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Click here or scroll down to respond to this candidateCandidate's Name , Thornwood, NY 10594Sr. CRA/Clinical Trial Manager/Project Manager, Clinical Researchphone: PHONE NUMBER AVAILABLE; email: EMAIL AVAILABLESummaryOver 27 years of experience working in the clinical research industry with over 8 years as a Clinical Research Associate, 11 years as a Sr. CRA and 8 years as Project Manager/Lead CRA.Completing MPH (Epidemiology) at Mailman School of Public Health Columbia, course work completed currently doing field work anticipated completion 2022 Course work completedSimbec-Orion US, Oncology position was put on hold, no Regulatory support.Currently, AllSource Screening Solutions Agency Auditor FDA and active contributor to the CRF-Code of Federal Regulations Title 21 Mar 29, 2022 for Sponsors and InvestigatorsEducationUniversity of Hartford, West Hartford, Agency CT - Bachelor of Arts Degree, Major: BiochemistryHonorClinical Research Therapeutic Areas include:CardiovascularHyperlipidaemia with Metabolic Syndrome, Congestive Heart Failure, Essential and Malignant HypertensionAzor (amlodipine besylate) Diovan, (valsartan) Tiazac (diltiazern hydrochloride), Xarelto, Eliquis, Jardiance, and VericiguatDermatologicalAlopecia Areata, Eczema, Psoriasis, RosaceaDeviceDisposable Injectable to Treat Juvenile Diabetes (Now, Type-1 Diabetes) Insulin DeviceGastrointestinalGERD, Crohns Disease, Peptic Ulcer, Ulcerative ColitisInfectious DiseaseHepatitis A, BARDA productMental DisordersMajor Depressive Disorder, Bipolar, SchizophreniaMetabolic DisordersDiabetes Mellitus Types I, Pancreatic InsufficiencyMusculoskeletal & Connective Tissue DisorderWomens Health, Metastatic Bone Disease, OsteoarthritisNephrology/UrologyMens Health, Benign Prostatic HyperplasiaNeurology/UrologyDiabetic Neuropath, Migraine, Cluster HeadachesOncologyNon-Hodgkins Lymphoma, Colorectal Cancer, Glioblastoma Brain Tumor, Kidney Cancer, Hepatic Cell Carcinoma, Lymphoma, Metastatic Breast Cancer, Multiple Myeloma, Refractory Multiple Myeloma, Renal Cell Carcinoma, Myelodysplastic Syndrome, Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Peripheral T-cell Lymphoma, Small Cell Lung Cancer, CART-cell TherapyRegulatory ExperienceDomestic FDA and Europe EMA Pfizer, Inc. and Novartis, Inc.Recently, Simbec-Orion oncolytic Platform VCNRare DiseaseAcoustic NeuromaRespiratoryAdult mild asthma, Adult mild to moderate asthma, Adult Severe Asthma, Cystic Fibrosis (Pediatrics and Adolescent)VaccineInfluenza, Cervical Cancer in Young women Gardasil 9 MerckProfessional SkillsMicrosoft certified, Published in Peer review Journals and working knowledge of PM tools that include AGILE and Waterfall methologies to effectively implement PM directives. Coding for application to clinical documentsand the statistical mining of clinical data 3-5 yrs. Experience with Waterfall and Agile for methodology troubleshooting.Know Changepoint as it is related to Drug Safety. And negotiation of site-specific contractual agreement and budgets related to the specific protocol and/or study with institutions and large and single group practices.Experience in Electronic Data Capture TrialsProficient REDCap, Medidiata RAVE. Medrio, Oracle Inform,Research Manager and Bioclinica EDC and experience with EDC software users: sites, sponsor and CROsStatistical Software Knowledge IncludesExperience in functional activity withGrantManager and functional use of Grant-Plan. In addition knowledge SAS, R. Python and a keen understanding of how AI can purge systems for important and meaningful informationand AI can be a catalyst for building a change-ready culture using a Deep-Learning Model, most especially clinical study budgets, the new paradigm.Efficient in Coordinating allaspects of housekeeping documentation from study-start-up throughout the studyThrough understanding of the ICH-GCP guidelines and contributor to the Federation code-21. Proficient in all Microsoft applications including, WORD, TEAMs, Outlook Power-point applications, and very proficient in Excel and all electronic data capture systems, see above. Also, proficient with XIM to capture study related deviations andPharma safety review and led the group with toward new pharma safety trends.Supply Chain Experienceand Device experienceSupply chain related to protocol specific entity, biologicimmuno-therapy, oncolytic platforms, Gene Therapy,CRISPR, and Serum DNA and RNA liquid tumour biopsies.Biosimilar inspection audits for Biologics, ICIs, ADC, and CAR-T. Finally, for Devices via immune-assays recently Siemens, and recently PMCF experience with EUMDR on device requirements for the CI-1900 on the Atellica ProjectRecently, API inspection in the biological process of production in pharmacology process.Vendor Oversite Activitywith the following sponsors/CROs total experience 10 yrs.:Pfizer, Inc, Incyte, Inc. Sarah Cannon, BMS, Genentech, Inc. Simbec-Orion CRO an Parexel. Inc, CRO, Siemens-Healthineers, Inc.Providing guidance and support activities within Global Development Operations [GDO] to team members for all vendor oversight processes according to ICH E6 (R2) standards. Support standardization of vendor oversight requirements and reporting readying organization for Inspection