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Click here or scroll down to respond to this candidateCURRICULUM VITAECandidate's Name
OVERVIEWJohn is a critical thinking, independently motivated professional in the areas of Pharmaceutical and Medical Device Clinical Trial Monitoring, and has managed over 78 compound and 10 device trials in development Phases I-III as a Senior and Lead Clinical Research Associate. John is also expert in EDC software systems and has taught EDC to Study Coordinators and Investigators at an Investigator Meetings. He has experience in Auditing GCP (Good Clinical Practices), GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) He has excellent communication and interpersonal skills, with a Project Managers sense of detail and problem solving capabilities. He holds a BA from The University of Minnesota.THERAPEUTIC EXPERIENCEMedical Device, Oncology, Internal MedicineMedical Device A Phase IV, Randomized Open Label Trial Measuring the Effect of Pulsed Electromagnetic Fields on Post-Operative Pain from ACL Knee Reconstruction with Patient Reported Outcomes. The ACL study required thorough knowledge of orthopedic assessments (Looking at radiology reports, physicians progress notes etc., that all were verifiable and correctly entered into the CRF) in subjects pre and post ACL repair (detailed radio graphic assessment, WOMAC and VAS std scoring, range of motion, etc.). The study was designed to specifically measure the effects of PEF on post-operative pain reduction, patient reported outcomes including: decreased inflammation, decrease in edema, effect on weight bearing, and effects on sleep habits A Phase IV Clinical Trial on the Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: Pilot, Open Label Study. A Phase IV Clinical Trial on the Effects of Pulsing Electromagnetic Fields on Osteoarthritis Knee pain of at least 3 months duration: A Randomized, Placebo-Controlled. Double Blind Study. 28 Day active treatment with long term follow up. A Randomized Double-Blind, Placebo Controlled Trial to Establish the Effect of Pulsing Electromagnetic Fields on Bone Mineral Density in subjects with Osteoperosis of the Spine. A Randomized, Controlled Pilot Study. A Randomized Open Label, Comparator Trial Measuring the Effect of Pulsing Electromagnetic Fields on Related Spine Pain in Post-menopausal Women in Bisphosphonate therapy alone or Bisphosphonate Therapy plus PEF. A Phase IV, Randomized Clinical Trial on The Effect of Pulsed Electromagnetic Fields on Shoulder Pain of at least 3 months Duration. A Randomized, Placebo Controlled, Double Blind Study. A Phase III Multicenter, Randomized, Double Blind, Bio Equivalency study on the Effects of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathic Pain. A Phase IV, Randomized, Placebo Controlled Trial of Pulsed Electromagnetic Fields on Shoulder Pain due to Impingement or rotator Cuff Injury. A Multicenter, Randomized, Pivotal Study to evaluate the safety and efficacy of the Cartilage Autograft Implantation System (CAIS) for the Surgical Treatment of Articular Cartilage Lesions of the knee.Oncology A Phase II/III, Randomized, Placebo Controlled Trial of XXXX and Bortezomib in Patients with Relapsed and refractive Multiple Myeloma. A Phase III Randomized Trial of XXXX plus Carboplatin vs. Carboplatin Monotherapy in Patients with Ovarian Cancer. A Phase II/III Randomized Trial of XXXX in Patients with Small Cell Lung Cancer. An Open Label, Randomized, Phase II/III Trial of Taxane Therapy With or Without Bavituximab for the treatment of HER2-Negative Metastatic Breast Cancer A Phase II/III Randomized Trial of Combination Chemotherapy Computer Planned Radiation Therapy in treating Patients with Unresectable Non-Small Cell Lung Cancer. A Phase III Randomized Trial of comparing Adjuvant Radiation Therapy Plus Hormone Therapy Compared with Radiation Therapy Alone in treating stage II/III Prostate Cancer Patients. A Phase II open label, XXXXX Monotherapy Efficacy study in patients with Acute Myeloid Leukemia with FLT-3 ITD Activating Mutations. A Double Blind, Phase III comparison of Dacomitinib and Erlotinib for advanced NSCLC after failure of Prior Chemotherapy. A Randomized, Double Blind, Placebo Controlled Trial of Neratinib (HKI-272) after Trastuzumab in Women with Early Stage 2 HER-2/neu Overexpressed/Amplified Breast Cancer A Phase III, Randomized, Controlled, Multi-Center, Open-Label Study to CompareTivozanib Hydrochloride to Sorafenib in Subjects with Refractory Advanced Renal CellCarcinomaEndocrinology A Phase II Randomized, Double-Blind Trial of XXXX for the Treatment of Juvenile Diabetes Mellitus. A Phase III Randomized, Placebo Controlled Trial of XXXX for Cardiac Outcomes in Patients with Diabetes Mellitus.Dermatology A Phase II Clinical Trial of XXXX for the Treatment of Patients with Imptigo and Secondary Infected Traumatic Lesions. A Phase III Clinical Trial of XXXX for the Treatment of Chronic Plaque Psoriasis. A Phase 3 Confirmatory Study Investigating The Efficacy and Safety of DUPILUMAB