Experience

Artivion, Inc.

• United States
• Biotechnology Research
• 500 - 600 Employee

• Senior Project Manager

  • Jul 2014 - Present



Peachtree BioResearch Solutions

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Project Manager

  • Jun 2013 - Jun 2014

  Develop clinical protocols and/or investigational plans, informed consent forms, and case report forms. Liaison between sponsor and investigational sites. Lead team calls and meetings. Develop SOPs, study plans and tools. Identify DSMB members. Develop and finalize DSMB charter. Identify required biocompatibility testing. Prepare site training materials. Collect, query, analyze, and present clinical data. Conduct literature reviews and compose research summaries. Prepare product Instructions for Use and assist with labeling. Generate final clinical study reports. Evaluate and report on adverse events and complaints. Complete necessary product Clinical Evaluation Summaries or other reports necessary to support regulatory submissions. Responsible for site recruitment/selection, investigator meetings, and overall management of clinical studies. Ensure that clinical studies are conducted in accordance with applicable standards and regulations. Oversee project budgets. Show less



Aderans Research Institute

• Clinical Study Specialist

  • May 2010 - Jun 2013

  Responsible for management of protocols as the industry sponsor. Manage vendors to ensure that expectations are met and deliverables are on time while challenging any quality issues Manage study activities from start-up to close-out. Able to take over management of a study at any point in the study cycle. Monitor study timelines to ensure on-time completion of study activities. Negotiate budgets and contracts. Assist with drafting of protocols, electronic case report forms (eCRFs), and clinical study reports. Work closely with data management to set up database. Track study enrollment at sites via electronic systems and direct communication. Track protocol waivers, protocol deviations, and serious adverse events. Conduct study-specific training for sites and CRAs. Conduct co-monitoring visits. Draft visit/trip reports, as appropriate. Review and approve source documents and advertisements. Create and distribute study-specific documentation. Develop study management tools, including clinical monitoring plan. Manage CRAs (allocation, workload, schedule, travel, trip reports). Observe CRAs in the field. Show less



CLINIMETRICS RESEARCH ASSOCIATES

• Project Associate

  • Mar 2008 - Nov 2009

  Responsible for maintaining close working relationship with study sites and pharmaceutical company representatives Coordinate with various sites to ensure completion/collection of all pertinent regulatory documents and submission to study sponsor Responsible for maintaining various documents used to track the progress of a clinical trial Coordinate with sites to ensure completion of initial submission packets for IRB; ensure that initial submissions are in compliance with CFR/ICH, FDA, federal law, state law, and IRB requirements for multiple institutions and those institutions' policies Show less



DISCOVERY ALLIANCE INTERNATIONAL, INC

• Regulatory Affairs Specialist

  • Feb 2007 - Feb 2008

  Responsible for reviewing, evaluating, and assessing all material to be submitted for Institutional Review Board approvalCoordinate with various sites to ensure completion/collection of all pertinent regulatory documents and submission to study sponsorMaintain working relationships with external customers to facilitate submission of clinical investigational material to the appropriate IRB for required approvalCoordinate with sites to ensure completion of initial submission packets for IRB; ensure that initial submissions are in compliance with CFR/ICH, FDA, federal law, state law, and IRB requirements for multiple institutions and those institutions' policies Show less

• Director of Quality Management

  • Dec 2005 - Feb 2007

  Responsible for supervising and training 8 Quality Coordinators at various sites across the USGenerated quarterly audit reports for all sitesResponsible for developing quality improvement projects and tracking progress toward improvement goalsTraining clinical research coordinators to obtain accurate and clean data to avoid errors and minimize data clarification forms

• Quality Coordinator

  • Jun 2005 - Dec 2005

  Internal auditing of all source documents; assurance of quality dataApplication of FDA regulations, CFR, ICH/GCP guidelines, and SOPs Responsible for reviewing variety of office and study documents to ensure high quality service and compliance with relevant regulatory requirements and SOPsEnsured early detection and correction of errors and enabled the use of quality metrics to identify strengths and weaknesses and to track progress toward improvement goals

• Clinical Research Coordinator

  • Aug 2004 - Jun 2005



Saint Joseph's Research Institute

• Clinical Research Coordinator

  • Oct 2003 - Aug 2004



American Cardiovascular Research Institute

• Clinical Research Coordinator

  • Jun 2001 - Oct 2003

  Assurance of efficient and effective clinical trial start-ups, with diligent recruitment and screening of subjects, thorough informed consent process, assurance of subject qualification per protocol inclusion and exclusion criteria, assurance of protocol adherence throughout s study duration, maintenance of quality clinical data management, timely query resolutions, continuous subject monitoring, vital signs, ECGs, lab specimen processing and shipping, study drug accountability, and thorough study close out skills Maintenance of close correspondence and valuable working relationships with various CROs and sponsors during monitoring visits, internal audits, and duration of clinical trials to ensure good data quality, FDA compliance, and protocol adherence Accomplishments include maintaining quality research data and subject care, accurate and consistent data capture attributing to less data clarification forms, and organized coordination of numerous studies concurrently Experience in a broad range of medical specialties Show less



Ophthalmic Surgical

• Assistant

  • Feb 2001 - Jun 2001

  First Assistant in retinal procedures in outpatient surgery centers and clinical office settings. Scheduled all patient surgeries. Obtained consent and educated patients regarding surgical procedures. Performed fluorescein angiograms. Recorded patient history and assessed current symptoms. Triaged patients. Completed JCAHPO (Joint Commission on Allied Health Personnel and Ophthalmology) Ophthalmic Assistance program. First Assistant in retinal procedures in outpatient surgery centers and clinical office settings. Scheduled all patient surgeries. Obtained consent and educated patients regarding surgical procedures. Performed fluorescein angiograms. Recorded patient history and assessed current symptoms. Triaged patients. Completed JCAHPO (Joint Commission on Allied Health Personnel and Ophthalmology) Ophthalmic Assistance program.



EMORY VISION CORRECTION CENTER

• Technician

  • Oct 1999 - Feb 2001

  Responsible for infection control and aseptic technique. Scrubbed and circulated in all refractive surgery procedures (LASIK, RK/AK, LTK, PTK, PRK, Intracorneal Rings). Ordered and maintained inventory of all Operating Room supplies. Updated employee task list and followed up with staff members to ensure accuracy, efficiency, and completeness assigned tasks. Conveyed postoperative instructions to patients. Developed orientation manual for refractive surgery procedures. Responsible for infection control and aseptic technique. Scrubbed and circulated in all refractive surgery procedures (LASIK, RK/AK, LTK, PTK, PRK, Intracorneal Rings). Ordered and maintained inventory of all Operating Room supplies. Updated employee task list and followed up with staff members to ensure accuracy, efficiency, and completeness assigned tasks. Conveyed postoperative instructions to patients. Developed orientation manual for refractive surgery procedures.