Job Type Full-timeDescriptionThe Clinical Affairs / Research Associate will play a vital role in the successful execution of clinical registries and post-market surveillance activities within our regulatory and clinical affairs team. This position focuses on coordinating andsupporting clinical research to ensure product safety, efficacy, and regulatory compliance as well as supporting the planning, and execution of Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF), Clinical Evaluation Plans (CEP), and Periodic Safety Update Reports (PSUR) / Post-market surveillance reports (PMSR). The ideal candidate should possess a strong understanding of regulatory compliance and clinical research methodologies. Effective collaboration with internal teams, research sites, and regulatory bodies is crucial to ensure all activities adhere to regulatory requirements, Good Clinical Practice (GCP), and company standards. RequirementsStudy Coordination and Management
- Assist in the planning and implementation of clinical research protocols.
- Coordinate with clinical sites to facilitate subject recruitment, retention strategies, and support overall study enrollment goals.
- Support day-to-day operations of assigned studies, ensuring adherence to protocol requirements, and timelines.
- Act as a contact for site staff and ensure clear communication regarding study updates.
Data and Document Management
- Maintain and oversee study documentation, including source documents and study regulatory files.
- Ensure accurate data collection, entry, and quality control, perform data analysis, and working closely with the study management team to resolve discrepancies.
- Conduct regular site reviews of clinical data and information the study management team on items requiring resolution.
- Assist in the preparation and submission of clinical study documentation, including Clinical Evaluation Reports (CERs), study protocols, and study reports. Support the preparation of clinical data for regulatory submissions, including FDA submissions and CE mark applications.
- Assist with Post-Market Clinical Follow-up (PMCF) activities to collect data on the long-term safety and effectiveness of medical devices after market release. Support the tracking and reporting of clinical outcomes post-launch.
- Assist in the creation and execution of Clinical Evaluation Plans (CEP) for new and existing medical devices, including designing strategies to collect relevant clinical data and determining appropriate methodologies for product assessment.
- Contribute to the preparation of Periodic Safety Update Reports (PSUR) / Post-market surveillance reports (PMSR), ensuring that all safety and performance data from clinical studies and post-market surveillance are accurately summarized and reported in accordance with regulatory requirements.
Regulatory and Compliance
- Ensure that all study-related activities comply with federal, state, and local regulations ICH-GCP guidelines, ISO 14155, applicable FDA, ISO 13485, and MDR regulations.
- Assist with Institutional Review Board (IRB) and Ethics Committee submissions, including protocol amendments, adverse event reporting, and study renewals.
- Assist with the preparation and submission of regulatory documents for clinical trials and post-market surveillance reports.
- Maintain up-to-date knowledge of industry standards and regulatory requirements to ensure adherence to guidelines and internal policies.
Communication and Reporting
- Prepare study updates and metrics to internal and external stakeholders.
- Participate in regular study team meetings to discuss trial progress, challenges, and improvements.
- Contribute to the preparation of study reports, regulatory submissions, and manuscripts, as needed.
Cross-functional Collaboration
- Work closely with internal teams (e.g., Regulatory Affairs, Quality Assurance, Product Development, etc.) and external partners (e.g., clinical research sites, CROs, investigators, and study participants) to ensure smooth execution of clinical studies and timely delivery of required reports.
- Collaborate with sites to address any logistical or administrative issues that may arise.
Preferred Skills
- Certification in GCP
- Experience with medical device writing and clinical trials
- Familiarity with data analysis software and medical terminology
Qualifications
- Bachelor's degree in life sciences, healthcare, or a related field
- 1-2 years of experience in clinical research/clinical affairs, within the medical device, healthcare industry, or CRO setting.
- Knowledge of FDA, EU MDR, ICH-GCP, ISO 14155, IRB, and ISO 13485 regulations.
- Proficient in Electronic Data Capture (EDC) systems and clinical trial management software.
- Excellent organizational skills with the ability to manage multiple tasks and prioritize effectively.
- Strong written and verbal communication skills, with attention to detail in documentation.
- Ability to work independently and as part of a cross-functional team in a fast-paced environment.