Monotherapy administered To Adult Patients with Moderate to Severe Atopic Dermatitis.Hematology A Phase IIb randomized, Double-blind, parallel group study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GBT440 in patients with Sickle Cell Disease. A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Effect of GBT440 on Hemolysis in Patients with Sickle Cell DiseasePain Management A phase 3, open-label safety study to evaluate TRV130 in patients with acute pain for which parenteral opioid therapy is warrantedUrology A Phase III Clinical Trial of XXXX in Male Subjects with Hypogonadism. A Phase III Open Label Clinical Trial of alpha 2 beta Interferon in Peyronies patients of at least 1 yr duration to assess effect on reduction of plaque, pain and curvature. A PHASE 3, Double-Blind, Randomized, placebo-controlled study of the safety and effectiveness of XXXXXX administered twice per treatment cycles (2x4) in men with Peyronies Disease An adaptive, Phase 2b/3, Double blind, Randomized Placebo controlled study to establish the Dosage, Efficacy and Safety of XXXX in treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naive male subjects.Infection Control A Phase III Randomized Clinical Trial of XXXX for the Treatment of Post Surgical Patients with Sepsis.Nephrology A Phase II/III Randomized, Double Blind, Placebo Controlled Clinical Trial of XXXX for the Treatment of Anemia in Patients receiving Kidney Dialysis. A Phase I Clinical Trial of XXXX for Wound Healing in Patients that have received Kidney Transplant. A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/BiomarkersRelated to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan ClinicalTrials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Women's Health A Phase III Clinical Trial of Low Dose Monophasic Combined Birth Control Patch in Women of Child Bearing Age.Cardiovascular A Phase III Randomized Clinical Trial of XXXX in the Treatment of Patients with Hypercholesterolemia. A Randomized, Double Blind, Parallel Group Study Of Cardiovascular Safety In Osteoarthritis or Rheumatoid Arthritis Patients With or at High Risk for Cardiovascular Disease Comparing Celocoxib With Naproxen and Ibuprofin.Pulmonology A Phase II/III Randomized Clinical Trial of XXXX for the Treatment of Patients with Asthma and Chronic Obstructive Pulmonary Disorder. A Phase III Randomized, Double Blind Trial of XXXX for Pediatric Patients with Hypertension.Vaccines A randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study inhealthy HIV uninfected adults to assess the safety/tolerability and immunogenicity of2 different prime/boost regimens; priming with trivalent Ad26.Mos.HIV and boosting withtrivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant OR priming with tetravalentAd26.Mos4.HIV and boosting with tetravalent Ad26.Mos4.HIV and Clade C gp140 plusadjuvant. A Phase III, Randomized, Single Blind, Multicenter Study to Evaluate the Safetyand Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent SubunitInfluenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated inTrials V118_05 and V118_05E1 A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safetyand Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent SubunitInfluenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated inTrial V118_0Rheumatology A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNF! Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy.CNS An Open-Label, Extension Study of the Effects of Leuco-methylthioniniumbis(hydromethanesulfonate) in Subjects withAlzheimer's Disease or Behavioral Variant Frontotemporal Dementia Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial ofLeuco-methylthioninium bis (hydromethanesulfonate) in Subjects withMild to Moderate Alzheimer's Disease A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safetyand Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjectswith Behavioral Variant Frontotemporal Dementia (bvFTD) Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safetyand Efficacy Study of Leuco-methylthioninium bis(hydromethanesulfonate) inSubjects with Mild Alzheimer's DiseaseEXPERIENCEClinical Research Facilitators, Atlanta, GA 2009 - PresentClinical Trial Manager, Lead CRA, Senior CRA Consultant W2- Performed Site identification, qualification and initiation for Medical Device and Drug Trials. Drug Trials include Phase 1, Phase 2, Phase 3, and Phase 4 clinical Trials.- Perform weekly and monthly metrics reports for Sponsor clients.- Team building and training for new clinical studies.- Responsible for the submission of essential documents to the Trial Master File. Responsible for the accuracy of the CTMS Central Files content for the study.- Responsible for specific trial CAPA program compliance.- Lead CRA for multiple projects, responsible for Review and Approval of Visit Reports, Site Assignments, Lead weekly Study Team Conference calls, Perform Observed visits for CRA's, Manage a team of 6 CRA's on new study, Participate in Client Update Meetings, Provide Weekly/Monthly Study Metrics for Clients, work with Data Managers to Maintain Central Files Submissions.