Clinical Operations Specialist

SUMMARY OF ROLE:

We are seeking a Clinical Operations Specialist to join our growing Clinical team. This role will be responsible for coordinating and overseeing the day-to-day execution of clinical, patient, and research studies supporting the development and evaluation of our medical device technologies.

Working closely with Clinical, Engineering, Quality, Regulatory, and other cross-functional partners, the Clinical Operations Specialist will help ensure studies are planned and conducted safely, efficiently, and in accordance with approved protocols and applicable procedures. This role will serve as a key operational point of contact throughout the study lifecycle, coordinating participants, investigators, clinical sites, vendors, documentation, study materials, and timelines.

This is an exciting opportunity for someone who enjoys working directly with patients and clinical partners while bringing organization, attention to detail, and operational excellence to studies that help improve the safety, effectiveness, and usability of our products.

RESPONSIBILITIES:

• Coordinate and oversee the day-to-day execution of clinical, human factors, and other research studies from study initiation through closure, including in-house and remote wear studies as well as the Jewel Post-Approval Study registry.
• Support development of study plans, protocols, procedures, study materials, case report forms, and other study documentation, including the development and maintenance of trial master files and EDC platforms.
• Serve as a primary operational point of contact for study participants and external study partners, including clinical sites, investigators, key opinion leaders, vendors, and internal teams, providing timely communication and coordinating study-related activities.
• Coordinate participant recruitment, screening, scheduling, enrollment, study visits, and follow-up activities in accordance with approved study protocols.
• Ensure study activities are conducted according to approved protocols, internal procedures, applicable regulatory requirements, and Good Clinical Practice (GCP), as appropriate.
• Maintain accurate, complete, and audit-ready study documentation, including participant records, study files, logs, tracking tools, and essential documents.
• Track study milestones, enrollment, participant status, study activities, deliverables, and timelines; proactively identify and escalate risks or potential delays.
• Support the collection, review, reconciliation, and maintenance of clinical and study data to promote completeness and data integrity.
• Coordinate the preparation, shipment, accountability, and return of study devices, supplies, and materials.
• Document and appropriately escalate study deviations, adverse events, product issues, participant concerns, and other study-related observations.
• Partner with quality and product development teams to communicate observations and feedback gathered during patient and clinical studies.
• Assist with preparation for study reviews, audits, inspections, and regulatory submissions as needed.
• Identify opportunities to improve and scale  clinical operations processes, study workflows, documentation, and participant experience.

QUALIFICATIONS:

• Bachelor’s degree in life sciences, nursing, clinical research, biomedical sciences, engineering, or a related discipline; equivalent relevant experience may be considered.
• 3+ years of experience in clinical operations, clinical research, patient studies, medical device studies, or a related healthcare environment. 
• Medical device industry experience is strongly preferred, particularly within a regulated product development or clinical research environment.
• Experience coordinating clinical studies, patient research, human factors studies, usability studies, or similar research activities. Experience with post-market registries preferred.
• Experience in clinical data management, including familiarity with trial master file structures and electronic data capture systems, strongly preferred.
• Experience working directly with patients, healthcare professionals, investigators, CROs, or clinical research sites preferred. 
• Working knowledge of Good Clinical Practice (GCP) guidelines, clinical research principles, and applicable FDA and European regulations and guidances pertaining to medical device clinical trials.
• Strong organizational and project coordination skills with demonstrated ability to manage multiple studies, participants, priorities, and deadlines.
• Exceptional attention to detail and commitment to maintaining accurate and complete study documentation.
• Strong written and verbal communication skills with the ability to effectively communicate with patients, healthcare professionals, vendors, and internal stakeholders.
• Strong problem-solving skills with the ability to identify issues, exercise sound judgment, and appropriately escalate concerns.
• Ability to work independently while collaborating effectively within a fast-paced, cross-functional environment.
• Comfortable working in a patient-facing environment and handling sensitive or confidential information appropriately.
• Ability to travel as required to support clinical sites, patient studies, and other study activities.

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO

The salary for this non-exempt level position will be based on experience and qualifications within an established pay range.

• Pay range: $26 - $31 per hour