Note: The job is a remote job and is open to candidates in USA. Cardiovascular Associates of America - CVAUSA is seeking a Clinical Research Assistant to provide operational and participant support for clinical research studies. The role involves coordinating participant appointments, processing specimens, maintaining study documentation, and ensuring compliance with protocol requirements.
Responsibilities
- Coordinate participant appointments and study visits
- Contact participants regarding upcoming visits and study requirements
- Assist with visit preparation and participant flow
- Maintain study calendars and visit schedules
- Support participant retention activities
- Maintain research supplies and study materials
- Order study-related supplies and equipment as directed
- Monitor inventory levels and maintain adequate stock
- Track expiration dates of study supplies and research materials
- Ensure study materials are organized and readily available
- Process biological specimens according to protocol requirements
- Prepare and package specimens for shipment
- Complete shipping documentation and laboratory requisitions
- Maintain specimen shipment records
- Coordinate with central laboratories and couriers
- Maintain temperature logs and equipment monitoring records
- Maintain medication accountability logs and inventory documentation
- Assist with essential study documentation
- Ensure logs are completed, accurate, and up to date
- Support filing and organization of study records
- Assist with document collection and filing
- Route study documents for review and signature
- Support maintenance of regulatory binders and electronic regulatory systems
- Assist with study start-up and close-out activities
- Follow protocol requirements, GCP, sponsor requirements, and site SOPs
- Escalate protocol deviations, equipment issues, or documentation concerns
- Participate in training and quality improvement activities
- Maintain confidentiality of participant and study information
Skills
- High School Diploma
- Strong organizational skills
- Ability to manage multiple priorities
- Attention to detail and accuracy
- Strong communication and customer service skills
- Ability to work independently and within a team environment
- Proficiency with Microsoft Office applications
- Ability to learn CTMS, EDC, and sponsor systems
- Ability to stand, walk, and move throughout clinical areas
- Ability to lift and transport study supplies and specimen shipments up to 25 pounds
- Ability to perform repetitive computer-based tasks
- Associate's or Bachelor's degree in a health science, biological science, or related field
- Previous healthcare, laboratory, administrative, or research experience
- Experience handling specimens or laboratory procedures
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