Clinical Research and Document Control Coordinator

Clinical Research and Document Control Coordinator At Confer Health, we empower people to make health decisions with confidence by giving everyone access to clinical-grade testing at home. This is enabled by our unique technology that is orders of magnitude more sensitive and more affordable than what's available at hospitals or clinical labs. Our ambition is to usher in an era of proactive medicine so we can all get the care we need before it's too costly or too late. We're a small, world-class team combining Silicon Valley urgency with East Coast science. We recently closed a large Series A led by one of Silicon Valley's best investors and we're looking for a dynamic and resourceful person to help run our clinical trials and manage our document control system. We value diversity and all qualified candidates are invited to apply. The Clinical Research/Document Control Coordinator position at Confer Health will fall under the Clinical/Regulatory Department and report to the Clinical Research/Quality Manager. Responsibilities (Clinical) Work with the team to design and implement clinical studies related to the Strep Throat Detection Kit and oversee the following: Study Subject Recruitment and Enrollment (all advertising and consenting) Order and maintain all study equipment and supplies Track all research expenses Maintain relationship and training with clinics and laboratories (frequent auditing) Daily auditing of Informed Consent Forms and Case Report Forms Compile, analyze and present clinical study data Develop protocols/study materials and submissions to the IRB As needed, provide support to your teammates working on the clinical trials related to the Complete Fertility Kit. Responsibilities (Quality) Implement, maintain and continuously improve Confer document controls, processes, procedures, and training to ensure FDA QSR, ISO 13485, and/or other applicable standards are continuously met. Ensure that the team is always accessing the latest and approved versions of documents Maintain the Confer Master Document List (MDL). Identify, record, track, and review change- management and document initiation per governing procedures. Work with the Quality Manager to generate and release Document Change Orders (DCO)s quickly to ensure that the team can continue to make progress. Maintain DCO log and manage DCOs through approval and release. Develop systems to ensure that our records are secure and only accessible by appropriate individuals while remaining easily retrievable. Host training for new staff and newly released DCOs. Work closely with Laboratory Manger to maintain equipment and vendor files. Maintain a Device History Record (DHR) for each lot of product released for sale. Ensure records are retained per defined records retention schedule. Review prints, data, procedures, and test protocols/ reports to ensure they are accurate and that they comply with the technical application of standards (ISO, AAMI, ASTM, and IEC). YourMembership_RPM.Category: Administrative, Keywords: Document Control Administrator

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