Job Title

Clinical Trial Assistant Job Accountabilities Interact with study Sponsors, investigational sites, vendors, and Everest functional groups to enable timely and high-quality operationalization of clinical trials in compliance with ICH-GCP and relevant local regulations. Compile documentation for qualification of clinical sites. Support review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations. Assist with preparation and submission of regulatory documents to responsible authorities and Institutional Review Boards/Ethics Committees. Responsible for set-up, maintenance, and archival of studies in the Trial Master File (TMF) and Clinical Trial Management System (CTMS). Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in TMF. These files must be maintained in a fashion so that they are continuously available for inspection and completion for archive. Assist with site identification, feasibility questionnaire development and distribution, and site selection. Contribute to the development of Clinical Operations documents (i.e., Investigator Site File logs, newsletters, etc.) to facilitate the implementation and management of the clinical trial. Collaborate with meeting planners and vendors to arrange for Investigator meetings, off-site client meetings (i.e., kick-off meetings), or internal departmental meetings. Responsible for the shipment and tracking of trial documents (site binders, manuals, guides, etc.) and supplies, as needed. Track monitoring plan compliance metrics (i.e., monitoring frequency and monitoring visit report submission/finalization). Issue reminders to monitoring team. Distribute Suspected Unexpected Serious Adverse Reactions (SUSARs) to investigational sites and complete necessary tracking (acknowledgement of receipts, etc.). Assist with the download of reports from Electronic Data Capture (EDC) systems and Interactive Web Response Systems (IWRS) to prepare summary of data for Project Managers/Clinical Trial Managers. Maintain study portals, web sites, or newsletters. Compile reports progress/status of investigational sites. Assist with processing of vendor/site invoices and Investigator site payments. Participate in the development and maintenance of and adhere to departmental Standard Operations Procedures (SOPs) and guidelines. Collaborate with other team members to prepare, maintain, and complete training on study-specific and/or applicable Sponsor SOPs. Support sites and internal Clinical Operations efforts to prepare for inspections and/or audits conducted either by Everest, Sponsors, or regulatory authorities. Assist Clinical Operations team members with Requests for Proposals and other Clinical Operations tasks as needed. Provide support for Clinical Operations and other functional areas as needed. Qualifications Bachelors degree in Life Sciences or related field of study. Excellent communication (both verbal and written) and computer skills. Expert use of the Microsoft Office suite is essential. Minimum of 1 year of experience in administrative support preferred. Experience in managing and maintaining electronic TMFs. Thorough knowledge of ICH-GCP guidelines and applicable regulations. Ability to travel a maximum of 5% of working hours is required. Benefits & Compensation We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary Range: $45,000 - 65,000. Equal Opportunity Statement Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #J-18808-Ljbffr