Clinical Research Specialist
1 tydzień temu
Clinical Research Coordinators play a vital role in supporting Investigator Site staff in conducting clinical research studies according to project-specific requirements and regulatory guidelines.
The Clinical Research Coordinator is responsible for assisting in study-related activities at the site level, ensuring compliance with protocols, Standard Operational Procedures (SOPs), and international and local clinical trial regulations (ICH GCP Guidelines, CFR, GDPR, HIPAA, etc.).
Key Responsibilities:- Support organization and execution of monitoring visits and audits at the Investigator Site, including arranging visits, preparing documentation, and coordinating with relevant site personnel.
- Enter patient-specific data into applicable clinical systems (eCRF, ASM, etc.) and assist in resolving data queries.
- Arrange and coordinate patient visits and communication.
- Maintain assigned sections of the Investigator Site File and patient documentation.
- Participate in internal meetings and teleconferences.
Requirements:
- Bachelor's degree in a relevant field such as business administration, project management, or a related discipline.
- Experience in a similar role or environment, with a focus on oncology project support.
- Strong analytical skills and attention to detail, with the ability to work effectively in a team.
- Excellent communication and interpersonal skills, with a collaborative approach to problem-solving.
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