Clinical Trial Assistant w/Phase III Cardiovascular Experience Job in Durham, North Carolina US
Clinical Trial Assistant w/Phase III Cardiovascular Experience
Kelly Clinical Research has a new opening for an experienced Clinical Trial Assistant to provide support to an extremely busy Phase III Cardiovascular mega trial. This is a one year contract with the possibility of extending. The CTA will provide site management, monitoring, and regulatory administrative and technical support in accordance with departmental and project-specific guidelines, SOPs, applicable regulations and ICH guidelines. Responsibilities include: · Working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, ICH-GCP, FDA regulations and/or the study sponsor · Maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial · Collection of site level critical documents for Investigational Product (IP) release and site activation · Review and approval of site level critical documents for Investigational Product release and site activation · Negotiation of site level contracts to ensure sites are activated within the agreed timelines · Where applicable, provide logistical support of clinical trial supply coordination · Coordination of investigator contracts in close collaboration with the internal legal department and the sponsor · Accountable for the preparation and coordination of submissions to regulatory, ethics and other bodies Requirements: · 2 year degree in clinical, health or life science and 2+ years minimum demonstrated clinical research experience · Knowledge of cardiovascular and Phase III clinical trials · Experience in contract negotiation · Knowledge of regulatory documents and GCP guidelines · Strong technical spelling and grammar skills · Ability to communicate and work productively in a team environment · Proficient computer skills including MS Word and Excel · Good organizational skills · Ability to follow instructions with minimal guidance If you are an experienced Clinical Operations professional in the RTP area and are looking for a new opportunity, please Apply Now! Note: Applicants must be immediately eligible to work for any employer in the U.S. without any restrictions. Kelly Clinical Research specializes in delivering clinical research workforce solutions to the world?s leading pharmaceutical, medical device, and biotechnology companies, as well as contract research and site management organizations. We provide contract, temp-to-hire and direct hire opportunities. Areas we specialize in include Clinical Research Associates (In-house and Field-based), Data Management, U.S. and International Regulatory Affairs, Biostatistics and Analysis, Medical Writing, Project Management, GCP Audit and Quality Assurance, Clinical Operations and Support. Kelly Services, Inc. is an Equal Opportunity Employer