FSP Assistant CRA (Inhouse CRA) (Sponsor: Roche)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description FSP Assistant CRA (Inhouse CRA) (Sponsor: Roche) Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned. Completes and documents study-specific training. Orients and trains on any CRG/study-specific systems. Provides in-house support during pre-study assessments and with pre-study asssessment waivers, as agreed for project. Supports to customize Site ICF with site contact details, as needed. Reviews patient facing materials and review translations, as directed. Supports site staff with the vendor related qualification process, where applicable. Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study. Provides support to follow-up on site staff training, as appplicable. Coordinates and supports logistics for IM attendance, as directed. Supports maintenance of vendor trackers, as directed. Coordinates study/site supply management during pre-activation and subsequent course of the study. Supports Essential Document collection, review and updating in systems, as applicable. Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed. Supports ongoing remote review of centralized monitoring tools, as directed. Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period. Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable. Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed. Knowledge and Skills: Basic medical/therapeutic area knowledge and understanding of medical terminology Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and CRG procedural documents Effective oral and written communication skills Excellent interpersonal and customer service skills Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively Proven flexibility and adaptability Ability to work in a team or independently, as required Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards Excellent English language and grammar skills Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. 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