Senior Oncology Research Associate
Há 2 dias
Responsibilities:
- Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits, in accordance with contracted scope of work and Good Clinical Practice.
- Adapt, drive, and track subject recruitment plans to enhance predictability and manage ongoing project expectations and issues.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites.
- Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.
- Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Bachelor's Degree in scientific discipline or health care preferred.
- At least 2 years of on-site monitoring experience in oncology.
- Equivalent combination of education, training, and experience may be accepted in lieu of degree.
- Good knowledge of and skill in applying applicable clinical research regulatory requirements.
Working Requirements:
- Degree level: Bachelor's Degree in scientific discipline or health care preferred.
- Years of experience: At least 2 years of on-site monitoring experience in oncology.
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