Clinical Affairs Associate

This is a fully remote position, open to applicants in Oklahoma.

📋 Description

• Oversee the daily operations of clinical studies, ensuring the tracking of timelines, milestones, deliverables, and deviations.

• Facilitate communication and onboarding processes for clinical study sites, which includes scheduling, correspondence, and the distribution of study materials.

• Assist with clinical site monitoring tasks, such as preparing for monitoring visits, reviewing source documents, and verifying data accuracy against case report forms (CRFs).

• Support data collection, entry, and organization for clinical validation and post-market studies.

• Prepare, organize, and format documentation necessary for regulatory submissions.

• Maintain study trackers, files, and records in the clinical study management system.

• Aid in managing vendor and site logistics, including the shipment of study supplies and collection of required documentation.

• Prepare materials and notes for Advisory Team meetings and communications with Key Opinion Leaders (KOLs).

• Conduct literature reviews and background research that contribute to study design and the clinical value proposition.

• Assist with or independently conduct routine clinical site monitoring visits as experience permits.

• Perform source data verification, identify discrepancies, and follow up on monitoring findings.

• Support study start-up activities, including site qualification, preparation for initiation visits, monitoring reports, and follow-up correspondence.

• Track enrollment, data-entry timelines, and query resolution while escalating any risks identified.

• Carry out literature searches and reviews for marketed products as part of post-market surveillance (PMS) activities.

• Help compile and draft periodic PMS reports in collaboration with Quality/Regulatory Affairs.

• Monitor and analyze complaint, adverse-event, and field-performance trends to identify emerging signals.

• Keep PMS plans, trackers, and supporting files in an audit-ready state.

• Stay updated on relevant FDA, EU IVDR, ISO 13485, and ISO 14971 developments.

• Organize inputs for periodic safety update reports and other PMS regulatory deliverables.

⛳️ Requirements

• A Bachelor's degree in life sciences, public health, or a related discipline.

• At least 2 years of experience in clinical research, IVD, or a comparable healthcare/laboratory environment.

• Familiarity with clinical site monitoring and/or study data management, including source data verification, CRF review, or support during monitoring visits.

• Strong organizational abilities and keen attention to detail.

• Capability to manage multiple study timelines and meet reporting deadlines.

• Excellent written and verbal communication skills.

• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

• Understanding of Good Clinical Practice (GCP).

• Knowledge of post-market surveillance and quality standards, including ISO 13485, ISO 14971, and IVDR.

• Flexibility to adapt to changing tasks and responsibilities.

• Proven experience of collaboration and accountability in the workplace.

• Willingness and ability to travel as required for on-site clinical monitoring visits.

• Coordinator-level experience in clinical research is preferred.

• Previous experience in clinical site monitoring is preferred.

• Familiarity with data management, clinical study management, or literature database tools such as PubMed is preferred.

• Employment offers are contingent upon obtaining clear and acceptable results from background checks.

🏝️ Benefits

• Remote-eligible position.

• Equal employment opportunity and nondiscrimination protections.

• Background checks conducted in compliance with EEOC and FCRA regulations.