Clinical Affairs Associate

🔥 0 minutes ago

🌪️ Oklahoma – Remote

🌪️ Oklahoma – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

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IMMY

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1979

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

IMMY is a company that expands its diagnostic capabilities through the acquisition of OLM Diagnostics, focusing on innovative molecular diagnostics. With a strong emphasis on fungal infections, IMMY offers a range of products including lateral flow assays and enzyme immunoassays to aid in the accurate and timely diagnosis of various fungal diseases. Committed to improving patient care worldwide, IMMY leverages over 40 years of experience in the field to provide reliable testing solutions to healthcare professionals across more than 80 countries.

📋 Description

• Coordinate day-to-day clinical studies, tracking timelines, milestones, deliverables, and deviations • Support clinical study site communication and onboarding, including scheduling, correspondence, and study-material distribution • Support clinical site monitoring, including monitoring-visit preparation, source-document review, and data-accuracy verification against CRFs • Assist with data collection, entry, and organization for clinical validation and post-market studies • Prepare, organize, and format documentation for regulatory submissions • Maintain study trackers, files, and clinical study management system records • Support vendor and site logistics, including shipment of study supplies and collection of required documentation • Prepare materials and notes for Advisory Team meetings and KOL communications • Conduct literature and background research supporting study design and clinical value proposition work • Assist with or independently conduct routine clinical site monitoring visits as experience allows • Perform source data verification, identify and follow up on discrepancies and monitoring findings • Support study start-up, site qualification, initiation-visit preparation, monitoring reports, and follow-up letters • Track enrollment, data-entry timelines, and query resolution, escalating risks • Conduct literature searches and reviews for marketed products as part of PMS activities • Help compile and draft periodic PMS reports with Quality/Regulatory Affairs • Track complaint, adverse-event, and field-performance trends to identify emerging signals • Maintain PMS plans, trackers, and supporting files in audit-ready condition • Monitor and summarize relevant FDA, EU IVDR, ISO 13485, and ISO 14971 updates • Organize inputs for periodic safety update reports and other PMS regulatory deliverables

🎯 Requirements

• Bachelor's degree in life sciences, public health, or a related field • 2+ years of experience in clinical research, IVD, or a related healthcare/lab setting • Exposure to clinical site monitoring and/or study data management, including source data verification, CRF review, or monitoring-visit support • Strong organizational skills and attention to detail • Ability to manage multiple study timelines and reporting deadlines • Clear written and verbal communication skills • Working knowledge of Microsoft Word, Excel, PowerPoint, and Outlook • Working knowledge of Good Clinical Practice (GCP) • Working knowledge of post-market surveillance and quality requirements, including ISO 13485, ISO 14971, and IVDR • Adaptability to changing tasks and responsibilities • Proven collaborative and accountable work history • Willingness and ability to travel as needed for on-site clinical monitoring visits • Coordinator-level clinical research experience preferred • Prior clinical site monitoring experience preferred • Familiarity with data-management, clinical study management, or literature-database tools such as PubMed preferred • Employment offers are contingent upon clear, acceptable background-check results

🏖️ Benefits

• Remote-eligible position • Equal employment opportunity and nondiscrimination protections • Background checks conducted in compliance with EEOC and FCRA regulations