Durham, North Carolina, USA
166 days ago
Senior Clinical Research AssociateAssociate Clinical Trial Manager
The qualified applicant will be responsible for monitoring study sites, co-monitoring with the CRO Clinical Research Associates and working with the Viamet Clinical Trial Managers on in-house or outsourced studies to ensure that all operational deliverables e.g., timeline, quality, productivity are met. Candidates must be willing to come in-house Durham Office when not traveling. Duties and Responsibilities Establish efficienteffective working relationships with internal team members, sites and vendors Prioritize effectively and respond appropriately to urgent requests from the team or other internal staff Perform or attend as a co-monitor site selection, initiation, interim monitoring or close-out visits in various therapeutic areas Evaluate the quality and integrity of the study site andor vendor CRA as related to the proper conduct of the protocol and adherence to applicable regulations Work with the team to manage start-up activities, including site contract and budget negotiations and collectionreview of all essential documents Work with the team to developreview study plans and tools i.e., monitoring Plan, Study Procedures Manual, tracking logs, Informed Consents, eCRF completion guidelines, etc. Maintain and track study metrics to ensure vendors are meeting agreed targets Other duties as assigned by senior management e.g. Assist with Investigator Meetings Required Skills Candidate should be able to Lead a virtual team across locations and cultures Prioritize project tasks and direct the team accordingly Negotiate and influence with diplomacy in order to achieve effective results Proactively identify and solve problems by using a logical, systemic approach Ability to take initiative and work independently Excellent interpersonal, oral and written communication skills Ability to be flexible and adapt to change in a fast paced, small company environment Strong knowledge of pharmaceutical industry regulations, including FDA regulations, GCP and ICH guidelines Knowledge and experience in specify disease preferable Proficient with the Microsoft Office suite of products and strong computer skills
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