Clinical Trial Associate 1 or 2
Core
Administrative and project tracking support for clinical trial operations, assisting teams in ensuring effective and efficient conduct of clinical research studies.
Role type
Clinical Trial Associate (IC)
Builds
Clinical trial operations support for neuroscience therapeutics (epilepsy, depression, pain)
Domain
Biopharmaceuticals / Clinical Development
Deliverable
client delivery
Required skills
Clinical trial processes knowledge, ICH-GCP guidelines, document review, regulatory document tracking, eTMF management, vendor coordination, invoice processing, meeting logistics, quality control of SOPs
Preferred skills
Experience in pharma/biotech or CRO, ability to manage multiple projects, proficiency in Microsoft Office
Technologies
eTMF systems, Microsoft Word, Excel, PowerPoint
Responsibilities
Review clinical documents (protocols, consents, study plans), assist in study start-up activities, develop and update trial tracking tools, support study master file and eTMF maintenance, collaborate with CROs and sites on day-to-day activities, track and process invoices, attend study meetings and assist with logistics, compile shipment requests to labs, monitor timelines and budgets, assist in planning investigator meetings, prepare documents for audits/inspections, perform QC review of study documents
Seniority
Individual Contributor (Level 1 or 2 based on experience)
