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Click here or scroll down to respond to this candidateCandidate's Name
CLINICAL RESEARCH PROFESSIONALEMAIL AVAILABLEDallas, TXSUMMARYExperienced Clinical Research Associate with 5 years of working with CROs and Sponsors in new drug development monitoring clinical research studies with on-site and remote monitoring visits. Experienced in the utilization of clinical oversight/tracking tools for patient study treatments, patient safety and financial payments. Excellent communication and writing skills. Thorough knowledge of FDA, ICH and GCP principles and regulations. Proven ability to exercise independent judgement and use of critical thinking to analyze problems. Proven skills in performing clinical site visits and resolving problems with subject eligibility, EDC database queries, protocols or study procedures. Therapeutic history includes Addictions, Cardiovascular, Dermatology, Oncology, Oral Care, Medical Device, Metabolic, and Urology studies.SKILLS & ABILITIESSite Management, Monitoring Visits, Patient recruitment strategies, Data evaluation, Patient safety reporting, Trip/Monitoring reports, Action planning, Team training, Coordinating supplies, Status reporting, Microsoft Excel. Word, Power Point, SAP, SAS, Medrio, IMedidata (RAVE), ClinFlash, eTMF, small animal surgery, balloon catheter techniqueEXPERIENCEClinical Research Associate/Regulatory Affairs Specialist 11/2022 Present Global Effect Therapeutic Consulting LLC, Frisco, TX Contract Negotiation for new business opportunities Providing monitoring services for sponsors and CROs on Clinical trials to ensure Study Protocol, GCP, ICH guidelines and Regulatory Compliance Regulatory and Medical Writing services Valid Drivers License, US Citizen and able to travel Nationally Clinical Research Associate ll 2/2021 10/2022Tigermed America LLC, Remote, Fort Collins, CO Conducted on-site and remote monitoring visits in compliance with ICH-GCP, SOPs, Local Laws and Regulations, Protocol and project-specific monitoring plans. Managed studies as primary site contact and site monitor throughout all phases of a clinical research study, taking responsibility of allocated sites. Developed strong site relationships and maintained them throughout all phases of trials. Communicated with Site investigators and their staff, and ensured compliance with protocols, regulatory requirements, and good clinical practices. Provided regular reporting on project metrics, status of deliverables and risks/issues with the associated management plans to the sponsors in a timely manner to successfully meet deadlines. Lead and direct internal cross-functional team members and third-party vendors. Guided and supported team members in identifying and analyzing risks, prioritizing, troubleshooting and contingency planning. Participated in site selections, initiations, monitoring, co-monitoring, and closeout visits. Ensured adherence to company SOP, policies and guidelines at the project level. Performed on-site data verification, data integrity and monitor CRF completion and queries. Several years of Oncology experience Regional and National On-Site monitoring within the USA along with Remote monitoring. Travel was based on number of Studies assigned to, Number of Sites and Monitoring frequency plan. Updated a Sponsors Pharmacy Manual to make the Oncology IP preparation clearer. Updated an SOP to help increase the efficiency for completing study start-up documentation. Served as back-up CRA for colleagues and their studies per team plan. Completed studies from study initiation to study close out. Attended weekly Sponsor/Study Team meetings. Requested missing essential documents from Sites for eTMF. Verified the integrity of investigator files, ensured the availability of clinical and non-clinical materials, maintained the required documentation in the Trial Master File according to the company standards and applicable guidelines, and checked for consistency with the contents of sponsor files. Recruited Physicians and Sites to participate in new Clinical Research Studies. Served as Start- up CRA and Back-up CRA while managing studies as a Monitor. Clinical Research Associate/Regulatory Affairs Specialist 6/2019 1/2021 Global Effect Therapeutic Consulting LLC, Frisco, TX Conducted on-site and remote monitoring visits in compliance with ICH-GCP, SOPs Local Laws and Regulations, Protocol and project-specific monitoring plan. Managed studies as primary site contact and site monitor throughout all phases of a clinical research study, taking responsibility of allocated sites. Developed strong site relationships and maintained them throughout all phases of trials. Communicated with Site Investigators and their staff, and ensured compliance with protocols, regulatory requirements, and good clinical practices. Addressed non-conformances and change controls to offer regulatory affairs updates to QA metrics. Reviewed the site regulatory binder to check collection procedures and completeness of paperwork. Reported to project manager for issues related to overall study status. Monitored site activities and sent follow-up letters to sites and completed Monitoring Visit Reports according to established metrics. Led Department training for staff. Performed drug and/or device accountability Performed source documentation verification/review in accordance with Sponsor Protocol and Monitoring plan.Clinical Research Associate 9/2017 12/2019Bracane Company (CRO), Plano, TX Conducted on-stie and remote monitoring visits in compliance with ICH-GCP, SOPs Local Laws and Regulations, Protocol and project-specific monitoring plan. Addressed non-conformances and change controls to offer regulatory affairs updates to QA metrics. Managed studies as primary site contact and site monitor throughout all phases of a clinical research study, taking responsibility of allocated sites. Developed strong site relationships and maintained them throughout all phases of trials. Developed and updated Pharmacy and Laboratory Auditing Standard Operating Procedures(SOPs) for FDA/CDER. Communicated