Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Sr. Clinical Documentation Specialist
Duties: We are currently seeking a Senior Clinical Documentation Specialist who will play a crucial part on the clinical trial team and is considered a key contact before, during and after the clinical trial concludes. The position itself shall assist in the coordination and management of documentation associated with conducting clinical studies. This position shall assist CRAs and other functional areas with the management of essential documents, and may also serve as a resource during internal and/or external audits as well as regulatory inspections. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
The successful candidate shall work on assignments requiring considerable judgment and initiative. Understand implications of work and makes recommendations for solutions and determine methods and procedures on new assignments.
This position provides support to clinical research including, but not limited to, maintenance of essential documentation, clinical trial tracking and information retrieval. Manages access and organization of the controlled clinical documentation storage on-site, including ensuring the defined file structure is maintained. Manages the exchange of essential documents with external service providers. Maintains quality check schedule and performs periodic inventories of study/project TMF to ensure completeness. Assists with off-site archiving activities (including budget, cataloguing process, and document retrieval). Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines, work instructions, and appropriate industry and Good Clinical Practices standards.
Skills: Typically 6 years industry experience working in the Pharmaceutical, Biotechnology or other related industry is required. Equivalent experience may be accepted. Strong attention to detail. Good communication skills both oral and written are a must. Good computer skills are required, (working knowledge of MS Word, Excel, and PowerPoint is required).
Excellent organizational skills are required.
Education: Requires a minimum of a High School diploma. An Associate degree is a plus.
Skills and Experience:
EXCELLENT ORGANIZATIONAL SKILLS
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Duration: 3 months+
Locations: San Francisco, CA
ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776