- Process prescriptions including verifying appropriateness, entering, submitting insurance claims and filling. - Counsel patients regarding prescription medications, self care products and general health concerns under the guidance of a registered pharmacist.- Provide customer service to both patients and health care providers.

• completes AE report receipt.• Completes first line review and case evaluation, global notifications, data entry per DEGS for Safety Data Base and other data bases as needed.• Assures accurate and complete data entry compared with source documents in effective quality check practices.• Prepares and routes disposition form and reviews packets per established timelines, obtaining appropriate Medical, Regulatory, and/or Clinical sign-off as needed.• Produces final MDR Med Watch or CIOMS 1 forms and routes to appropriate Regulatory or designated agency for submission within required timelines.• Produces DD questions and develops standard DD questions for unique “signal” reports in collaboration with Safety Monitor.• Maintains case files per GCP and “audit ready” state.• Conducts case closure activities routinely.• Drafts responses to Medical inquires, i.e. with Medical Director or Supervisor, determine the scope of the IR query, develop query for IT support staff to run, complete a preliminary review and aggregate summary of data for management to review and approve.• Compile, review with Manager, and forward routine monthly trending summary to QA.• Assist in producing tables and listings for various Regulatory reports (Annual Report, PSURs, Five-Year Renewal for EU), i.e. QC Line Listing, update data base if needed, assure data base is complete and accurate, preliminary tally of reported cases, and draft report segments as needed.

- Facilitate the development and execution of contracts and budgets in support of all therapeutic area clinical trials, with specialty in oncology and hematology.- Primary duties include tracking database administration; creation, coordination and distribution of Clinical Study Agreements, Investigator Budgets and Amendments, document review and editing; assistance with information retrieval in support of contract and budget development; and contracts administration support.

- Coordinate and perform in-house monitoring activities as related to the conduct of pharmaceutical, biotechnology and medical device clinical trials. - Provide technical services for the collection, review, maintenance and tracking of regulatory documents from clinical sites. - Develop an understanding of clinical trials research through exposure to research protocols, a variety of therapeutic areas, the phase I through IV drug development process, Company Standard Operating Procedures (SOPs), and Food and Drug Administration (FDA) guidelines as related to Good Clinical Practices (GCPs).