Clinical Trial Coordinator - North Liberty - ref. y41731919

Overview:

The position will be the lead point person to organize all aspects related to clinical trial services.

Responsibilities:

• Assist 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

• 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 to be able to provide status updates to Element Iowa City management team or sponsors
• Prepare and ship required clinical trial kits to patient sites as needed, this includes 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
• Conducts 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. Is familiar with 21 CFR part 11 and computer system validation requirements
• Works 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 / Qualifications:

• A 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 working well and collaborating with

• 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 working well with others is required

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Company Overview:

Element 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 ‘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 Statement:

At 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 or other characteristics in accordance with the applicable governing laws.

41 CFR 60-1.35(c)

“If you need an accommodation filling out an application, or applying to a job, please email Recruitment@element.com”