- Worked with the Study Start Up Groups on all aspects of site preparation and site management.- Performed sponsor-initiated audits.- Reports, Central Files submissions, record retention, continuing education, and all other administrative aspects of the position in accordance with corporate guidelines and SOP's.- Attend investigator meetings and train site staff on protocols and duties for each of their specific clinical trials.- Preparation of study materials/tools, budget tracking and review of financials including advertising budgets, assembly of Master and Site Regulatory binders, monitoring report review, preparation of client deliverables, on-going client communication, assessment of site assignments to ensure maximum travel efficiency and responsibility and supervision of Central File Storage.- Worked with Chinas' State sponsored CRO to negotiate contracts and project deliverables for an international Osteoperosis study in Asian women.- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by management.Evaluate serious and non-serious quality complaints for Medical Devices in Clinical trials.Perform Quality Control reviews of clinical sites regarding 21 CFR Compliance.Audit of clinical sites regarding QC checks for missing Central Files informationWork with auditors during quality and compliance audits.Covance Princeton, NJ 2007 - 2009Lead CRA, Senior Clinical Research Associate II Consultant W2- Present study specific material to Investigator Meeting attendees.- Responsible for all aspects of site management as prescribed in the project plans- Responsible for all aspects of registry management as prescribed in the project plans- Undertake feasibility work when requested- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor.- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs- Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management- Assist with training, mentoring, and development of new employees, e.g. co-monitoring- Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned- Perform other duties as assigned by managementPAREXEL, Inc. Atlanta, GA 2006 - 2007Clinical Research Associate II- Site identification, qualification, and initiation- Included working with the Study Start Up Group on all aspects of site preparation- Performed interim monitoring visits throughout the country as well as termination and Close Out visits- Reports, Central Files submissions, record retention, continuing education, and all other administrative aspects of the position in accordance with corporate guidelines- Attend investigator meetings and train site staff on protocols and duties for each of their specific clinical trialsWalter B. Morley Research Foundation Atlanta, GA.2004 - 2006Project Manager - Regional Clinical Research Associate- Taking a subordinate role for project activities related to monitoring function- Site selection, training and managing site personnel, subject waivers, device and drug master accountability logs/reports, monitoring visits as well as close out visits.- Interfaced with Sponsor, IRB/ERC, Study Sites, as well as daily interaction with the clinical team, Project Management, clinical investigators, and other site personnel to ensure the quality and integrity of data and proper management of study parameters.- Preparation of study materials/tools, budget tracking and review of financials including advertising budgets, assembly of Master and Site Regulatory binders, monitoring report review, preparation of client deliverables, on-going client communication, assessment of site assignments to ensure maximum travel efficiency and responsibility and supervision of Central File Storage.EDUCATIONUniversity of Minnesota Minneapolis, MNBA, 1992PROFESSIONAL TRAINING HISTORYWellSolve CRA Level 1 Certificate Training Program. 12/2003PMP Academy Boot Camp Certificate Program. 4/2004CONTINUING EDUCATION SEMINAR / COURSESTherapeutic CRA training program completed: Does Regional Anesthesia Improve Outcome after Total Hip Arthroplasty? A Systematic Review Transfusion Strategy for Primary Knee and Hip Arthroplasty: Impact of an Algorithm to Lower Transfusion Rates and Hospital Costs Primary Knee Replacement: Management and Alternatives Total Knee Contact Pressures: The Effect of Congruity and Alignment Treatment of Articular Cartilage Defects of the Knee with Autologous Chondrocyte Implantation Tissue Repair Techniques of the Future: Options for Articular Cartilage Injury Primary Knee Replacement: Management and Alternatives Assessment of the Efficacy of Joint Lavage Versus Joint Lavage Plus Corticoids in Patients With Osteoarthritis of the KneePROFESSIONAL MEMBERSHIPS/HONORSAssociation of Clinical Research Professionals (ACRP)Regulatory Affairs Professionals Society (RAPS)Project Management Institute (PMI)Member of The Board of Directors for Bad Lands Productions (A Public Benefit 501 (c) 3 corporation)Publications'Building and Managing a Compliant and Successful Clinical Research Business' August 2017 |
