Clinical Research Associate
Clinical Research Associate
Oricell Therapeutics
United States
See who Oricell Therapeutics has hired for this role
Position: Clinical Research Associate
Responsibilities:
- Serve as the primary contact for assigned clinical sites, facilitating communication and resolving issues.
- Manage patient enrollment, data entry, data monitoring, and safety reporting.
- Conduct Site Qualification Visits (SQV), Site Initiation Visits (SIV), Site Monitoring Visits (SMV), and Site Closeout Visits (SCV)
- Ensure Good Clinical Practice (GCP) compliance and accurate data verification.
- Perform routine monitoring visits, manage data queries, and ensure the integrity of trial data.
- Oversee the execution of monitoring plans, preparing reports, and resolving site issues.
- Provide site training and support, including logistics for leukapheresis and CAR-T shipments.
- Facilitate technology support and ensure sites have access to necessary materials and information.
- Prepare and complete monitoring reports and ensure timely submission of regulatory documents.
- Manage Clinical and Investigational Medicinal Product (IMP) supplies, ensuring proper storage and accountability.
- Execute monitoring plans according to study timelines, adjusting strategies based on enrollment needs.
- Participate in site selection, start-up activities, and ensure readiness for audits.
- Up to 35% of traveling to clinical trial sites will be required.
Qualifications:
- Bachelor’s degree in a scientific or healthcare field.
- Previous experience as a Clinical Research Associate.
- Oncology and/or gene therapy site monitoring experience is beneficial.
- Familiarity with regulatory compliance and GCP guidelines.
- Proficiency in English, both written and verbal.
Preferred Qualifications:
- Ability to build and maintain professional relationships with site personnel and team members
- Skilled in analyzing data, identifying issues, and implementing solutions.
- Effective communication abilities to convey complex information clearly and liaise between site staff and the research team.
- Attention to detail, flexibility in managing multiple priorities and adapting to changing project needs.
- Comfortable using clinical trial management systems and addressing basic technology issues, with the ability to escalate more complex problems appropriately.
- Open to traveling to clinical sites as required for monitoring and training purposes.
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Seniority level
Associate -
Employment type
Full-time -
Job function
Research and Science -
Industries
Biotechnology
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See who you knowFeatured Benefits
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Medical insurance -
Dental insurance -
Vision insurance -
401(k)
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