Clinical trial associate, clinical operations
Agios (agios.com) is a biopharmaceutical company focused on providing medicines for some of the world’s most challenging diseasesWe’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (gdd), encompassing both rare and more common diseases, and mining the extensive potential in the pk platformWe are leading the way in advancing pkr activation for hemolytic anemias, including pyruvate kinase (pk) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communitiesWe continue to foster a productive research engine that yields new insights and potential therapeutic approachesWe’re a company that cares about our work, each other, and the people who are counting on us the mostWe’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary resultsWe’re driven to be our best selves, together, so we can reach for the other side of possible.
Agios pharmaceuticals is seeking a collaborative and thoughtful clinical trial associate to administer, maintain and coordinate the logistical aspects of clinical trials at agios as well as support other projects (ie, observational studies, collaborative investigator sponsored trials)The cta position is focused on meetings providing support during clinical study planning and execution to include: management of project development and production of timelines, budgets, and various study plansThe incumbent maintains focus on intended timelines and achievement of study goals while ensuring quality in accordance with fda, ema, gcp, and ich guidelines.
Remote candidates are welcome to apply!
Key responsibilities
Collaborate with clinical operations trial manager(s) to assist in clinical trial management tasks (e.gTrip report review, issue tracking, and protocol deviation review)
Liaise with cros and other clinical vendors to ensure deliverables are met and communication is efficient
Partner with investigators and clinical site staff to ensure optimal sponsor-site relationships
Assist in the management of study to ensure adherence to timelines and achievement of study goals while ensuring high quality
Identify clinical study and investigative site risks and propose corrective actions, where applicable
Coordinate the logistical aspects of investigator meetings
Provide input during clinical study budget(s) reconciliation
Assist in the development of critical study documents
Assist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples
Provide oversight of activities related to safety reporting
Reviews and maintains study-level training documentation
Reviews study-specific essential regulatory document packets prior to site activations
Acts as functional tmf document specialist for clinical operations, to include submission of documents to and maintenance of the tmf; reviews tmf documents as part of the quality review process; acts as primary liaison with the cro to collect trial documents and coordinate review of the electronic tmf to ensure inspection-readiness at all times
Manages insurance certificate requirements
Obtains and disseminates schedules and calendars; prepares and distributes agenda and minutes and action items for project team meetings and client meetings
Minimum requirements
Bachelor`s degree is required; scientific/health care field preferred, but not required
Minimum of 2 years’ experience in relevant field (e.gClinical site, cro, sponsor or clinical trial vendor)
Strong skills in collaboration, communication, organization, attention to detail and multi-tasking
Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency
Understanding of ich-gcp guidelines, clinical trial monitoring, and/or regulatory compliance preferred
Must be comfortable working in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
