Clinical Trial AssistantPerrigo Company - Bronx, NY
This position is responsible for supporting clinical affairs programs by assisting in daily administrative and clinical trial support activities including but not limited to Investigational product inventory reconciliation, generating internal/external documents/trackers, compiling data, maintaining project databases, records, contracts and other research records and auditing of Trial Master files, and other duties as assigned. This position shall further include some clerical and administrative duties including but not limited to the processing of invoices for payment, preparation of project and training materials, scanning and coordination of disaster recovery assignments, meeting coordination and meeting minutes, and purchase orders.
Create and maintain comprehensive record systems for hard copy and electronic clinical documents. Accurately classify and store project documents to ensure easy retrieval. Coordinate, upload, and maintain archived clinical files which may be stored off-site.
Maintain all contracts and invoices for the department’s work on clinical trials. Route new contracts for appropriate review and signatures. May review invoices to assign to appropriate projects or contracts prior to review by the manager. Maintain Purchase order and invoice payment processing duties.
Maintain clinical supply inventory and records. Coordinate shipments to Investigator sites and ensure all distribution and maintenance records are updated accurately and promptly. Order and maintain samples of reference products. Ensuring the security of samples and supplies. Maintain Retain Samples according to company policy and handling of destruction activities.
Prepare reports and analyses for the manager. This may include literature searches, project status reports, contract or billing summaries and other information assistance. Maintain clinical study databases/trackers. Review raw data and identify any issues or gaps and work with the manager and service providers to resolve. Prepare reports and summaries that provide metrics to support process improvement.
Provide administrative support to the Clinical Affairs department, including clerical support, coordination of meetings, travel and luncheons, development of meeting and training materials, purchasing, shipping and internal and/or external communications. This may also include providing updates to the department or project websites, taking meeting minutes, expense reporting and other support services as assigned.
Good organizational and effective communication skills and attention to detail are necessary. Proficient computer skills are required, including experience using the full suite of Microsoft Office software. Must be well organized and able to follow directions well and follow up on assignments independently. Good communication skills are essential. Some bookkeeping background is necessary and shorthand is preferred (although not required). Must have a Bachelor’s degree or equivalent in a physical or life science preferred combined with several years of office experience and one to two years clinical research and/or Quality Assurance experience. Familiarity with clinical research processes, GCP regulations, scientific terminology and maintenance of clinical supply records is strongly preferred.
11 days 5 hours ago
applyClinical Trial Assistant Perrigo Company - Bronx, NY, United States
Headquartered in Ireland, Perrigo Company plc is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements, active pharmaceutical ingredients (API), and medical diagnostic products and receives royalties from Multiple Sclerosis drug Tysabri®.
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