Robin Heck Email & Phone Number

Wilmington, Nc, Us

Wilmington, North Carolina, United States

On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD. Together, Thermo Fisher and PPD share the pursuit of a common goal: to enable customers to make the world healthier by accelerating the development of new medicines.

Wilmington, North Carolina, United States

Worked on more than 10 phase I-III clinical trials in adult, pediatric, elderly, and adolescent populations. Performed initial submissions, substantial amendments, and notifications. Prepared, reviewed and coordinated local regulatory submissions (MoH, EC and additional special national local applications as applicable) in alignment with the global submission strategy. Coordinated with internal functional departments, to ensure various site start-up activities were aligned with submission activities and mutually agreed upon timelines. Ensured the submission process for sites and studies were aligned to the critical path for site activation. Had contact with investigators for submission related activities and served as a key contact at country level for either Ethical or Regulatory submission related activities. Prepared Regulatory Compliance Review packages, including working with the SIA CRA as applicable. Developed country and site-specific Patient Information Sheet/Informed Consent form documents. Captain: Acted as primary point of contact for the Start-up Country Project Team in Country/Countries and coordinated Start-up Country Team activities and updates to the team. Provided project specific local submission strategy and maintained a clear understanding of the country status details. Responsible for identifying, escalating & mitigating risks, driving efficiencies and improving team ability to hit site activation projections. Worked with the STM and the other project stakeholders, streamlined communication in and out of the Clinical Operations Country Team. Drove the complete country critical path to site activation and facilitates handover to Clinical Management Team. Acted as Captain for 1 Musculoskeletal study and 1 Dermatology study.

Wilmington, North Carolina, United States

Worked on over 5 phase II-III and observational clinical trials in the adult and elderly population. Prepared, reviewed and coordinated local EC submissions and preparation of local MoH submissions as applicable, in alignment with the global submission strategy. Coordinated with internal functional departments to ensure various site start-up activities were aligned with submission activities and mutually agreed upon timelines. Prepared site-specific Patient Information Sheet/Informed Consent form documents and acted as a key contact at country level for either Ethical or Regulatory submission related activities. Responsible for preparing Regulatory Compliance Review packages, including working with the start-up CRA as applicable.

Wilmington, North Carolina, United States

Coordinated, supervised, and performed administrative functions on trials including review of regulatory documents, file review, and implementing project plans to ensure achievement of goals within study timelines. Managed and oversaw administrative project team to ensure proper conduct of administrative activities through all stages of clinical studies (start-up, maintenance, and close-out). Trained, mentored, and provided secondary review for new Project Assistants, assisted departmental leadership in determining training needs, and provided input for performance appraisals. Interviewed and evaluated candidates and conferred with Senior Project Assistants and Managers regarding hiring decisions.

Wilmington, North Carolina, United States

Responsible for oversight and maintenance of data in client specific systems. Performed quality control of Client-PPD data interface and coordinated study team in resolving data quality errors as needed. Managed meeting calendars for multiple studies, created and maintained an electronic study repository for working documents and study-specific distribution lists within the client system.

Wilmington, North Carolina, United States

Coordinated and performed administrative functions on trials including review of regulatory documents, file review, and implementing project plans to ensure achievement of goals within study timelines. Maintained a working knowledge of GCPs, PPD Global SOPs, applicable client SOPs, and protocol-related specifics to ensure site regulatory compliance and audit readiness. Trained and mentored Project Assistants, assisted departmental leadership in determining training needs, and provided input for performance appraisals.

Wilmington, North Carolina, United States

Coordinated and performed administrative functions on trials including review of regulatory documents, reconciling project reports, and documenting meeting minutes.Communicated with monitors and investigative sites to resolve regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner.

Wilmington, North Carolina, United States

Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and Client Company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client. Performed PPD investigator file reviews and logged outstanding issues in project related tracking tools. Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner. Developed and maintained assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines.

Leland, Nc

Interviewed, hired, trained, and managed all receptionists and completed performance reviews and employee improvement plans.Ordered and maintained pharmacy inventory to minimize hospital costs and ensure needed medications were in stock in adequate amounts. Implemented a new inventory management and control protocol that reduced inventory cost from 9% to 2% of overall hospital expenses during a 12-month period.Coordinated a cross-departmental plan to ensure compliance with over 100 standards of care and was instrumental in assuring that the hospital achieved accreditation by the American Animal Hospital Association.

Leland, Nc

Organized and trained client service representatives to provide exceptional client care in a fast-paced, hospital environment. Developed a new hire training protocol and detailed training manual for greater competency and efficacy.

Leland, Nc

Optimized client satisfaction and provider time when scheduling appointments. Effectively communicated messages between providers and clients and documented medical instructions and relevant communications in the patient medical record.

Bachelor Of Science - Bs, Clinical Research

Bachelor Of Arts - Ba, Middle Grades Education, Science/Social Studies Concentration