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Click here or scroll down to respond to this candidateCandidate's Name
Clinical Research AssociateAtlanta, GAEMAIL AVAILABLEPHONE NUMBER AVAILABLESUMMARYI'm a highly motivated Clinical Research Associate with broad background in clinical trials management of phases I-III trials in various indications including the implementation of study protocols, monitoring of sites and on-site data management and collection. I was a dedicated Clinical Research trial coordinator with more than 6 years of experience.THERAPEUTIC AREASCardiovascular Disease: Pulmonary arterial hypertension (Phase II), Stroke, Hypercholesterolemia -phase I, II.Cardiovascular- Device: Transcatheter aortic valve implantation/repair (TAVI/TAVR), Transcatheter mitral valve repair/replacement, Transcatheter tricuspid valve repair/replacementMetabolic and Endocrinology: Type I diabetes, type II diabetes, Obesity-Phase III,Infectious Disease & Vaccines: Covid-19, Hepatitis C-Phase I, II, III, HIV-1 Infectious- Phase-II, III, Lyme Disease-Phaase IIIOphthalmology: Glaucoma, and Dry Eye- Phase II, IIIGynecology: Endometriosis-Phase IIINeurology: Alzheimer's- Phase IIIWORK EXPERIENCEClinical Research AssociateBioFicher Sciences, Atlanta, GAAug 2022- PresentDevelops strong site relationships and ensures continuity of site relationships through all phases of the trial.Managing the day-to-day coordination and administration of tasks associated with the clinical trial projectAssist with the management of investigational studies from start through study closureProvide continuous data review of source documents, case report forms, data reports as appropriateIndependently prepares conference call and meeting discussion summaries, and memoranda and communications that are timely, technically accurate, grammatically correct, and concise for leadership review with little guidance from the supervisor. Distributes approved correspondence in a timely manner.Assist in review of monitoring reports and tracking of action items. Review source documentation to confirm subject eligibility for clinical trialsDemonstrates mastery of internal and external procedures, policies, and guidelines; reviews and revises existing documents, and drafts new documents as needed. Plays key role in standardization and consistency of support across the project and Serves as an internal and external resource for procedures.Informs the supervisor of complex issues and any related preventive/corrective action and identifies concerns of internal project staff and external clients that may need to be shared with project leadership. Analyzes alternatives and develops solutions to a variety of technical problems of moderate scope and complexity.Provides backup and/or supplemental support for other similar task areas and projects as needed.Participates in mentoring and/or training of other staff at the same (or lower) grade level as needed; contributes to training and mentoring programs as needed; and may also provide general supervision for one or two other staff.Adhere with corporate internal policies and requirements, including submission of timesheets and expense reports in a timely manner.Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols. Member of a site Start-up Team for assigned projects.Review informed consent forms. Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development. Prepare clinical trial agreements and present to site and study sponsor.Monitor sites completion of action items between visits and help prepare for audits and inspections; conduct and write accurate visit reports in accordance with SOPs and GCP (SQV, SIV, IMV, COV)Ensure data entered on the CRFs is timely, accurate and verified. Collaborate with analytical services to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.Develop and maintain trackers, such as visit reports trackers, site trackers, recruitment and enrollment trackers.Participates in mentoring and/or training of other staff at the same (or lower) grade level as needed; contributes to training and mentoring programs as needed; and may also provide general supervision for one or two other staff.Participate in internal TMF reviews, as needed.Review regulatory compliance for study documents and protocols.Overseeing clinical trial activities at investigational sites (will require travel to investigational sites).Performed source document verification, retrieves case report forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites.Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.Ensure that assigned sites are audit and inspection ready.Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.Clinical Research CoordinatorCare Access ResearchMarch 2020-Aug 2022Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing.Worked with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH guidelines.Performed source document verification, retrieves case report forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites.Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issuesResponsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications.Supported project teams in the placement, implementation, communication, site management, recruitment and retention (R&R) issue identification and resolution, and activities requited at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects. Independently off resolution strategies, documenting follow activities/outcomes.Followed the site management / Ownership / Partnership model to monitor multiple Phase I, II & III clinical trial sites, across therapeutic areas.Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.Ensured local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).Clinical Research CoordinatorEmory University Atlanta, GAJan 2018-February 2020Screening, recruiting, enrolling, and evaluating potential patients for protocol eligibility. Presenting trial concepts and details to the patients, participating in the informed consent process, and enrolling patients according to ICH/GCP/FDA guidelines.Managed multiple sites EMR systems and abstract data about all cancer types. .Participated in CAPA identification & implementation.Specialized in Audit Prep & ReviewAssisted PI, SI and RN in recruitment and enrollment of patients. Protection of subjects and subjects rights through IRB relations.Provided clinical trial coordination and project management as specified in IRB-approved pharmaceutical studies.Coordinated patient consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met.Coordinated patient perception in research study. Schedule patients for all pre-study and interim testing, doctor visit, CT and treatment.Maintained patient and study files for source documentation.Provided teaching and training of research protocol to hospital personnel and patients.Preparation of adverse event experience reports. Report SAE to the study sponsor in a timely manner.Performed pharmacokinetic sampling, specimen processing and shipment of blood samples. Insuring all the specimens are packaged according to IATA regulation.Coordinated patient care in compliance with protocol requirements. Interact with Principal Investigator as needed to assure patient receives appropriate medical evaluation and care when needed, alerts Principal Investigator of serious adverse events.Reviewed study patients for changes in conditions, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documented all findings. Serves as a liaison between physicians, nurses, patients, and sponsors.Responsible for accurate and timely data collection, order laboratory investigation, documentation and reporting. Schedule and participate in monitoring and auditing activities.Made use of electronic medical record (EPIC)Assured that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event/SAE reporting.Clinical Research Coordinator (Team Lead)Gyne & Fertility SpecialistsJanuary 2015-Jan 2018Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines.Screening, recruiting, enrolling, and evaluating potential patients for protocol eligibility. Presenting trial concepts and details to the patients, participating in the informed consent process, and enroll patients according to ICH/GCP/FDA guidelines.Performed all tasks routinely and independently. assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project and assessor of peers for sign-off visit purposes.Responsible for coordinating and managing all aspects of clinical trials (Phase II-III) in accordance with GCP guidelines and FDA regulations.Ensured research data is inputted into respective systems in a timely manner and quickly resolves any data queries. Supervised collection of study specimens and ensures proper storage and/or shipping of specimens to studies central laboratory.Responsible for successful management of research participants screening, on study and follow-up assessments according to protocol.Provided leadership and guidance to less experienced coordinator and acts as lead coordinator when needed.Monitored team metrics to ensure study specific goals are met and identifies trends in data reporting errors, data reporting delays and protocol deviations Assist in updating and developing site SOP's.Collaborated with physicians and clinic staff to ensure study procedures are conducted according to protocol.Facilitated training for clinic and research staff on new protocols and protocol amendments as applicable.Educated research subjects and their families on clinical trial participation and their rights and responsibility as a research subject.Coordinated and manages all administrative tasks associated with opening and close out of clinical trials.Responsible for ensuring research subjects screening, on-study and follow-up assessments are complete as per study protocol.Monitored subjects on-study procedures and reports any protocol deviations and serious adverse events in a timely manner.Managed multiple electronic database systems to successfully coordinate clinical trialsPerformed monitoring and site management activities for Phase I-III Oncology clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.Followed-up on study subjects, completion of source documents and case report forms, reporting of serious adverse events, and dispensing/accountability of investigational product.Prepared IRB documents (Protocol, Informed Consent, Narrative, 1572, Contract, Modification Forms, SAE, AE Reporting, IND Safety Reports etc) and submission of project materials to the Office of Human Subjects Protection and Research Review Committee.Maintained subject screening logs and performs quality assurance evaluations as required.Prepared for and participated in Sponsor audits.EDUCATIONMasters degree in clinical research administrationGeorge Washington University2016 2018Bachelors degree in chemistryGeorgia State University2007-2011TECHNOLOGY EXPERIENCE.EDC: Medidata Rave, Oracle Clinical.CTMS: ServiceNow and Seeibo ClinicalTMF: Veeva Vault and Wingspan.IWRS: Suvoda and EndpointPROFESSIONAL SKILLSEffective time management, organizational and interpersonal skills, conflict management, problem solving skills.Able to work highly independently across multiple protocols, sites and therapy areas.High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.Demonstrates commitment to Customer focus.Works with high quality and compliance mind-set.Positive mindset, growth mindset, capable of working independently and being self-driven.Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.Demonstrated ability to mentor/lead.Hands on knowledge of Good Documentation Practices.Proven Skills in Site Management including independent management of site performance and patient recruitment.Demonstrated high level of monitoring skill with independent professional judgment.Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. |
