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Clinical Research Scientist

Company name
Renal Advantage Inc.

Waltham, MA

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PURPOSE AND SCOPE:The Clinical Research Scientist will support the conduct of both pharmaceutical and device trials. This position is responsible for clinical as well as operational activities and for taking initiative to respond, resolve, and follow up regarding clinical trial issues with all trial investigators, as well as external and internal partners in an effective manner.PRINCIPAL DUTIES AND RESPONSIBILITIES:Developing professional expertise; applies company policies and procedures to resolve a variety of issues.Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors.  Exercises judgment within defined procedures and practices to determine appropriate action.Support all operational aspects of clinical trial activities (Phase I through IV) and clinical program activities as assigned. Responsibilities include:Contribute to the development of clinical trial protocols based on the study design and related documents.Development of study tools including guidelines and training materials for study sites and investigators.Communication with CROs as well as external vendors, clinical and analytical laboratories.Implementation of issue resolution plans.Contact with study coordinators at trial sites.Tracking of local study approvals (IRB reviews) and patient enrollment.Ensuring study drug supply; contribution to the clinical study reports; etc.Contribute to development of SOPs and department policies and procedures.Must be able to work on multiple studies simultaneouslyContribute to the development of study budget and timelines.Ensure that all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Support clinical outsourcing specifications and day to day operational activities with Contract Research Organization(s) (CROs) and/or other 3rd parties.Manage interactions with other relevant functions including Regulatory Affairs, Drug Supply Management, MSL team, Clinical monitoring (CRA team), Contract and Legal department, as well as external partners.Update regularly all trial information and track accuracy of informationContribute to the ongoing scientific review of the clinical trial data during the course of the trialSupport trial data analysis and reporting (e.g., AEs)Support and Coordinate Investigator initiated studies (IIRS):Responsible for reviewing various proposals from investigators.Schedule and coordinate the Review Committee meetings.Keep track of study proposals and related documents.Build productive working relationships.May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.May refer to senior level staff for assistance with higher level problems that may arise. Escalates issues to supervisor/manager for resolution, as deemed necessary.Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.Assist with various projects as assigned by direct supervisorOther duties as assignedAdditional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.PHYSICAL DEMANDS AND WORKING CONDITIONS:

Company info

Renal Advantage Inc.
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Company Profile
Through our leading network of more than 2,100 dialysis facilities in North America and our vascular access centers, laboratory, pharmacy and affiliated hospitals and nephrology practices, Fresenius Medical Care provides renal services to hundreds of thousands of people throughout the United States, Mexico and Canada. We are also the continent's top producer of dialysis equipment, dialyzers and related disposable products and a major supplier of renal pharmaceuticals.

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