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Click here or scroll down to respond to this candidateCandidate's Name ,CRA 2010 W.Cheltenham Ave Philadelphia,PA 19138Cell:Street Address -989=5493Email:EMAIL AVAILABLECareer objective: I possess a diverse and strong background in the medical field in clinical research, having worked in various roles such as Oncology/Hematology, Neurology & Vaccines maintenance research clinical trials. I served as an In-House & traveling monitor as well a recent role as an Assistant Operation Supervisor. Skilled in Phase 1-4 research facility, In house monitor at a reputable hospital/university institute. I have worked as a contract CRA/consultants when needed. My experience encompasses physician-initiated trials, industry trials, and academic trials where I have collaborated with renowned P.I, as a traveling CRA,carry out selection, initiation, monitoring and close-out visits at the participating clinical trial centers, also for logistics and coordination of the study, Ive monitor the study to check whether it has been carried out in accordance with applicable laws and regulations develop study procedures, methodology and instructions for clinical trials staff, as well as design data collection tools, case report forms, manage study supplies, managed study medication supplies, and medication accountability, collect, verify and finalize collected to create reports and present results of findings to other medical staff, most importantly ensure the safety and well-being of test volunteers well liaising ethics committee.Research Skills:Clinical trials 22 yrs.CRO/SMO experience.Clinical Trials in Phase I-4 &.Phase Ia&IIbEvents (SAE) report, continuing review reports, and other reports submitted to theInstitutional Review Board (IRB). Review submissions prepared by staff to ensure that all submissions meet established standards.Oversees case report form completion performed by staff for all studies and assists in the coordination of audits by the study sponsor monitors.Exposure to various therapeutic areas, both in research and safety issues audits.Trained in ICH/GCP,FDA & GMP guidelines regulation protocol submission.Ability to recruit and screen study participants as well develop screening tools.Committed to quality patient care as well frequently recognized by physicians for strict attention to detail, patient advocacy and decision-making abilities in critical situations.Knowledgeable of on-going regulatory and IRB phases and IND safety reporting.Monitor project activity, schedule training visits, and maintain training records.Reviewed regulatory documents according to ICH/GCP & FDA guidelines and 21 CFR.Resolved data discrepancies and ensured complete and accurate data by reviewing source documents incorporating quality control.Provided data clean up support to clinical research clinics data reviewer, validation cleanup, quality control assurance.Reviewed and obtained informed consents.Packaged and shipped PK samples and other laboratory samples under IATA guidelines.Participated in quality improvement initiatives,reviewed&create SOPs, and reviewed monitoring reports.Experience in various Medical Devices(lung function analyzer, Pulse wave velocity, Freeze Framer, euro sensory testing,thermometer,IV infusion pumps, and cardiac markers.In-house monitoring Albert Einstein Medical Center, Emergency Medicine Department.It involves selecting vendors, based on criteria, such as experience and cost managing the relationship, monitoring their performance, and evaluating their performance during and after a clinical trial has been completed having an effective vendor management strategy in place can help reduce costs associated with a clinical trial and improve overall patient safety.Vendor management is an essential part of clinical research and is a critical component of the entire clinical trial and the process involves the selection of vendors, the qualification of vendors, the management monitoring, and the regular evaluation of vendors.This includes setting expectations for the vendor, addressing any conflicts that may arise between the vendor and the sponsor or investigator, and ensuring that all contracts are up-to-date and compliant with applicable regulations.Therapeutic Area:(Neurology)On-Site monitoring for anti-inflammatory aspects of Parkinsons disease patients immune system for which the goal of this study is to identify blood-based immune markers that can be used as a potential diagnostic marker of disease progression.(Rheumatology)Screen subjects with active Rheumatoid Factors based on Inclusion and Exclusion criteria which consist of one anti-TNFa,DMARDS,CRP,as well biologic for possible enrollment into our Clinical Trials.(Pulmonary)Recruit study participants with active COPD,Emphysema,and Bronchitis, moderate to severe Asthma, perform Pulmonary Function test, with treatment, and observe study participants for adverse events.(Gastrointestinal)Collect study specimen from NG tubes and perform test against Gastro Cult for active results, provide results to Attending Physicians.(Dermatology)Collected data and evaluate IND from study participants with severe or moderate Plaque Psoriasis, Alopecia.