Clinical Affairs/Research Associate (Hybrid)

Tyber Medical - Bethlehem, PA

Full-time - Mid Level

Bethlehem, PA

Miscellaneous Manufacturing

About the position

The Clinical Affairs / Research Associate will be integral to the execution of clinical registries and post-market surveillance activities within the regulatory and clinical affairs team at Tyber Medical LLC. This role focuses on coordinating and supporting clinical research to ensure product safety, efficacy, and regulatory compliance, while also assisting in the planning and execution of Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF), and other regulatory documentation.

Responsibilities

• Assist in the planning and implementation of clinical research protocols.
• Coordinate with clinical sites to facilitate subject recruitment and retention strategies.
• 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.
• Maintain and oversee study documentation, including source documents and regulatory files.
• Ensure accurate data collection, entry, and quality control, and perform data analysis.
• Conduct regular site reviews of clinical data and inform the study management team on items requiring resolution.
• Assist in the preparation and submission of clinical study documentation, including CERs and study reports.
• Support the preparation of clinical data for regulatory submissions, including FDA submissions and CE mark applications.
• Assist with PMCF activities to collect data on the long-term safety and effectiveness of medical devices post-market release.
• Support the tracking and reporting of clinical outcomes post-launch.
• Assist in the creation and execution of Clinical Evaluation Plans (CEP) for medical devices.
• Contribute to the preparation of Periodic Safety Update Reports (PSUR) and PMSR, ensuring accurate summarization of safety and performance data.
• Ensure compliance with federal, state, and local regulations, ICH-GCP guidelines, and ISO standards.
• Assist with IRB and Ethics Committee submissions, including protocol amendments and adverse event reporting.
• Prepare study updates and metrics for stakeholders and participate in regular study team meetings.
• Collaborate with internal teams and external partners to ensure smooth execution of clinical studies.

Requirements

• 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 or healthcare industry.
• Strong understanding of regulatory compliance and clinical research methodologies.
• 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.

Nice-to-haves

• Certification in GCP
• Experience with medical device writing and clinical trials
• Familiarity with data analysis software and medical terminology

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Flexible scheduling
• Professional development opportunities