Clinical Affairs Associate

Clinical Affairs Associate

This is a remote-eligible position, requiring the candidate live within the U.S.

The Clinical Affairs Associate supports the CARE team's evidence generation work by assisting with the day-to-day coordination of clinical studies - study site communication, documentation, data collection, and preparation of regulatory-grade materials - and by supporting post-market surveillance (PMS) activities for IMMY's commercialized products. Working under the direction of the Clinical Affairs Lead and in close partnership with the Clinical Research Specialist, this role helps ensure clinical studies and PMS obligations stay organized, on track, and audit-ready, so the team can deliver the evidence that proves IMMY's diagnostics solve real clinical problems and continue performing safely in the field. This role also draws on a clinical research background to support clinical site monitoring, data monitoring, and study management activities as needed.

Key duties and responsibilities include:

• Assist with day-to-day coordination of clinical studies, including tracking timelines, milestones, and deliverables, and flagging deviations to the Clinical Affairs Lead or Clinical Research Specialist.
• Support clinical study site communication and onboarding scheduling, correspondence, and distribution of study materials to investigators and site staff.
• Support clinical site monitoring activities as needed, including scheduling and preparing for monitoring visits, reviewing source documentation, and helping verify data accuracy against case report forms (CRFs).
• Assist with data collection, entry, and organization for clinical validation and post-market studies, supporting the Clinical Affairs Specialist's data quality checks.
• Help prepare, organize, and format supporting documentation for regulatory submissions under the direction of the Clinical Affairs Lead.
• Maintain and update study trackers, files, and clinical study management system records.
• Support vendor and site logistics, including shipment of study supplies and collection of required documentation.
• Help prepare materials and notes for Advisory Team meetings and communications with key opinion leaders (KOLs).
• Conduct basic literature and background research to support study design and clinical value proposition work.
• Any other duties as assigned.

Study Monitoring & Data Management Support (as needed):

• Assist with or, as experience allows, independently conduct routine clinical site monitoring visits (on-site or remote) to check protocol compliance, informed consent documentation, and data quality.
• Perform source data verification (SDV) against case report forms and help identify, document, and follow up on data discrepancies and monitoring visit findings.
• Support study start-up activities such as site qualification and initiation visit preparation, and help draft monitoring visit reports and follow-up letters.
• Track enrollment, data entry timelines, and query resolution across active studies, escalating risks to the Clinical Affairs Lead.

Post-Market Surveillance (PMS) Support:

• Conduct ongoing literature searches and reviews for marketed products, screening for new clinical, safety, or performance data relevant to IMMY's PMS obligations.
• Help compile and draft periodic PMS reports under the direction of the Clinical Affairs Lead and in coordination with Quality/Regulatory Affairs.
• Support tracking of complaint, adverse event, and field performance trends alongside literature findings to help identify emerging signals for review.
• Help maintain PMS plans, trackers, and supporting files so records stay current and audit-ready.
• Monitor and help summarize updates to relevant regulatory and quality requirements (e.g., FDA, EU IVDR, ISO 13485, ISO 14971) that affect PMS activities, flagging changes to the Clinical Affairs Lead.
• Assist with gathering and organizing inputs for periodic safety update reports and other PMS-related regulatory deliverables.

Qualifications:

Required:

• Bachelor's degree in life sciences, public health, or a related field.
• 2+ years of experience in clinical research, in vitro diagnostics (IVD), or a related healthcare/lab setting, including some exposure to clinical site monitoring and/or study data management (e.g., source data verification, CRF review, monitoring visit support).
• Strong organizational skills and attention to detail; comfortable managing multiple study timelines and reporting deadlines at once.
• Clear written and verbal communication skills, including summarizing literature and data clearly for cross-functional stakeholders.
• Working knowledge of Microsoft Office applications: Word, Excel, PowerPoint, and Outlook.
• Working knowledge of Good Clinical Practice (GCP) and post-market surveillance/quality requirements (e.g., ISO 13485, ISO 14971, IVDR), as they apply to clinical study designs, clinical site monitoring, and data quality oversight.
• Adaptable to changing tasks and assigned responsibilities.
• A proven track record of working collaboratively and being accountable.
• Willingness and ability to travel as needed to support on-site clinical monitoring visits.

Preferred:

• Coordinator-level clinical research experience.
• Prior experience conducting or supporting clinical site monitoring visits (e.g., as a CRA, clinical research coordinator, or monitoring assistant).
• Familiarity with data management, clinical study management software, or literature database tools (e.g., PubMed).

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.