Preparedness Training and development curriculum of all processes related to vendor oversight for involved staff to ensure adherence and efficient execution of activities. Drive communication and training for GDO vendor oversight in support of due diligence and assessment processes. IT experience with Brightcove and Agile and Brightcove and other venues and applications planning and implementing and TEAM player.Publications AvailablePeer-Reviewed Journals available upon requestProfessional Experience:ALLSource Screening Solutions (Assigned to the FDA Sr. CRA/Auditor Oncology studies Independent Contractor FDA(December-January personal leave caring for mother who had Cancerand passed early February) January 2023-PresentEnsure the study staff who will conduct the protocol have received the propermaterials and instructions and to safely enter patients into the study.Assuring that all essential components that the FDA want to see are available for review for study-start and comply to sponsors SOPs and meets Regulatory requirementsand assuring equipment calibration via IQ, OQ and PQ with documentation reviewProject management capacity as an auditor delegating responsibilities and rolesAssuring subject/patient recruitment is adhering to regulatory guidance(s)Implementing the FDA criteria and guidance documents for assessing correct audit procedures including aseptic and data integrityrelated to the GMP of equipment and SOPs are to be followed.Ensure the protection of study patients by verifying that informed consentprocedures and protocol requirements are adhered to according to the applicable regulatory requirements.Ensure the integrity of the data submitted on Case Report Forms (CRFs) or otherdata collection tools by careful source document reviewed.Assuring the chain of command of the sponsor is in delivery of all aspects of any study that is facilitated through the proper SOPsAssuring that the formal process to use in attempting any resolution is implemented via the proper chain of command always assuring patient safetyAssuring effective communication at all levels is essential for the proper implementation of the chain of command in a clinical studyEnsure that the implementation of ICH-GCP guidelines is/are executed per the sponsor and protocol/study.Using the FDA matrix required assessment tools to appropriately assess performance and implementation by the sponsor.Review Regulatory documentation for status review.Auditing manufacturing facilities for EU Annex I, !, and III reviewing specific guidance on the manufacturing of medicinal productsat pharmaceutical site or device manufacturing site.Auditing for Type II diabetes Lilly therapy Mounjaro and its effect on of weight loss a finding and safety profileVery knowledgeable in conducting FDA audits and and denoting what the FDA is emphasizing safety and most especially Regulatory housekeepingVery adapted in descriptively writing CAPAs using the Code of Federal Regulations guidelinesAuditing all component parts of a hospital or practice setting where the clinical study is being conducted,assuring Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Monitoring Practice, Good Manufacturing Practical, if applicable according to FDA RegulationsGreatest attribute TEAM player as part of the Clinical TeamAlso, very familiar with Global Transparency Regulations via Policy Article 74 of the Regulation EU No. 536 2014 in my recent audits.InfoTree Inc. Agency (on assignment with Siemens-HealthCare Diagnostics)September2022-Nov2022Contractor, Sr. CRA September-2022-November-2022-3-month contractThree-month contract to complete protocol for the CI-1900 instrumentSelect CRO to conduct monitoring of the Linearity and Detection Limitation on the CI-1900at one single site Germany on the CI-1900Create a Communication Plan for the CRO Nexus as the Project management related to delegated responsibilitiesAssuring that all implementation of ICH-GCP guidelines is execute with and by the CRO NexusAll study start-up material and specifications have been complied too by the sponsor SOPsChain of command supply of immunotherapy application to an automated system from beginning in establishing Ex-cell real time spread sheets shares on Microsoft TEAMs with TEAM membersPOC with FDA to assure the chain of command was indeed compliance with ICH-GMPPOC of contact with vendors on bedding of needed products and product material and assure chain of supply was intact with primary and secondary vendors.All Regulatory documentation has been executed and current for expectation ready by the sponsor and the Regulatory Agency (FDA)POC for PMCF for the Atellica Project CI-1900 to the European Union Medical Device Regulations continued from previous assignment on Nov. 2021Understand IC Software associated with device updating and preparation on the Atellica project.Understand EU MDR regulations in the preparation potential Siemens-Healthcare for TEAM review prior to submission to upper management.Also, part of a TEAM that was involved in the new and updating of labelling product presentation.Simbec-Orion (CRO)Nov-2021-Dec-2022Contractor, CTL, PM Nov 2021 Contract ended extension 2-months.Contractor responsibilities included managing the planning, implementation, and tracking of the clinical monitoring