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Click here or scroll down to respond to this candidateSmyrna, Delaware, USA PHONE NUMBER AVAILABLE EMAIL AVAILABLECandidate's Name
PROFILE Analytical Clinical Research Associate with talents in project development and screening to document and report clinical study progress. Almost 10 years of experience in risk assessment, project management, data management, and regulatory documentation. Therapeutic experience in Phase I - IV Oncology, Respiratory, Cardiovascular, Infectious, Dermatology, Gastro Intestinal and Rare Disease clinical trials. Results-oriented with excellent oral / written communication, organizational, and problem-solving skills. Coordinates and facilitates research activities and submits documents for regulatory approval. Serves as point-of-contact for clinical research professionals and coordinates lab samples to compile detailed data. Well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking, standard operating procedures and good clinical practice. Supports participant recruitment and management to meet research objectives.HEALTHCARE &CLINICALRESEARCH SKILLSClinical Research Management (Study Start-Up through Closeout), EU & US Data Privacy and Protections, Site Monitoring and Oversight, ICH-GCP Compliance, Site Initiation Visits, Investigator Meetings, Patient Safety, Database Locks, and Data Management.TECHNOLOGYSKILLSMediData Rave, EPIC, Oracle Remote Data Capture (OC RDC/TAO), Inform EDC, Interactive Web Response System(IWRS/IVRS), Veeva Vault, DrugDev Spark, Microsoft SharePoint and TransCelerate Shared Investigator Platform (SIP) EDUCATION Temple University, Philadelphia, PABachelor of Science in BiochemistryTHERAPEUTICAREASRespiratory, Cardiovascular, Infectious Diseases, Oncology, Central Nervous System, Dermatology, Gastrointestinal, Rare DiseasesWORK HISTORY SENIOR CLINICAL RESEARCH ASSOCIATE August 2015 to Present ICON Clinical Research Successfully identify, select, initiate, monitor and close out investigational sites for multiple clinical studies, ensuring adherence to study protocols, SOPs/WPs, and applicable regulations. Assess sites and inform clients of sites who meet all criteria but have underlying factors which would prevent adequate study participation such as time constraints, workload, etc. Leads and collaborates with site staff during initiation visits on establishing site recruitment plan. Lead and conduct thorough site monitoring visits to verify data accuracy, patient safety, and protocol compliance while maintaining meticulous documentation and providing timely reporting. Generate detailed monitoring visit reports and telephone contact reports in accordance with monitoring plan including action items Demonstrate expertise in ICH-GCP principles, consistently delivering high-quality monitoring services that meet or exceed client expectations by monitoring site ICH-GCP compliance, patient safety, and completeness and quality of the on-site files. Meet with sites weekly to ensure all procedures are being followed and any mistakes are not perpetuated. Organize meetings among sites for exceptional sites to train less experienced sites in good clinical practices and successes such as recruitment strategies. Participate in Investigator and other external or internal meetings as required and communicate with Clinical Monitoring Associates regarding site issues and actions prior to planned visits. Ascertain and recommend appropriate follow-up response to issues at clinical sites and conducts on-site study-specific training, site facilities inspection and collection of regulatory documents. Identify, document and resolve site regulatory issues, questions, and concerns discovered during visits. Implement CAPAs to completion. Collaborate with cross-functional teams and actively participate in various aspects of study management, including study start-up activities, regulatory submissions, and study budget management. Reviews site-level data in clinical systems, evaluates data quality issues, and implements follow- up response Assist in developing and improving company systems and procedures, contributing to enhancing operational efficiency and regulatory compliance.Page 2 Candidate's Name
Provide coaching and mentoring to less experienced colleagues, enhancing their monitoring competence and fostering a culture of continuous learning. Play a pivotal role in streamlining processes and adding value to business operations, consistently seeking opportunities for process improvement. Independently and proactively coordinate study setup and monitoring activities, ensuring timely and accurate execution. Direct sites to develop SOPs for recruitment, informed consent, protocol compliance patient retention, etc Recognize at risk subjects in study populations and ensure all options and resources are provided to them Identify inconsistencies in protocol, study monitoring manual and other study documents and provide modificationsCLINICAL RESEARCH ASSOCIATE February 2014 to July 2015 Parexel International Established and nurtured strong relationships with investigators and site staff, serving as PAREXEL's primary contact for assigned clinical sites. Demonstrated judgment and expertise to assess and maintain the overall integrity of study implementation and ensure strict adherence to study protocols at clinical