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Summary:
Piper Companies is seeking a motivated Clinical Research Associate with Oncology Clinical Trials experience to work for a well-established clinical research organization and pharmaceutical company. This role requires candidates to be located in California and involves managing clinical trials, ensuring compliance with regulations, and providing communication regarding trial progress.
Responsibilities:
- Develop and maintain relationships with investigative sites and client personnel.
- Monitor sites for accuracy and validity of entries related to patient records and clinical notes.
- Provide and communicate trial status and progress reports to trial manager and client.
- Manage and maintain the data and documents required by local and ICH regulatory authorities.
- Ensure SOPs are being followed and assist with client audits and regulatory inspections.
Requirements:
- 2+ years of clinical monitoring experience required; CRO preferred.
- 1+ years of experience within the therapeutic area of Oncology.
- Experience with FDA, ICH GCP, and local regulations.
- Strong communication, interpersonal, and organizational skills necessary.
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