process. Maintains an overview of ongoing taskswithin Clinical Operations department, and the Sponsor. Had a significant role in ensuring deadlines of projects are met in accordance with contracted scope of work, budgeted hours whist ensuring maximum efficiency and quality.Responsible for oversight of CRAs and IHCRAs activity on the assigned study.Assuring that all TEAM members contribute to all aspects of Study-Start-up for a seamless launch assuring all aspects of SOPs have been implementedVery knowledgeable with Veeva Vault as the reporting formatReviewing patient/subject recruitments profiles via regulatory requResponsible of Preparation, maintenance and execution of Clinical Operating plans.Ensures study team receives study specific training according to Simbec-Orion SOPsEnsures all monitoring tasks are delivered on-time within agreed monitoring.Communicates progress and assist project with tracking of project status.Assist or assure that with budgeting throughout the project and forecasting of URFs.Contributes to regular updates to Clinical Trail System.Act as a CRA on the project, where necessary.Assuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedAssuring the site has been properly trained with the EDC system use via Medidata RAVEOversight of many housekeeping administrative aspects of the clinical study from Regulatory documentation completion to assuring the site was audit ready.Including setting up a Microsoft Teams chat portal directly with sites for the study coordinator and PI on directly address study related issues.Chain of command supply of immunotherapy application to an automated system from beginning in establishing Ex-cell real time spread intro shares on Microsoft TEAMs with TEAM membersPOC with FDA to assure the chain of command was indeed compliance with ICH-GMPPOC of contact with vendors on bedding of needed products and product material and assure chain of supply was intact with primary and secondary vendors.Understanding of Global Transparency Regulations due to the Oncolytic Platform introduced by VCN, Spanish biotech company.InfoSoft Inc. Agency (on assignment with Siemens-HealthCare Diagnostics)July 2021-Nov 2021Contractor, Sr. CRA, TLC, PMEnsure the study staff who will conduct the protocol have received the propermaterials and instructions to safely enter patients into the study for study start-upPM to third party vendorsEnsure the protection of study patients by verifying that informed consentprocedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or otherdata collection tools by careful source document reviewMonitor data for missing or implausible dataCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assignedWorking closely with engineers in adapting the biologic maker to anticipated lab valuePreform other duties as assigned by managementUploading and troubleshooting oncology immunoassays on the CI-1900 instrument to increase the machine menuAssuring the site has been properly trained with the EDC system use via InformAssuring that all implementation of ICH-GCP guidelines is executedOversight of many housekeeping administrative aspects of the clinical study from Regulatory documentation completion to assuring the site was audit ready.Including setting up a Microsoft Teams chat portal directly with sites, for the study coordinator and PI to directly address study related issues.Chain of command supply of immunotherapy application to an automated system from beginning in establishing Ex-cell real time spread sheets shares on Microsoft TEAMs with TEAM membersPOC with FDA to assure the chain of command was indeed compliance with ICH-GMPPOC of contact with vendors on bedding of needed products and product material and assure chain of supply was intact with primary and secondary vendors.All Regulatory documentation has been executed and current for expectation ready by the sponsor and the Regulatory Agency (FDA)POC for PMCF for the Atellica Project CI-1900 to the European Union Medical Device RegulationsPlanet Pharma Agency (on assignment with Covance Inc.), Durham, NC, USA
Jan 2021 Jun 2021Contractor, Senior Clinical Research Associate II, CTL and Project ManagerThe below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and dutiesResponsible for all aspects of study site start-up monitoring including the maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assignedResponsible for all aspects of site management as prescribed in the project plansGeneral On-Site Monitoring Responsibilities:Project manager role of delegating responsibilities analytics can identify highEnsure the study staff who will conduct the protocol implementatin has received the proper materials and instructions and training to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewMonitor data for missing or implausible dataEnsure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policyManage small projects under direction of a Project Manager/Director as assignedServe as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assignedParticipate in the development of protocols and Case Report Forms as assignedUnblinded CRA for a phase II/III Oncology studyParticipate in writing clinical trial reports as assignedInteract with internal work groups to evaluate needs, resources and timelinesAct as contact