Ref No.: 18-09142
Location: Cambridge, Massachusetts
Start Date: 07/25/2018
Job Responsibilities: • Performs study tracking to ensure that all study files and documents are accurate, current and complete • Performs essential document collection, review, maintenance, and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs. • Provides general support to the Lead CRA in order to manage the investigator sites and ensure compliance • Performs recruitment plan review and provides regular enrollment updates • Addresses protocol questions and issues from investigational sites visits • Performs regular reviews of data according to data review/monitoring guidelines • Assists with resolution of investigational site/data queries. • Confirms and track that all key site personnel have project specific training. • Documents site and sponsor contact and study interactions in a timely and professional manner. • Provides assessment of sample status • Monitors tracking systems (CTMS, TMF, etc) Education • Bachelor's degree, in biological sciences or healthcare • 5+ years clinical trial experience (CRO, healthcare settings and industry experience are acceptable). • Excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail. • Strong computer proficiency in MS Office including Word, Excel, and PowerPoint. • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines. • Excellent organizational and record-keeping skills. • Ability to maintain excellent working relationships with a broad range of trial staff. • Knowledge of GCP as relates to clinical trial management • Ability to work well in a team environment but also independently without significant oversight. Flexibility in work hours and readiness to travel