JOB TITLE:  Senior Clinical Trial Specialist
DEPARTMENT:  Clinical Operations
HIRING MANAGER:  Lorna Dean
LOCATION:  South San Francisco, California / Remote (Hybrid)
TYPE:  Full-Time

HI-Bio is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. We have a precision medicine approach grounded in emerging human genetics. HI-Bio's team is made up of industry experts from science and technology. We are on a path to building the leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.

We are seeking a Senior Clinical Trial Specialist to assist in the execution of Clinical Trials. The successful candidate will be able to support the conduct of clinical trials with minimal guidance/supervision while ensuring alignment with GCP and HI-Bio’s SOPs. The Specialist provides a high level of administration, coordination and organizational support to the Clinical Study Lead and team members from all functions involved in assigned study(ies). The role requires an ability to manage multiple priorities consecutively and priorities consecutively and sequentially and meeting quality standards for accuracy, attention to detail and timelines. As part of a growing clinical development operations team, the Specialist will help define various aspects of clinical trials to ensure timely completion, efficient protocols, budget alignment, and compliance with ICH/GCP Guidelines.

The role reports to the Senior Vice President, Development operations. Level will be commensurate with experience.

KEY RESPONSIBILITIES:

• Overall global tracking of study deliverables with escalation of key issues/trends.
• Support and/or manage protocol related site/supplier activities.
• Assist and/or manage in the design, format, review and content of study guides, worksheets, quick reference cards and other materials/documents used to support the study.
• Contribute to protocol review and amendment management, including informed consent initiation and updates.
• Attend, contribute and potentially lead supplier meetings; work with suppliers to resolve issues, and foster process improvements.
• Monitor progress of studies, help identify study related trends/issues and work with Clinical Trial Managers (CTM) to implement corrective actions when necessary.
• Submission of documents to TMF and assist with TMF reconciliation as needed.
• Oversee study start-up activity tracking with CTM oversight.
• Assist with maintaining FAQ and ADI logs; manage resolution of actions.
• May assist with the quality control of clinical data for CSR preparation.
• Assist CTM with meeting agenda and maintain minutes for internal /external team meetings.
• Assist tracking study milestones in tools and dashboards.
• Point of contact (as delegated) for study related issues.
• May participate in data review (e.g., line listings).
• Contribute to the development of recruitment strategies and materials; assist with external recruitment activities and supplier management.
• Work with sample management to coordinate shipment and analysis of sample needs; lead reconciliation efforts.
• Track study level investigational product accountability and reconciliation for studies and at close-out with depots; align with CMC to determine supply needs.
• Manage temperature excursion process flow.
• Help coordinate investigator meetings, study related workshops, and other meetings as applicable.
• May provide clinical site support (e.g., materials to site/CRAs).
• Support and contribute to Inspection Readiness processes.
• May participate in cross-functional study management activities and process improvement initiatives.
• Postings to clinical trial websites.
• Lead Site Management Oversight tasks to ensure CRO activities are being completed per the Monitoring Plan.
• May conduct monitoring/co-monitoring visits with CRO or CTM.
• Participate in User Acceptance Testing (UAT) with supplier systems.
• Contribute to protocol review, content and ICF development.
• Overall collaboration with process development and implementation.
• Some travel may be required (<30%).

EDUCATION AND QUALIFICATIONS:

• Combination of degree and relevant Biopharma related experience within a pharmaceutical, biotech environment or other relevant experience.
  • Bachelor’s degree and 3 years of direct related experience
    or
  • Associates degree and 5 years of direct related experience
    or
  • High school diploma or equivalent and 6 years of direct related experience
    and
  • 3 years direct experience in a Clinical Operations related function/role
• Ability to manage multiple priorities and allocate tasks efficiently to keep trials on track
• Experience in a small company or immunology is a plus
• Current knowledge of ICH, GCP, and other regulatory guidelines
• Ability to think critically and solve problems, possesses a quick and analytical mind, is a fast‑learner and works well in an organization that places a high value on intellectual capacity
• Strong attention to detail and an ability to identify gaps and innovate solutions
• Excellent written and verbal communication and a highly motivated disposition 

HI-BIO RECRUITING:

HI-Bio, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.