Clinical Operations Specialist
E
Element Science, Inc.Medical Device
Location: RemoteFull-TimeMiddle
Salary$26 - $31 per hour
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Job Details
- Experience
- 3+ years of experience in clinical operations, clinical research, patient studies, medical device studies, or a related healthcare environment.
- Required Skills
- Project Coordination
Requirements
- Bachelor’s degree in life sciences, nursing, clinical research, biomedical sciences, engineering, or a related discipline.
- 3+ years of experience in clinical operations, clinical research, patient studies, or medical device studies.
- Working knowledge of Good Clinical Practice (GCP) guidelines and FDA/European regulations for medical device trials.
- Experience coordinating clinical studies, human factors studies, or usability studies.
- Strong project coordination skills with the ability to manage multiple studies and deadlines.
- Exceptional attention to detail and ability to maintain accurate study documentation.
- Strong communication skills for effective interaction with patients, healthcare professionals, and stakeholders.
- Strong problem-solving skills and ability to exercise sound judgment.
- Ability to work independently within a fast-paced, cross-functional environment.
- Experience with clinical data management, trial master files, and electronic data capture (EDC) systems.
- Ability to travel as required to support clinical sites and study activities.
Responsibilities
- Coordinate and oversee the day-to-day execution of clinical, human factors, and other research studies from study initiation through closure.
- Support development of study plans, protocols, procedures, study materials, case report forms, and trial master files.
- Serve as a primary operational point of contact for study participants, clinical sites, investigators, and vendors.
- Coordinate participant recruitment, screening, scheduling, enrollment, and study follow-up activities.
- Ensure study activities are conducted according to approved protocols, internal procedures, and Good Clinical Practice (GCP).
- Maintain accurate, audit-ready study documentation, including participant records, logs, and tracking tools.
- Track study milestones, enrollment, and deliverables; escalate risks or potential delays.
- Support collection, review, and maintenance of clinical data to promote data integrity.
- Coordinate preparation, shipment, and accountability of study devices and materials.
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