Clinical Research Associate

Clinical Research Associate - Jacksonville, FL

Kelly Scientific Resources (KSR), a division of Kelly Services, is recognized as a leader in the staffing industry, with temp, temp-to-hire, and direct hire opportunities at a variety of companies. To satisfy our clients needs, we work with the best people in the scientific community. That's where you come in. KSR is currently seeking a Clinical Research Associate to work for our client in Jacksonville, FL. This is a 4 month contract opportunity and is a great chance to work in an innovative and exciting environment! DESCRIPTION: The CRA will plan and monitor human clinical trials in compliance with internal procedures, ICH Guidelines, Good Clinical Practices (GCP) and applicable Regulations and Guidelines. Coordinates protocol and case report form development and compilation. Insures appropriate clinical trial agreements are signed and materials are distributed. Monitors and secures protocol and regulation compliance at investigational sites. Reviews, retrieves, and reports the trial data as the requirements dictate or as is appropriate. Maintains essential documents and other study-related documents. Plans and develops complex study protocols/technical reports, develops, tests, and reviews CRFs and other study materials. Assists in study implementation, which may include: investigator recruitment, site management, IRB liaison, Adverse Event management, Periodic Report generation, and/or supplier oversight. Performs other related duties as assigned by management, including process improvements and coaching new employees. May draft informed consents, protocols, sections of Investigator Brochures, and other study documents. Will oversee internal and contract monitors, review clinical data, complete trend analysis, communicate study progress, risk, and best practices to study team. Coordinate and communicates with universities, contract research organizations, private practices, institutional review boards, and other functional groups engaged in the conduct of clinical studies. RESPONSIBILITIES: Conduct clinical monitoring of company sponsored studies remotely and on-site as required. Travel to clinical sites or vendors up to 70% of time. (70%) Support the management of clinical studies according to agreed timelines. (20%) Organize and analyze data and identify trends, manage risk, and offer solutions. (15%) Oversee contract research organizations, communicate with clinical sites, and partner with internal study teams (10%) Performs other related duties as assigned by management. (5%) QUALIFICATIONS: Bachelor?s Degree in the sciences. Minimum of 2 years within a pharmaceutical, biotechnology, or contract research organization. A minimum of one year experience as a Clinical Research Coordinator or in-house or regional CRA. Excellent communication, organizational, negotiation and interpersonal skills. Must have in depth knowledge of the Code of Federal Regulations related to clinical research, ICG GCP guidelines, and other applicable regulations and practices. Working knowledge, understanding and application of principles, concepts and practices of clinical and/or consumer research, experimental design and statistical analysis. Ability to prioritize and handle multiple tasks and to facilitate and resolve cross-functional activities and issues. Fluency in one or more foreign languages desired. If you meet the requirements and you are interested in this rewarding opportunity please click the ?Apply Now? button to be considered for this immediate opening. We look forward to hearing from you! Due to the overwhelming amount of applications we receive, we are only able to respond to those that meet the requirements for this position. We appreciate your interest in working with Kelly Scientific Resources! Discover great opportunities with Kelly Scientific Resources (KSR). KSR, a division of Kelly Services, is recognized as a leader in the staffing industry, partnering with a variety of industries. To satisfy our clients needs, we work with the best people in the scientific community. Our experienced staff identifies and employs top-notch talent and our unique training provides outstanding long-term opportunities for career development. We offer a full-range of scientific staffing options, from entry-level to PhD in temporary, temp to hire, and direct placement positions. Kelly Services is an equal opportunity employer.