Candidate Information Title Business Co-Owner, Clinical Research Associate Target Location US-TN-Greeneville Email Available with paid plan Phone Available with paid plan

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Amy LeeGreeneville, TNPHONE NUMBER AVAILABLE (Telephone)PHONE NUMBER AVAILABLE (Fax)EMAIL AVAILABLE (E-mail)Personal ProfileI demonstrate a strong sense of responsibility and team spirit. Being dedicated to organization of professional and personal duties, I aspire to assist other teammates in meeting their goals, as well. I ensure timelines are met with keeping true to guidelines and budgetary requirements. Developing and monitoring sales/marketing strategies to ensure company revenue remains secure, is a passion. I prioritize obtaining new business opportunities in company assigned regions, for proper growth and expansion. I also conduct presentations, including educational meetings, to instruct on effective sales methods/strategies.EDUCATION2004  2008 East Tennessee State University Undergraduate/B.S.Major: Allied Health - Radiology Technology2002 - 2004 Northeast State Technical Community CollegeUndergraduate/A.S.Major: Aerospace - University ParallelEXPERIENCE2018  Present McIntosh & Lee Insurance Agency Business Manager/Owner Insurance Agent Advertising Primary contact for Agents, Clients and Vendors Create working environment that is harmonious for all Reiterate business vision and goals effectively to Agents for safeguarding understanding and compliance Motivate Agents to exceed expectations of business and self Integrate organizational procedures into business office policies Properly review and monitor business projects to ensure prompt completion while remaining within budget limits Create business advertisements for radio and newspaper Identify new obtainable opportunities in existing area and surrounding counties Establish new marketing strategies to secure new business and win over clients and third-party vendors Guarantee retention of existing clients Co-responsible for Agent and Administrative Assistant payroll Ensure business resources are appropriately allocated towards immeasurable result generation Procurement of office supplies2017  2019 Syneos Health US Inc. Clinical Trial Site Manager Clinical Study/Clinical Site Management  Traveled overnight 60-80% Confirmed regulatory, ICH-GCP, SOP and protocol compliance Performed site qualification, site initiation, site monitoring, site motivational and site close-out visits(on-site and remotely) Used judgement and experience to evaluate overall performance of site and site staff to provide recommendations regarding site specific actions Technically communicated to escalate serious issues to project team and developed action plans Effectively conducted source document review of site source documents with medical records and source data verified appropriately Utilized available hardware and software programs to support the conduct of the clinical study data review and site/study compliance Verified the Investigational Product (IP) had been stored, dispensed, and administered to clinical subjects according to the study specific protocol Applied query resolution techniques remotely and on-site within mandated timelines Routinely reviewed the Investigator Site File (ISF) for accuracy and completeness Reconciled contents of the ISF (essential documents) with the Trial Master File (TMF) Documented activities via confirmation letters, follow-up letters, trip reports, communication logs and additionally required documents as per SOPs and Clinical Monitoring Plan/Site Management Plan Supported subject recruitment, retention, and awareness strategies2015 - 2017 TFS Trial Form Support Inc. Senior Clinical Research AssociateLead Clinical Research AssociateInterim Project ManagerLead Clinical Research Associate and Interim Project Manager (9/2015  6/2017)Senior Clinical Research Associate (2/2015  9/2015) Reviewed and approved project scopes, budgets and timelines for clinical activities Ensured meeting project objectives/deliverables are completed within dedicated timelines Arranged meetings with Sponsors, Vendors, CRA staff and Sites Prepared/trained clinical teams initial and updates Updated Monitoring Plan, Communication Plan, Protocol, SOPs, Wis and following of applicable guidelines Reviewed trip reports and review action items for appropriate/timely closure Verified all scheduling and completion of IMVs according to Sponsor/Client timeline and instructions Confirmed completion of study metrics Conducted assessment visits on clinical team Approved expense reports and timesheets Remained up-to-date on the TMF to always ensure audit readiness until proper return to the Sponsor at clinical trial end of study Managed all site-level activities when Senior Clinical Research Associate Clinical Study/Clinical Site Management  Overnight travel 60-80%2008 - 2015 Chiltern International Inc. Senior Clinical Research AssociateClinical Research Associate IIClinical Research Associate ITraining Clinical Research Associate Conducted site qualification, site initiation, site monitoring, site motivational and site close-out visits at assigned clinical trial sites Forwarded proper study materials to appropriate study team and clinical site staff Developed source documents for clinical study sites Secured the integrity of all clinical monitoring data Scheduled all study visits according to Sponsor related travel guidelines and budgeting Completed study reports and follow-up letters for each monitoring visit Reviewed project progress and initiate actions to achieve target objectives Interacted with internal work groups to evaluate needs, resources and timelines Acted as a point of contact for clinical trial supplies (vendors) as assigned Conducted feasibility tasks as assigned Assisted in the training, mentoring and development of new employeesSKILLS/CERTIFICATIONS/PERSONAL AFFLIATIONS Business Management Site and Staff Management Relationship Building Flexible Self-driven Strong Computer Skills Technical Communications Advertising & Promotion Multiple Computer Programso Accident and Health Insurance Tennessee License 2019o Property and Casualty Insurance Tennessee License 2022CLINICAL EXPERIENCEo Infectious Disease/Vaccineo Respiratory/Asthma & COPDo Endocrinology/Diabetes Type IIo Mens Health/Peyronies Diseaseo Cardiology/Heart Failureo Gastroenterology/OIC & CICo Ophthalmology/Wet & Dry Macular Degenerationo Auto-Immune/Psoriatic Arthritiso Dermatology/Atopic Dermatitis & Chronic Plaque Psoriasis