with Site Investigators and their staff, and ensured compliance with protocols, regulatory requirements, and good clinical practices. Reviewed the site regulatory binder to check collection procedures and completeness of paperwork. Reported to project manager for issues related to overall study status. Monitored site activities and sent follow-up letters to sites and completed Monitoring Visit Reports according to established metrics. Led Department training for staff. Performed drug and/or device accountability Performed source documentation verification/review in accordance with Sponsor Protocol and Monitoring plan. Checked electronic data capturing system for integrity and compliance. Evaluated proof of eligibility and consent for participants. Obtained site approval and compiled all essential documentation. QA Sr. CHEMIST/GMP AUDITOR 2000 - 2016COLGATE ORAL PHARMACEUTICALS, Division of Colgate Palmolive, Dallas, TX Supported the Global Analytical Services and Research and Development Teams with testing marketed and newly developed dental products for compliance to product specifications. Ordered Equipment and managed the Validation of Lab and Microbiology equipment. Managed the Preventative Maintenance and Calibration Program for Analytical and Microbiology Lab Equipment. Authored equipment protocols for Installation Qualification(IQ), testing for newly developed products prior to their commercial release. Supported Sites in Maine, Texas, Canada and Tennessee utilizing my Analytical testing expertise. 4 years managing on-site/remote QA/GMP audits/inspections ensuring compliance with FDA and other health authority regulations/guidelines, site SOPs, protocols and standards. Reviewed Batch Records and Labeling for Product Compliance. Prepared clear and concise written reports of audit observations including an assessment of compliance. Evaluated the quality and integrity of site practices to ensure compliance and improved Facility Regulatory Inspection results to zero observations in 2015. Operational Qualification (OQ), and Performance Qualification (PQ). Performed Validation. EDUCATIONJanuary 2014 Master of Science: Regulatory Affairs Northeastern University School of Professional Studies, Boston, MAMajor: Regulatory Affairs for Drugs, Biologics and Medical DevicesGPA: 3.7Bachelor of Science: Psychology with Chemistry Related Studies Tufts University Medford, MAClinical Research Associate TrainingTigermed CRA AcademyBracane CompanyGCP Training CertificateContinued.Clinical Research ProjectsIndication Phase ResponsibilityAdvanced SolidTumorI, IICRA: Site Management, Monitoring visits, Product Reconciliation, Patient Safety, Data Evaluation, TMF Review, Equipment Calibration Review, Subject Recruitment Assessment, Site Communication, assessed product storage conditions and procedures to check adherence to protocol standards.CRA: Site Start up, Monitoring and Closure, IP Reconciliation, Patient Safety, Data Review, Deviation AE/SA review, Trip Reports, coordinating suppliesProstate CancerIICRA: Site Management, Monitoring visits, Product Reconciliation, Patient Safety, Data Evaluation, TMF Review, Equipment Calibration Review, Subject Recruitment Assessment, Site Communication, assessed product storage conditions and procedures to check adherence to standard protocols.CRA: Site Start up, Monitoring and Closure, IP Reconciliation, Patient Safety, Data Review, Deviation AE/SA review, Trip Reports, coordinating suppliesCardiovascularI, II, IIICRA: Site Management, Monitoring Visits, Product Reconciliation, Patient Safety, Data Evaluation, TMF Review, Equipment Calibration Review, Subject Recruitment Assessment, Site Communication, assessed product storage conditions and procedures to verify adherence to protocol standards.CRA: Site Start up, Monitoring and Closure, IP Reconciliation, Patient Safety, Data Review, Deviation AE/SA review, Trip Reports, coordination supplies.Dermatology -SunscreenIVCRA: Site Management, Monitoring Visits, Product Reconciliation, Patient Safety, Data Evaluation, TMF Review, Equipment Calibration Review, Subject Recruitment Assessment, Site Communication, assessed product storage conditions and procedures to check adherence to standard protocols.CRA: Site Start up, Monitoring and Closure, IP Reconciliation, Patient Safety, Data Review, Deviation AE/SA review, Trip Reports, coordination supplies.OpioidAddiction,RespiratoryDisorders,Oral CareIVCRA: Evaluated proof of eligibility and consent for participants. Checked EDC for integrity and compliance, source documentation verification, and maintained strict confidentiality to keep all personal information and collected data private.GCP Audit of On-Site Pharmacy and Laboratory.Chemist: Performed Analytical testing on the Active Ingredient for the comparison between an FDA regulated Prescription Mouthwash and a new non marketed Alcohol-free mouthwash and completed a Summary Report used in an ANDA submission.Breast CancerI, II, IIICRA: Site Management, Monitoring visits, Product Reconciliation, Patient Safety, Data Evaluation, TMF Review, Equipment Calibration Review, Subject Recruitment Assessment, Site Communication, assessed product storage conditions and procedures to verify adherence to protocol standards.CRA: Site Start up, Monitoring and Closure, IP Reconciliation, Patient Safety, Data Review, Deviation AE/SA review, Trip Reports, coordinating supplies.Low Back Pain II, III, IV CRA: Site Management, Monitoring visits, Product Reconciliation, Patient Safety, Data Evaluation, TMF Review, Equipment Calibration Review, Subject Recruitment Assessment, Site Communication, assessed product storage conditions and procedures to verify adherence to protocol standards.CRA: Site Start up, Monitoring and Closure, IP Reconciliation, Patient Safety, Data Review, Deviation AE/SA review, Trip Reports, coordinating supplies.Urology Pre-clinicalResearch Associate: Small animal surgery with angioplasty techniques testing vasodilators in a study focusing on arteriosclerotic induced impotency in rabbits. (Boston University Medical School) with sponsor Bristol Myers Squibb |
