Clinical Trial Coord. (12m) at Cambridge

Job Description

The Clinical Trial Coordinator (CTC) supports the Clinical Trial Manager (CTM) in planning and co-ordination activities around the clinical trial all operational aspects of a clinical project. He or she has the responsibility to support the project team to achieve quality results in a cost-effective timely manner. In doing this, the CTC represents i3 Pharma Resourcing and the sponsor to site personnel and colleagues with professionalism and integrity.Support the CTM and Study Management Team (SMT) in the successful execution of assigned clinical trials from protocol concept through to clinical study report, in compliance with international GCP guidelines/regulations and Standard Operating Procedures (SOPs).This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the postholder.Whilst at the company site, activities will include but are not limited to:Preparing Medical / Operational Assessment Consulting/Non-disclosure AgreementsCoordinating CDA preparation, collection and executionCollecting FDA 1572s and CVs from Principal Investigators for IND studiesCoordinating study critical meetings e.g. Investigator, Advisory, DSMC etcDistributing, collecting and reviewing Financial DisclosuresSetting-up, updating and maintaining the clinical trial management system e.g. IMPACTCreating, reviewing, approving, distributing and tracking Site Reference Materials e.g. Study Manual, Pharmacy Manual, Regulatory / Investigator BinderSourcing and distributing study supplies, as neededPreparing and maintaining Insurance certificatesDistributing recruitment materialsTracking protocol deviationsPopulating, distributing, reviewing and tracking all essential documents throughout the studyTracking investigational product and managing temperature excursionsTracking laboratory samplesSUSAR coordinationCreating and maintaining the companys CT.gov registry platformSupporting audit/inspection readinessEnsuring CCF completion and qualityCoordinating the final transfer of the CCF from the CRO(s)Delegating administrative tasks to the CTA as applicableBeing a knowledge resource to other CTCsAd hoc tasks as assigned by the i3 Site Manager.Qualifications:Bachelors level degree in life sciences, pharmacy or nursing preferred MUST HAVE ONSITE COORDINATOR EXPERIENCEGood experience within the Pharmaceutical/CRO industryStrong knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirementsGood experience working in a team across multiple functional areas (e.g., work with Quality Assurance, Data Management, Medical Affairs, Finance)Basic familiarity of statistics and statistical methodsDemonstrated ability to successfully supervise othersProven basic project management capabilitiesExcellent communication, relationship building and interpersonal skillsExcellent organizational skills and ability to prioritize and multi taskProficient in Microsoft Office (e.g., Word, Excel, and Outlook)ORL

Job Requirements

 
Country: USA, State: Massachusetts, City: Cambridge, Company: InVentiv Health.