sites. Participated in Investigator Meetings and other external or internal meetings as required, facilitating effective communication and collaboration. Organized on-site visits and managed logistical arrangements to ensure smooth and productive monitoring activities. Conducted on-site visits strictly following the monitoring plan, using sound judgment and knowledge to resolve site issues, questions, and concerns independently. Identified and recommended appropriate follow-up responses to issues at clinical sites, including deficiencies in documentation, communication, and the need for additional training. Conducted remote visits as necessary or requested to maintain oversight and compliance. Delivered on-site study-specific training to ensure site staff's understanding and protocol adherence. Performed comprehensive site facilities inspections to ensure suitability for study purposes. Monitored patient safety on-site, promptly addressed protocol violations, and provided immediate reports and recommendations to the Functional Lead. Evaluated the overall compliance and performance of sites and site staff, offering recommendations for site-specific actions based on judgment and experience. Ensured and maintained ICH-GCP compliance throughout the study duration. Monitored and maintained the completeness and quality of on-site files to meet regulatory and internal standards. Responsively addressed site issues alerted to and identified by the Clinical Monitoring Associate(CMA), including non-responsive sites, Protocol Deviations concerns, quality issues, and other matters requiring face-to-face interactionSmyrna, Delaware, USA PHONE NUMBER AVAILABLE EMAIL AVAILABLE Candidate's Name
HISTORY OF ASSIGNED STUDIESMay 2021 Current Lyme BorreliosisSafety and immunogenicity study of vla15, a multivalent recombinant ospa based vaccine candidate against lyme borreliosis: a randomized, controlled, observer-blind phase 2 study in a Page 3 Candidate's Name
healthy pediatric and adult study population RSVPhase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the safety, immunogenicity, and efficacy of Pfizer's RSVpreF in the prevention of LRTI-RSV in adults 60 years of age and older during the first RSV season and the long-term immunogenicity and efficacy of RSVperF across multiple RSV seasons. COVID VaccineA Phase 2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a SARS-CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older Rare Disease - AchondroplasiaA Phase 2 study to investigate the safety, tolerability, pharmacokinetics (PK), and efficacy of Recifercept in children with achondroplasiaJuly 2019 May 2021 Thermal BurnsA multicenter, multinational, randomized, controlled, open-label study performed in children with thermal burns to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment Pneumococcal Conjugate VaccineA phase 2, randomized, open-label trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine given with, or separately from, 13-valent pneumococcal conjugate vaccine in healthy infants Type II Diabetes MellitusA Phase 2A, randomized, double-blind, placebo-controlled, 3-arm, parallel-group study to evaluate safety, tolerability, and pharmacodynamics of PF-06835919 administered daily for 16 weeks in adults with non- alcoholic fatty liver disease and Type 2 Diabetes Mellitus on metformin September 2015 to July 2019 Clostridium Difficile VaccineA phase 3, placebo-controlled, randomized, observer-blinded study to evaluate the efficacy, safety, and tolerability of a Clostridium difficile vaccine in adults 50 years of age and older Clostridium Difficile VaccineA phase 3, placebo-controlled, randomized, observer-blinded study to evaluate the lot consistency, safety, tolerability, and immunogenicity of a clostridium difficile vaccine in healthy adults 65 to 85 years of age Atopic DermatitisA phase 3 randomized, double-blind, multicenter, long-term extension study investigating the efficacy and safety of Pf-04965842, with or without topical medications, administered to subjects aged 12 years and older with moderate to severe Atopic dermatitis Atopic DermatitisA phase 3 randomized withdrawal, double-blind, placebo-controlled, multicenter study investigating the efficacy and safety of pf-04965842 in subjects aged 12 years and over, with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects Atopic DermatitisA phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of Pf-04965842 monotherapy in subjects aged 12 years and older with moderate to severe atopic dermatitisPage 4 Candidate's Name
DMID Research ProtocolA multi-study, multinational, multicenter program supporting the Division of Microbiology and Infectious Diseases across their Clinical Research Operations Portfolio: DMID-CROMS Ulcerative ColitisA phase 2a, multicenter, single-arm, open-label, two-stage, study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of XXXX in subjects with moderate to severe ulcerative colitis. Pediatric Bi-PolarA phase 3, multicenter, four-week, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety trial of flexible doses of oral XXXX in children and adolescents with bipolar I disorder (current or most recent episode manic) HypercholesterolemiaA phase 3 double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of XXXX in subjects with primary hyperlipidemia or mixed dyslipidemia at risk of cardiovascular events |