for clinical trial supplies and other suppliers (vendors) as assignedNegotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assignedIndependently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by managementAssist with training, mentoring and development of new employees, e.g., co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assignedPerform other duties as assigned by managementAssuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedAssuring the site has been properly trained with the EDC system use via Medidata RAVEChain of command supply of immunotherapy application to an automated system from beginning in establishing Ex-cell real time spread sheets shares on Microsoft TEAMs with TEAM membersPOC with FDA to assure the chain of command was indeed compliance with ICH-GMPOversight of many housekeeping administrative aspects of the clinical study from Regulatory documentation completion to assuring the site was audit ready.Including setting up a Microsoft chat portal directly with sites for the study coordinator and PI to directly address study related issues.ICON Clinical Research (Pfizer, Inc. Vaccine COVID-19)September 2020 December 2020Senior Clinical Research Associate, CTL, PMIdentify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate.Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.Monitoring COVID-19 Pfizer, Inc. Vaccine all EAST coast region sitesAssuring that all implementation of ICH-GCP guidelines is executedAssuring that the site understands the protocol and proper training has been conductedAssuring the site has been properly trained with the EDC system use via RAVEAssuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedOversight of many housekeeping administrative aspects of the clinical study from Regulatory documentation completion to assuring the site was audit ready.Including setting up a Microsoft chat portal directly with sites for the study coordinator and PI to directly address study related issues.Aerotek, Inc. (Sarah Cannon)November 2019 to March/April 2020 (Furloughed, due to COVID-19)Senior Clinical Research Associate, CTL, PMIdentify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, per Sarah Cannon or sponsor SOPs/WPs, applicable regulations and the principles of ICH-GCP Guidelines Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of Sarah Cannon or Sponsor systems and procedures as appropriate.Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.To oversee the proper execution of study-start-up to assure a timely execution to meet timeline.Renal study of Hypophosphatemia and electrolyte disorder resulting in the low levels of phosphate in the blood resulting rhabdomyolysisAssuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedAssuring the site has been properly trained with the EDC system use via Medidata RAVEOversight of many housekeeping administrative aspects of the clinical study from Regulatory documentation completion to assuring the site was audit ready.Chain of command supply of immunotherapy application to an automated system from beginning in establishing Ex-cell real time spread sheets shares on Microsoft TEAMs with TEAM membersPOC with FDA to assure the chain of command was indeed compliance with ICH-GMPIncluding setting up a Microsoft chat portal directly with sites for the study coordinator and PI to directly address study related issues.PAREXEL, Inc.August 2016 to October 2019Senior Clinical Research Associate Clinical ->Trial Manager-> Project ManagerConducted the clinical monitoring aspect of designated projects from study start-up through phase I, II and III assuring proper executionPerformed clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection).Project Manager for two studies for a sponsor related to ADHD and Psychosis and bipolar disorders.Biomedical Advanced Research and Development Authority (BARDA) begin process for potential Clinical study potential infectious disease studyBegan working with Rick Bright formerly director at BARDA began the process on establishing mRNA vaccines, establish all the Regulatory documents and processes.Assuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedAssuring the site has been properly trained with the EDC system use via Medidata RAVEOversight of many housekeeping administrative aspects of the clinical study from Regulatory documentation completion to assuring the site was audit ready.Including setting up a Microsoft chat portal directly with sites for the study coordinator and PI to directly address study related issues.Chain of command supply of immunotherapy application to an automated system from beginning in establishing Ex-cell real time spread sheets shares on Microsoft TEAMs with TEAM membersPOC with FDA to assure the chain of command was indeed compliance with ICH-GMPPOC of contact with vendors on bedding of needed products and product material and assure chain of supply was intact with primary and secondary vendors.PM for multiple studies in Oncology, listed below.Study Assignments (Incyte)August 2016 to October 2019Clinical Trial ManagerA Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of a Cancer Biologic in Combination With SOC In Selected CancersStudy Sites handled: USA. (4 Sites)Unblinded CRA for Early phase II Oncology studyTo assue Study start-up