Oncology (Leukemia-CLL) in adult outpatient and in-patient populations. Performed initiation, interim monitoring, and close-out visits remote and on-site visits. Performed a combination of 100% remote and on-site monitoring for 100% SDV for the studies. Participated in clean data transfer. Used client CTMS and clinical systems. Sites achieved top enrolment rates in a limited enrolment period. Responsible for site management according to the ICH/GCP, local regulations, and Company and Sponsor SOPs. Performed pre-study, initiation, interim monitoring & close-out visit. Both subject-level accountability and Master level accountability were performed throughout the study. The final reconciliation of IP was performed at the end of the study and necessary documents were collected at COV. Performed document management and essential document collection and submission to eTMF. Performed cross-verification between ISF binder vs TMF for regulatory compliance and audit preparedness. Oversee site staff contact collection, query resolution support, data query issuance, and site performance tracking for quality adherence at the site. Used systems such as CTMS, CASCADE, ORACLE Inform, IMPACT, Medidata Rave, Bracket RTSM, & Bracket IWRS for data review
& IP accountability. Provided medical input into key program deliverables, throughout the clinical development cycle. Responsible for optimal planning and execution of clinical studies. FLADGER ASSOCIATES, WILMINGTON, DE, USA
• SENIOR CRA, MAY 2012 – FEB 2013
As Senior CRA oversaw the conduct of clinical study for 1 phase I oncology study for adult subjects with lung Cancer SCLC/NSCLC. Acted as liaison to clinical investigators, ensuring the quality and integrity of data in Medical Affairs. The managed annual budget for the clinical research facility. Prepared and conducted study initiation, closeout, and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols, and project plans by FDA regulations. Prepared internal files and Project Manager File for clinical quality and FDA audits/ inspections. Participated in preparation for the conduct of FDA and internal QA inspections and audits. Served as a resource to team members with protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issues. VECTOR CLINICAL, CHENNAI, INDIA – LOTUS CRO & VARIOUS SPONSOR
• GLOBAL CLINICAL TRIALS TEAM MANAGER & CPM QA Manager, MAR 2011 – MAY 2012 Prepared all associated documentation including audit plans and audit reports following established procedures. Worked on 5 phases II-IV, start-up Clinical trials in Genitourinary (Chronic Kidney Disease, Renal Failure), Hematology/Oncology
(Cervical cancer, Melanoma, Ovarian cancer, Sarcoma), Infectious/Parasitic Diseases (Respiratory tract infection, Tuberculosis) and Respiratory (COPD) in the adult population. Analyzed feasibility questionnaires and start-up activities. Performed start-up activities for a sponsor. Ensured that clinical trials follow Protocol, SOPs, ICH, and GCP compliance guidelines. Responsible for co-monitoring with and oversight of CRO CRAs. Reviewed resolution plans and verified plan resolutions leveraging areas for continuous process improvement. Participated in the drug safety and monitoring (DSMB) meeting in the TRD sub-team. Driven drug supply process in TRD and ensured key project milestones were met. Responsible for Developing Contracts, procurement of research services, and managed negotiation. Directed implementation of Research Protocols. Recruited Study Coordinators. Developed and negotiated Financial Agreements managed the Budgeting and logistics of the division. Evaluated and analyzed clinical data, monitored clinical study records while documenting findings and resolving discrepancies. Performed strong CRA oversight and trip report review for query
resolution. Worked closely with site EC for the multi-cultural patient recruitment advertisement. Serve as a resource to team members with protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issues.
FLADGER ASSOCIATES, WILMINGTON, DE, USA – CLIENT - JOHNSON & JOHNSON
• CONTRACT CLINICAL RESEARCH ASSOCIATE, AUG 2010 – FEB 2011 Monitored the safety of OTC, consumer healthcare products, medicines as used in everyday practice to identify previously unrecognized adverse effects, adverse events, or changes in the patterns of adverse effects. Reviewed and approve site contracts, informed consent forms, study budgets, work orders, and invoices before final approval. Responsible for compliance and completeness of Project Master File (PMF) of recalled products. Maintained Trial Master File (TMF) ensuring study documents are filed by client SOPs. Performed vendor management by tracking invoices from service providers and proactively identifying issues and developing problem-solving strategies for assuring study timeliness are met.