(Oncology/Hematology)Manage 4 oncology sites and study coordinators. Trained staff in RECISIT criteria Growth Factors TNFa and T cells(Vaccine Moderate, Vaccine Pfizer),COVID 19,&influenza).Unblended Dose preparation and post dose, followed by doing patients. Confirm BPO,IP Request,DPW,followed by drug accountability, verification into Endpoint validation and confirmation of IP.Research Qualification:Clinical Operations Supervisor IBiologic Scientific Research Institute SMO LLC03/2020 to 04/2024Philadelphia, PAAs the Operations Supervisor for a Phase 1 facility, my duties included the following:Ensuring that all team members were trained appropriately to perform their tasks, oversaw numerous clinical trials with over 100 participants,hired,trained,and assisted staff where needed to carry out the many tasks involved in Phase I-4 trials. I made sure to comprehensively address all aspects of the trial on a daily basis also covered any areas that were overlooked or understaffed during days when doses were scheduled, timing was crucial. If we were understaffed, I would step in and administer doses to subjects. Additionally, I offered support with phlebotomy,vitals,ECG,and other protocol-related procedures that were necessary on certain days to guarantee that everything was in order and adhered to protocol requirements. Attended all protocol meetings, training sessions, and other related events to provide guidance to staff and clear up any misunderstandings of the protocol or trial processes. I trained staff to ensure timely completion of new trials according to protocol requirements. Conducted quality assurance and quality control checks on all charts and source documents daily.Contract(Clinical Research Associate)02/202001/2021Corporal Michael J.Crescenz VA HospitalClinical Research NeurologyPhiladelphia, PAMaintain contract with the sites and remotely monitor compliance issues on an ongoing basis,. Perform site visit from selection to closeout, long term management of site via interim, monitoring visits Assisted in the design and oversight of project monitoring services including training site patient recruitment, site/document management, monitoring project site budgets and regulatory filings that align with SOPs study guidelines and GCP best practices as well, compliance with overall study timelines to maintain recruitment progress, data cleaning and appropriate IMP management, and provide, evaluate and ensure patient data quality and scientific integrity of clinical trials.Contract(Clinical Research Associate11/2016 -02/2020Corporal Michael J.Crescenz VA HospitalClinical Research NeurologyPhiladelphia, PACoordinate Clinical Trials, visit trial sites regularly. Acts as liaison between project manager and research-site personnel. Prepare final reports and occasionally manuscripts for publication. Identify/select an investigator who will be responsible for conducting the trial at the trial site, set up the trial sites-ensuring each site has the trial materials, including(IMP),train the site staff to trial-specific industry standards, monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis verify that data entered on to the CRFs is consistent with patient source documents for(SDV)verification.L(Contract)Clinical Research Associate06/201509/2016ICON ResearchClinical ResearchNorth Wales, PAResearch information materials needed for the study start-up, such as identification verification of potential sites for clinical trials, review feasibility questionnaires obtained from the site to determine whether the sites meet the study requirements, provide support for the proposal bid defense for the study start-up process, as well collect the required investigator and regulatory documents for study and ensuring that the documents meet specifications required by,ICH/GCP,&FDA regulations(for IND studies)prepare investigator initiation packets, ensure each sites has the trial materials.(Contract)Clinical Project Coordinator04/2014-03/2015BTG CROClinical ResearchConshohocken, PAResponsibilities include monitoring reports, protocol deviation & data listing for sponsor studies to ensure reliable quality data are delivered, assist project managers with e-TMFforms and data validation, QA/QC EDC, review language & draft study protocol, patient informed consents, & drafts safety drug orders forms.(Contract)Clinical Project Leader10/201206/2013BTG CROClinical ResearchConshohocken, PACoordinated and implemented the feasibility, setup,budgeting,initiation,supervision of monitoring and closures of PHASE I-IV studies, assisted project mangers in trial budget and contracts at local level.Assistant Site Director06/201009/2012Global Research Institute SMOClinical Research OncologyMiami Beach, FLTravel to Oncology sites, management of 8 CRAs and 1 CPA to perform all study related activities from feasibility to study closure, development plans and evaluation of unexpected AEs & SAEs, prepare regulatory documents for Sponsors/CRO's prepared investigator agreement, financial disclosure, curriculum vitae, IRB/IEC membership, lab-related documents, delegation of authority, site signature log, prepare for and respond to internal and Sponsor/CRO's audits, regulatory inspection, & obtain study summary and close-out letter for IRB/IEC/Sponsor/CRO's,knowledge with vendor management a essential part of clinical research and is a critical component of the entire clinical trial and the process which involves the selection of vendors, the qualification of vendors, the management monitoring, and the regular evaluation of vendors.Database Skills:*Proficient computer skills with Windows, Microsoft Word,Excel,PowerPoint,OMD,CLIN trials Database, CLIN Access and Lotus Note,IMPACT,e-TMFORACLE (TAO)Macro, Micro Remote Electronic Data Capturing, Inform Data Capturing,Medidata, Phase Forward, Rave EDC,Rave X EDC,INFORM 3e-Clin Trials Stat, CLIN Capture & OC-RDC Florence,Longboat,CRIOEducation:Pending Maters Degree10/15/2023ASUBiochemistryTempe, AZDiploma Received09/05James Adams High SchoolAcademic StudiesMiami, FLB.S.Received(01/11)Davidson CollegeBiologyDavidson, NCCertification:*NCCT Phlebotomy, Basic Life Support,ECG,Medical Terminology,Anatomy&Physiology,Vitals,OSHA,& IATA Certified, Psychology Rater, Alzheimers& Dementia MMSE,GCP Certified.Reference: Available Upon Request/Willing to Relocate |
