Karla Quick Email & Phone Number

Raleigh, Nc, Us

Waltham, Ma

• Primary liaison and intermediary between the Histogenics Marketing team and the Histogenics Clinical team in support of clinical marketing and recruitment/retention activities for the Phase 3 NeoCart clinical study• Work with the Director of Clinical Marketing to devise strategic marketing plan and effectively implement cooperatively with Clinical Research Specialists• Support close collaboration with Management for the coordination, planning, implementation and tracking of patient recruitment and future patient retention support strategies • Marketing tool creation and education at site level and with Clinical Research Specialists• Responsible for assessing and identifying additional recruitment needs• Responsible for working and coordinating with the Clinical and Marketing teams to track marketing activities at local and geographical levels across all sites (including utilization of current and new marketing tools and materials), assess recruiting effectiveness based on the roll-out of new and existing marketing tools and materials, as well as local marketing campaigns, and assist with the design, production, implementation and upkeep of metrics and reporting (i.e. marketing / SEO dashboard, clinical event calendar) in support of trial recruiting activities • Close interaction with the vendors and consultants who currently support recruitment efforts • Event planning and execution

Southeast

• Serve as a liaison and resource for investigational sites in the operating room and for training purposes• In collaboration with the Clinical Affairs and the Research & Development functions, develop product training strategies, materials and tools to meet objectives. • Coordinate and manage the Surgeon Investigator Training • Establish key strategic partnerships, surgeon faculty to enhance peer-to-peer focus groups.• Understand and ensure compliance with regulatory policies and procedures relating to training and education programs• Represent the corporation in public forums (e.g., oral presentations, poster presentations, society meetings, etc.) in an effort to raise awareness about the NeoCart Clinical Trial• Coordinate arrangements/logistics for education programs to include product, facilities, materials, etc.• Ability to establish solid relationships with key opinion leaders, hospital research personnel to enhance clinical trial objectives.• Develop & nurture key opinion leader relationships on local, regional and national levels.• Pursue highest standards of support and service that exceeded customer expectations.

Home Based

•Assist Clinical Management with the development, approval, distribution of study related documents including Case Report Forms (CRFs), study protocols, study manuals, and other study tools to investigational sites•Aid in the preparation of IRB submissions•Monitor ongoing compliance to study protocols and site adherence to regulatory guidelines•Maintain SOPs for the department as assigned by management•Provide technical and scientific guidance to investigators and study site personnel to ensure consistency in all clinical trial-related materials•Conduct site visits and work with clinical sites to resolve any site related issues quickly and effectively•Ensure that sites’ documentation meets FDA/GCP/ICH requirements •Manage site distribution, collection and tracking of regulatory documentation to ensure compliance •Tracked and reported progress of studies including subject enrollment/screening, data collection, adverse event documentation, and FAQ’s•Perform query writing and resolution process•Ensure adherence to study timeline and liaise between Sponsor and Site for contract and budget negotiations

Boston

• Coordinate and implement subject recruitment, interviews, enrollment, study monitoring and follow-up, data collection, and study conduct• Build rapport with subjects at clinical sites including ER, Urgent Care, In-patient, Primary Care and Public Health clinic• Prepare, coordinate, and assist in study protocols and IRB applications including continuing review and amendment preparation• Work with Principal Investigator on presentations preparation• Conduct extensive literature reviews• Submit Questionnaire Development System (QDS) data modules to CDC • Assisted in hiring staff within the Section of Infectious Diseases-screen applicants; perform phone and in-person interviews, reference checks; and facilitate relationship with new hire and HR

Provide support for a large diet recall research study interviewing patients in a sensitive, professional manner and overseeing the scheduling of all patient interviews

Support workforce survey, development, data collection and analysis as well as extensive literature reviews of existing surveys on the dental, nursing, and physician assistant workforce to better understand issues related to recruitment and retention of the workforce and more specifically primary care and health access.

Offer administrative support for the Director of Principal & Major Gifts, performing budget reconciliations, assisting in formulating the FY2009 operating plan, interacting with major donors, and overseeing two development assistants.

Provide administrative support for two Associate Directors in the Major Gifts Unit, including managing correspondence, scheduling meetings, mail, and appointments for supervisors. Performed gift processing, handling terms of agreement and acknowledgements, and tracking pledge status and gift payments as necessary for donor inquiries and clarification for staff.

Master, Public Health

Masters in Public Health

Ba, Spanish And Italian

Education record

Master Of Arts, International Relations

Merit Thesis: The Making of Spanish Femininity: From Franco to Modern Spain