stages are addressed handled and executed: Initiation, Monitoring, addressing Safety issues query documentation and resolution through, Closeout VisitsTrial Master File reconciliationAssuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedAssuring the site has been properly trained with the EDC system use via Medidata RAVEOversight of many housekeeping administrative aspects of the clinical study from Regulatory documentation completion to assuring the site was audit ready.Including setting up a Microsoft chat portal directly with sites for the study coordinator and PI to directly address study related issues.Worked very closely with in-house CRAs to assure the study related documents are properly completed and current.Chain of command supply of immunotherapy application to an automated system from beginning in establishing Ex-cell real time spread sheets shares on Microsoft TEAMs with TEAM membersPOC with FDA to assure the chain of command was indeed compliance with ICH-GMPPOC of contact with vendors on bedding of needed products and product material and assure chain of supply was intact with primary and secondary vendors.Study Assignments (Celgene)Senior Clinical Research AssociateAugust 2016 to October 2019Phase I/II study Open-label multicenter study Evaluating XXX In Patients with Hematologic MalignanciesStudy Sites handled: USA. (6 Sites)Study stages handled: Study-Start-up, Site Initiation, Monitoring, Closeout Visits, SWAT CRA, Risk-Based Monitoring, Trial Master File reconciliationAssuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedAssuring the site has been properly trained with the EDC system use via Medidata RAVEOversight of many housekeeping administrative aspects of the clinical study from Regulatory documentation completion to assuring the site was audit ready.Including setting up a Microsoft chat portal directly with sites for the study coordinator and PI to directly address study related issues.Worked very closely with site coordinators to assure the study related documents are properly completed and current for both sponsor and Regulatory inspectionStudy Assignments (BMS)Senior Clinical Research AssociateAugust 2016 to October 2019A Phase I/Ib, Open Label Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, pK and Antitumor of the anti-PD-1 Monoclonal antibody OPDIVO in combination with the PARP inhibitor Olaparib in Subjects with Advanced Solid TumorsStudy Sites handled: (6 Sites) USAStudy stages handled: Study start-up, Site Initiation, Monitoring,Patient Evaluation/EligibilityTrial Master File reconciliationAssuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedAssuring the site has been properly trained with the EDC system use via InformWorked very closely with site coordinators to assure the study related documents are properly completed and current for both sponsor and Regulatory inspectionStudy Assignments (Acetylon/Celgene)August 2016 to October 2019Senior Clinical Research AssociateA Phase I/Ib, Open Label Multiple Dose, Dose EscalationStudy to Determine the Maximum Tolerated Dose, Safety and Efficacy of ACY-1215 in combination with Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed-Refractory Multiple MyelomaResponsibilities:Study Sites handled: (4 sites) USAStudy stages handled: Site Initiation, Monitoring,Patient Evaluation/Eligibility, CRATrial Master File reconciliationAssuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedAssuring the site has been properly trained with the EDC system use via InformWorked very closely with site coordinators to assure the study related documents are properly completed and current for both sponsor and Regulatory inspectionGlobal Employment SolutionsMarch 2016 to August 2016Senior Clinical Research Associate, Study Assignments (PreCog/NIH)A Phase III study of Velcade in Combination with Vincristine, Doxorubicin, and Dexamethasone Versus VAD in Patients with Relapsing or Refractory Multiple MyelomaResponsibilities:Study Sites handled: (2 sites) USAStudy stages handled: Site Initiation, Monitoring,Patient Evaluation/EligibilityTrial Master File reconciliationAssuring that the site understands the protocol and proper training has been conducted.Assuring that all implementation of ICH-GCP guidelines is executed.Assuring the site has been properly trained with the EDC system use via Inform.Worked very closely with site coordinators to assure the study related documents are properly completed and current for both sponsor and Regulatory inspectionCCS Associates IntlSeptember 2015 to March 2016Senior Clinical Research Associate, Study Assignments (PreCog/NIH)A Phase III study of Pomalyst in Combination with Vincristine,Doxorubicin, and Dexamethasone Versus VAD in Patients with Relapsing or Refractory Multiple MyelomaResponsibilities:Study Sites handled: (6 sites) USAStudy stages handled: Site Initiation, Monitoring,Patient Evaluation/EligibilityTrial Master File reconciliationAssuring that the site understands the protocol and proper training has been conductedAssuring that all implementation of ICH-GCP guidelines is executedAssuring the site has been properly trained with the EDC system use via InformKPS Life, LLCSeptember 2014 to September 2015Senior Clinical Research Associate Study Assignments (BMS)Randomized, Open-label, |
