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Custom Search Inc. is seeking a Clinical Specialist II to support multi-center clinical trials and early commercial activities.
You will drive patient enrollment, support complex cases, and deliver site initiation visits and ongoing training for physicians and coordinators. The role requires active licensure (e.g., RN, RRT), 5+ years in clinical research or ICU/respiratory care, strong GCP/ISO 14155 knowledge, and travel up to 50%.
Our smaller medical device client is adding a Clinical Specialist II to the team. This is a critical, field-facing role supporting multi-center clinical trials and early commercial activities. This position drives patient enrollment, supports complex cases, and ensures clinical studies are conducted in accordance with GCP, ISO 14155, and regulatory requirements. You will serve as a clinical expert at trial sites, partnering closely with investigators, coordinators, and internal cross-functional teams to ensure strong execution and sustainable enrollment. Reports to the Director of Clinical Support and works with 2 other Clinical Specialists. There are 9 patients left on the premarket trial, and they will then transition to the post-market trial.
Clinical & Trial Support
Support patient cases and provide device troubleshooting and therapy guidance
Drive enrollment across multi-center clinical trials
Deliver site initiation visits, ongoing training, and education for physicians, RNs, RRTs, and coordinators
Maintain strong working knowledge of respiratory, ICU, ventilation, and related therapeutic landscapes
Ensure compliance with GCP, regulatory standards, and company SOPs
Site Relationship & Enrollment Leadership
Build and nurture relationships with PIs, KOLs, and site staff
Conduct regular in-field visits and virtual check-ins to promote sustained enrollment
Collaborate with Clinical Operations on trial execution and site performance
Provide feedback to improve recruitment strategies and training materials
Internal Collaboration
Partner cross-functionally with Clinical Operations, Regulatory, Engineering, and Marketing
Mentor junior Clinical Specialists as needed
Provide regular updates to Clinical Leadership
Bachelor’s degree in Nursing, Respiratory Therapy, Medicine, Biology, or related
Active clinical licensure (e.g., RN, RRT) required
5+ years combined experience in clinical research, ICU/respiratory care, or clinical field support
Strong knowledge of GCP and ISO 14155
Ability to travel up to 50%
Proven ability to operate independently in a fast-paced, growth-stage environment