Lead Clinical Research Specialist

2 weeks ago


San Francisco, California, United States Biogen Full time

Company Overview:
HI-Bio, Inc., a subsidiary of Biogen, is dedicated to advancing clinical research in the biotechnology sector. We are looking for a Clinical Research Specialist (CRS) or Senior CRS to play a pivotal role in the management and execution of clinical trials.

Position Summary:
The ideal candidate will independently support the execution of clinical trials while ensuring compliance with Good Clinical Practice (GCP) and HI-Bio's Standard Operating Procedures (SOPs). This role demands exceptional organizational skills, allowing the Specialist to provide comprehensive administrative and coordination support to the Clinical Study Lead and the multidisciplinary team involved in the assigned studies.

Key Responsibilities:
1. Oversee global tracking of study deliverables and escalate significant issues or trends.
2. Support or manage activities related to protocols at sites and with suppliers.
3. Assist in the creation, formatting, and review of study-related documents, including guides and reference materials.
4. Participate in protocol reviews and manage amendments, including informed consent processes.
5. Attend and potentially lead meetings with suppliers, addressing issues and promoting process enhancements.
6. Monitor study progress, identify trends or issues, and collaborate with Clinical Trial Managers (CTMs) to implement corrective measures as needed.
7. Manage document submissions to the Trial Master File (TMF) and assist with TMF reconciliation.
8. Track study start-up activities under CTM supervision.
9. Serve as a point of contact for study-related inquiries as delegated.
10. Contribute to recruitment strategy development and manage external recruitment activities.
11. Coordinate with sample management for shipment and analysis of samples; lead reconciliation efforts.
12. Support Inspection Readiness processes and participate in cross-functional study management activities.

Qualifications:
A combination of education and relevant experience in the biopharmaceutical field is required. Candidates should possess:
- A Bachelor's degree with a minimum of 3 years of direct experience, or
- An Associate's degree with at least 5 years of relevant experience, or
- A high school diploma with 6 years of applicable experience.

Additionally, candidates should demonstrate:
- Strong ability to manage multiple priorities effectively.
- Experience in a small company or within the immunology sector is advantageous.
- Current knowledge of ICH, GCP, and other regulatory guidelines.
- Critical thinking and problem-solving skills, with a quick and analytical mindset.
- Exceptional attention to detail and the ability to identify gaps and propose innovative solutions.
- Excellent written and verbal communication skills, coupled with a highly motivated attitude.

Work Environment:
This position is open to remote applicants within the United States.

About Us:
HI-Bio, Inc. is committed to delivering innovative therapies for patients with severe immune-mediated diseases. Our team is dedicated to transforming patient lives through groundbreaking clinical research and development.



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