MAKRO TECHNOLOGIES, NJ, USA – CLIENT - MEDTRONICS
• CONTRACT CLINICAL RESEARCH SPECIALIST, DEC 2009 - JUL 2010 Responsible for assisting in the conduct of clinical research projects by good scientific principles and government regulations for 1 Cardiovascular Device study involving Cardiovascular Stents, Bypass Graft, Pulmonary artery catheters. Assisted in preparation and review of study materials, update of study logs, preparation for study payments, quarterly payments, creation of study letters and reminders. Reviewed monitor visit reports, entry of trial management information into the study database, reviewed study files and site and study documents to ensure compliance with departmental SOPs/DOPs, the protocol, and regulations. Archived study material. Monitored resource requirements on an ongoing basis in partnership with CoEs, Vendors, and FSPs to maximize efficiency and productivity. MAKRO TECHNOLOGIES, NJ, USA
• CLINICAL TRAINER, MAY 2009 - NOV 2009
Trained CRAs in conducting Sponsor based inspections in preparation of FDA Audit. Trained in conducting effective quality assurance audit, and planning for its successful implementation. Taught student types of audits that are conducted at investigative sites, and the value they provide. Taught CRAs to prepare and perform the close-out visit, follow-up audits and to get the best out of for-cause audits. FLADGER ASSOCIATES, WILMINGTON, DE, USA – CLIENT ASTRAZENECA
• CONTRACT STUDY DELIVERY OPERATIONS SPECIALIST, FEB 2008 - APR 2009 Responsible for assisting in the conduct of clinical research projects in 1 phase III Cardiovascular multicenter Global double-blinded randomized Cardiovascular study in the adult population. The study was an event-driven endpoint study to evaluate the Cardiovascular Events such as Acute Coronary Syndrome, Myocardial Infarction, Angina pectoris, Arrhythmia, Stroke, Heart attack when treated with platelet aggregation inhibitors in study populations globally. Conducted in-house as well as onsite activities by good scientific principles and government regulations. Prepared sites for SIV, conducted Co-monitoring and Pre-study evaluation visits. Completed assigned tasks related to clinical study payments processing, deviation tracking & IRB approval tracking. Tracked study progress and ensure data integrity. Verified that data entered onto the CRFs (EDC) is consistent with the patient clinical chart. MAKRO TECHNOLOGIES, NJ, USA – CLIENT - MERCK
• CONTRACT RESEARCH ASSOCIATE, APR 2007 - SEP 2007 Assisted in the conduct of research projects by good scientific principles and government regulations. Examined protein-protein interaction at the molecular level. Purification and restriction enzymes digest DNA for transfection of cell lines. Oversaw Phase research reports for data management. Conferred with end-users to define or implement research system requirements such as data release formats, delivery schedules, and testing protocols. Processed clinical data including receipt, entry, verification, or filing of nformation. Trained staff on technical procedures on software programs used for genomic analysis. Prepared data analysis listings and activity, performance, or progress reports. Contributed to the
compilation, organization of research data.
ROSWELL PARK CANCER INSTITUTE & SUNY BUFFALO, NY, USA
• RESEARCH AFFILIATE, DEC 2002 - SEP 2004
Assisted in the conduct of research projects by good scientific principles and government regulations. Examined protein-protein interaction at the molecular level. Purification and restriction enzymes digest DNA for transfection of cell lines. Worked on study projects in wet labs to look at Pancreatic cancer cells and colon cancer cells and establish tumor gene suppression and enhancement. Oversaw Preclinical Phase research reports for data management. Conferred with end-users to define or implement research system requirements such as data release formats, delivery schedules, and testing protocols. Worked on an observational study in collaboration with the University at Buffalo for Mental Disorders
(Anxiety,
Panic Disorder), Nervous System (Alzheimer's disease), and Musculoskeletal (Osteoarthritis) in the elderly population. Provided support and information to functional areas such as marketing, clinical monitoring, and medical affairs. Contributed to the compilation, organization, and production of protocols, and clinical study. LANGUAGES
Native Tongue: English, Tamil
ADDITIONAL TRAINING UNDERGONE
• ACT ACADEMY Courses, Cancer Immuno-Oncology, CAR T-CELL THERAPY, BEYOND CAR T-CELL THERAPIES, GLOBAL MANUFACTURING OF CAR T CELL THERAPY, PRODUCTION OF CHIMERIC ANTIGEN RECEPTOR T CELLS, TRIAL CONSIDERATIONS FOR ADOPTIVE CELL THERAPY, ACT OPERATIONAL PLATFORM OVERVIEW, IRRECIST AND IRECIST MAY 2017 & ACT CLINICAL LOGISTICS COORDINATOR.
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