Clinical Trial Coordinator
: Job Details :

OverviewElement has a current opening for an on-site Clinical Trial Coordinator to join our growing team in Iowa. The Clinical Trial Coordinator will serve to coordinate the operational functions of all clinical trials (bacterial, fungal and molecular) for Element Iowa City. The position will be thelead point person to organize all aspects related to clinical trial services.ResponsibilitiesAssist directors with the development and review of protocols and lab manuals. This includes review of sponsor provided documents (synopses or full study approved protocols) and an understanding of lab procedures and workflow.Coordinate proficiency testing programs including College of American Pathology (CAP) and alternative proficiency testing including ensuring testing events performed for the year and at time of CAP shipments that review meetings are scheduled with sufficient time for testing and submission.Coordinate validation efforts for clinical trials testing including submission of validation plan and assistance with completion of validation reports.Maintain well-organized system monitoring clinical trials status including protocol, testing, billing, and payment status.Manage communications for clinical trials, including sample tracking, backup sample requests, attending established teleconferences, responding to email correspondence with sponsors and study sites, and providing status updates to Element Iowa City management team or sponsors.Prepare and ship required clinical trial kits to patient sites as needed, including initial enrollment kits as well as resupplies requested from sites. Assist other Managers with inventory monitoring and requisitioning of supplies needed for support kits and testing requirements including reconciliation and follow-up of documentation and samples.Coordinate and assign the testing of samples to meet contractual timelines.Review test results for completeness and liaise with directors on approving results to be released within the LIMS.Review all data discrepancies and monitor for accuracy.Attend investigator meetings and present training materials, including the microbiology manual, to ensure sites follow the recommended SOP to send clinical samples.Conduct in-service education and training to Element Iowa City testing personnel that are involved in the clinical trials support services, including those with minimal or no prior exposure to clinical trial SOPs.Assist IT staff in the development of each study in the LIMS, shipping manifest agreement, data transfer agreement(s), and provide feedback on required fields.Be familiar with Quality Assurance (QA) principles including deviations and nonconformances and assist with submission when involving clinical trials or proficiency programs.Understand regulatory requirements for GCP and CLIA. Be familiar with 21 CFR part 11 and computer system validation requirements.Work with QA to ensure regulatory compliance of clinical trials and participate in regulatory and sponsor audits.Be familiar with all relevant guidance or regulatory documents (i.e., CLSI, EUCAST, etc.) utilized in the laboratory testing processes.Skills / QualificationsA bachelor's, master's, or doctoral degree from an accredited college or university in a chemical, physical, biological, or clinical laboratory science, or medical technology.A demonstrated proficiency in communication (written and verbal), leadership, and collaboration, along with strong organizational skills.Prior experience in microbiology, clinical laboratory science, bacteriology, and/or mycology.At least one year of laboratory experience in high complexity testing and/or ability to qualify as a general supervisor under CLIA §493.1489(b). Prefer understanding of CLIA and GCLP guidelines.Experience in antimicrobial susceptibility testing or clinical trials testing is also preferred.Demonstrated proficiency in communication, organization, leadership, and collaboration is required.Company OverviewElement is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to Ë Make tomorrow safer than today'.When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.Diversity StatementAt Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming the world's most trusted testing partner  .All suitably qualified candidates will receive consideration for employment on the basis of objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)If you need an accommodation filling out an application, or applying to a job, please email Recruitment@.#J-18808-Ljbffr