Responsibilities and Duties
Essential Duties & Responsibilities:
- Primary contact for the site, supervise and monitor clinical trials to ensure adherence to ICH-GCP standards, study protocol, SOPs and regulations.
- Ensure proper adherence to protocol, Informed consent procedures, source data verification, compliance to safety reporting procedures and verify CRF entries.
- Perform routine site monitoring, remote monitoring activities, and close out visits as required.
- Ensure adequacy of drug shipment and drug accountability (and storage times and conditions are acceptable and compliance with study protocol and plans).
- Periodically reviews adverse events reported in the study and works on reconciliation of safety information.
- Oversees the medical monitor review of assigned medical review data listings to identify trends and discrepancies. Track and ensure that SUSARs (Suspected unexpected serious adverse reaction) are reported in accordance with IEC & regulatory requirements.
- Responsible for reviewing and uploading regulatory documents into the eTMF.
- Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management team.
- Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
- Is responsible for the quality, compliance and completeness of site related performance and documentation.
- Develop and maintain effective working relationships with clinical sites and ensure communication of project goals and critical requirements.
- Provide support to the project manager with ad-hoc task as required (including maintainenance of project tracking system of subject and site information).
Qualifications and Skills
- Ability to work Independently with minimal supervision
- Able to provide timely and proactive response
- Detail oriented and meticulous
- Good documentation and record keeping skills
- Excellent organization and time management skills
Experience and Education Required:
- Bachelors level degree in life sciences, pharmacy, nursing or RN preferred.
- 5 years clinical monitoring experience.
- Oncology experience is highly recommended.
- Recent experience in risk-based monitoring is desired but not mandatory.
- In-depth knowledge of Good Clinical Practice/ICH guidelines.
- Position requires approximately 10% travel (50% during peak times).
- Knowledge of the principles and practices of basic computer applications used in general office settings, including word processing, spreadsheet, database management, and presentation software and internet search engines.
- Basic math and standard English grammar and usage.
Job Types: Part-time, Contract
- Oncology: 1 year (Preferred)
- Clinical Monitoring: 5 years (Required)
- South San Francisco, CA 94080 (Preferred)
Email cover letter and resume to email@example.com.