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Work Background
AbbottClinical Research Data Coordinator II
Jan. 2024United States• Responsible for identifying problems and discussing the issues in the area of clinical data coordination.
• Resolves and/or facilitates resolution of problems including identifying causes of problems to prevent reocurrence of problems.
• Responsible for creating case report forms (CFRs), which includes tracking of all new forms and all modifications made.
• Responsible for maintaining the integrity of information stored in the clinical database through critical review of clinical data forms and the identification of discrepancies. Also responsible for ensuring the integrity of meta data study information, which includes the maintenance of hospital, physicians, and other study
• Ensure there is an adequate supply of stock for Patient data binders, Site Administrative binders and other study documentation.
• Responsible for providing administrative support for clinical studies as requested.
• Responsible for providing support to the clinical evaluation department in preparation for on-site monitoring visits.
AbbottClinical Research Coordinator
Oct. 2023 - Jan. 2024United States• Assist with preparation for monitoring visits, such as internal regulatory file reviews and preparation, as appropriate for the assigned study.
• Maintain records of investigational devices for all assigned regulated studies.
• Facilitate the order and release of clinical IDE device inventory.
• Process invoices as needed and review payment report if applicable.
• Run IRB renewal status report and notify sites of pending IRB renewals.
• Create site regulatory/subject binders for over 100 sites.
• Assist with collection of site activation documents.
• Performs Quality Checks on Study Organizer.
• Filling of approved IRB documentation.
• Organize and track study related documents.
• Collect, file and de-identify adverse event source documents.
• Receive and file study related documents in the appropriate location.
• Assist with preparation for monitoring visits, such as internal regulatory file reviews and preparation, as appropriate for the assigned study.
• Submits sites with contracts and negotiations.
ProPharma GroupPharmacovigilance Specialist
Mar. 2022 - Nov. 2022• Pharmacovigilance case processing: Case follow-up activities: identify information to be collected during follow-up and conduct follow-up calls and prepare written communications to obtain follow-up information. • Write case narratives and review MedWatch/CIOMS/E2B reports.
• Identify events and code with MEDRA
• Completes client notifications as required for case management.
• Aggregate review of Adverse Events/Serious Adverse Events for daily case processing.
ActalentClinical Research Site Activation Coordinator Contract for PPD
Oct. 2021 - Dec. 2021• Developed collaborative relationships with internal clients to conduct high-quality site identification assessments on Phase I, Phase II and Phase III studies.
• Documented and Maintained communication records for multiple studies to the highest quality for accurate daily and weekly reports in various reporting systems.
• Supported the coordination of feasibility activities, such as feasibility surveys and intelligence gathering as required, in accordance with agreed timelines.
• Investigated and proactively resolved issues regarding documentation compliance, documentation tracking, and communication tracking.
• Prepared, reviewed, and coordinated regulatory document submissions (PSP, 1572, ICF, FDF) in alignment with global submission strategy.
• Maintained knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Clinical Research FastrackClinical Research Trainee
Apr. 2021 - Jun. 2021
Clinical Research FastrackClinical Research Trainee
Apr. 2021 - Apr. 2021• ICH GCP E6 R2
• FDA Regulations 21 CFR Parts 11, 50, 54, 56
• Data Management Systems, Electronic Data Capture (EDC) systems like MedRio, Medidata, InForm
• Informed Consent Process
• Clinical Trial Operations from feasibility through close-out (Site and Sponsor/CRO responsibilities and duties)
• GDP following ALCOA-C principles
• Identification and reporting of AEs and SAEs
• Quality Assurance, Monitoring and Query Resolution
• Comprehension and Execution of Clinical Trial Protocols
• Maintaining regulatory binder, housing essential documents including but not limited to 1572, Source documents, DOA, Training Logs, ICF, SAE forms, Financial Disclosures, Subject Enrollment & Identification Logs, Case Report Forms (CRF), Procedure manuals, Standard Operating Procedures (SOP), Site Visit Logs, Correspondences, Trial Master Files (TMF) and other Investigator Site File (ISF) documents
PhotocureSurgical Sales Executive
Oct. 2018 - Nov. 2019Greater Minneapolis-St. Paul AreaSales and customer support specialist for Blue Light Cystoscopy (BLC™) with Cysview®, an optical imaging technology indicated for use in the cystoscopic detection of non-muscle invasive cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.
EuroThreadsNational Sales Director EuroThreads
Mar. 2017 - Apr. 2018Greater Minneapolis-St. Paul AreaA key member of the leadership team, working to identify strategic opportunities for the company to formulate and execute products and solutions sales roadmap. Developed and managed 20 team members of Sales Representatives and providing consistent motivation to exceed sales objectives. Participated in defining new product capabilities and geographical expansion recruitment of new sales members. Coordinated and implemented effective sales training programs. Collaborated with customers to grow and expand their core businesses.
HealthTech Solutions, NOVATHREADS, NeoGraft, Lutronic, BTL Industry, ViroraTerritory Manager
Oct. 2015 - Apr. 2017Responsible for capital sales of four aesthetic companies and rental sales to clinics, surgery centers and hospitals
o Developed relations ships with Plastic Surgery, Urology, ENT and Ophthalmology
o Negotiated contracts with manufactures o Capital sales growth of 650,000 in sales in just 7 months
o Developed 7 new rental locations
o Maintained relationships with current rental locations and increased rental business
SanofiSenior Sales
Jun. 2013 - Oct. 2015MinnesotaResponsible for calling on Endocrinology, Hospital education staff and Hospital Pharmacies. o Developed two key option leaders as speakers for two new drugs
o Two new product launches
Life Scan IncTerritory Business Manger II
Jan. 2005 - Sep. 2011Responsible for retail and direct sales of blood glucose monitoring equipment in central MN. Customer base includes Endocrinology, Internal Medicine and Family Practice departments, Certified Diabetes Educators, other diabetes self-care personnel to garner recommendations of diabetes-related self-monitoring products. In addition, responsible for contact and sales with hospital point-of-care directors, hospital/retail pharmacies, drug wholesalers, med/surgical distributors, government accounts, managed-care organizations, and integrated health systems.
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