The incumbent will either assist or act as the Local Trial Leader at a level commensurate with experience in the implementation of Phase II-IV clinical studies in the US Infectious Disease and Transplant Immunology area. Key responsibilities will include interacting with a regionally based field monitoring group and managing clinical investigative sites in the day-to-day activities of clinical trials, preparation of required study documents (including regulatory documents), and assuring that data is collected according to client Standard Operating Procedures. The incumbent will also interact with other line units in support of clinical trials and ensure that project timelines are met by closely monitoring study activities and resources. Additionally, the CRS may also assist in the preparation of Clinical Trial Protocols, Clinical Trial Study Reports, publications/manuscripts and may also serve on the clinical trial team. Some travel may be required but is typically less than 10%.
Skills: **PREVIOUS CLIENT EXPERIENCE A BIG PLUS***
Effective oral and written communication skills are a must. The demonstrated ability to independently write Clinical Trial Protocols and Clinical Trial Reports is required for a senior level position. The ability to work both independently and collaboratively on Project teams and to recognize safety and efficacy data trends is essential. Knowledge and experience of clinical trial design, analysis, and reporting (for senior positions) is also necessary. The Sr. CRS should be familiar with all aspects of the drug development process and have knowledge of the medical, scientific and clinical research techniques of the assigned area. Working knowledge of GCP and local regulatory requirements is desired.
Education: BSN or RN, BA or BS in a scientific discipline, or a pharmacy degree (or equivalent), and at least 2 years of clinical research experience in a pharmaceutical environment. The position will be filled at a level commensurate with experience, however, the requirements include a minimum of a minimum of five years relevant experience in a clinical research/drug development environment is required for a Sr. CRS position. A background in pharmaceutical industry research in the therapeutic area is preferred, but is not required.