Clinical Trial Associate
• Be accountable for providing logistical support for a clinical program and associated clinical trials
• Be accountable for delivery of complete Trial Master File (TMF) for assigned studies or program Be responsible for the collection, review and tracking of regulatory documents for assigned clinical studies
• Be responsible for the timely and accurate input of study-related information into Impact
• Be responsible for preparation and distribution of regulatory and operational binders/manuals and clinical system set-up
• Provide oversight and quality assessment of document standards, tools and processes at the program level
• Assist in the preparation of study-related operational manuals and initial regulatory documents and distribute to investigator sites and/or the CRO; prepare study documents (e.g., visit logs, drug inventories, spreadsheets) using approved global templates.
• Ensure complete and timely collection and archiving of TMF documents for assigned studies or program.
• Collect, review and track site-specific regulatory documents; prepare final clinical trial material document package for initial drug shipments (green light procedure).
• Support the study team with set-up and maintenance of study related clinical systems (IVRS, CTM, IMPACT, payments, etc.).
• Process and track clinical trial material requests, study related supply requests (other
• BA/BS/BSN degree required.
• At least 3 years previous experience in the healthcare field; pharma experience strongly preferred; with a basic understanding of drug development and knowledge of ICH and GCP guidelines desired.
• Must have good interpersonal, written and verbal communication skills and strong computer skills.
• Fluent in English.
• Should be a team player capable of working in a multi-cultural environment.
Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.
Mon, 9 Oct 2017 13:23:23 PDT