(Full-time position – US-based, with preference in Houston)
Opportunity to work at the cutting edge of drug development
Hummingbird Bioscience builds revolutionary biotherapeutics through the application of proprietary biological insights and technologies. We are on a mission to unravel the complexities of human disease. Using systems biology, we find new and elusive drug targets and engineer breakthrough biotherapeutics to precisely intercept them, giving people hope for new treatments when all others have failed. This is a bold, new way of finding the right drugs for the right people.
Hummingbird Bioscience has built a pipeline of promising drugs expected to enter clinical trials in 2021. With locations in Singapore, and Houston, Texas, Hummingbird is well funded by venture capital.
Join Hummingbird Bioscience on our journey as we transition from an early-stage drug discovery company to a global leader in drug development. We are looking for a Clinical Study Coordinator who will work closely with the Chief Medical Officer, Head of Clinical Operations, Program Managers and selected Contract Research Organizations (CRO) to help drive the development and execution of early-phase oncology clinical trials.
The Clinical Study Coordinator supports the Head of Clinical Operations by taking responsibility for areas of clinical trial delivery. The Clinical Study Coordinator works with the study team internally and externally with vendors such as CROs and other selected 3rd party vendors in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH and Hummingbird Bioscience’s Standard Operating Procedures (SOPs). Some travel to study sites may be required to assist with monitoring clinical studies.
The Clinical Study Coordinator will be assigned activities by the Chief Medical Officer and the Head of Clinical Operations, including:
- Responsibility for the day-to-day progress of clinical trials
- Assessment of risks and identification of risk mitigation strategies
- Support of feasibility assessments to select relevant investigators and sites
- Provision of oversight and input to the development of study-specific documentation including but not limited to case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc.
- Review of site-level informed consents and other patient-facing study start-up materials
- Oversight and maintenance of in-house study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF)
- Oversight of engagement, contracting and management of required vendors for the study
- Oversight input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation
- Provision of regular status reports to stakeholders as requested by the Head of Clinical Operations
- Support of data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites
- Escalation of data flow and data quality issues to Head of Clinical Operations
- Participation in UAT of eCRF build and validation documents
- Leading data reviews with the clinical team to ensure accuracy, consistency and reliability of data
- Review of database metrics and implementation of an escalation process to achieve resolution of noted issues
- Oversight of the execution of the specific clinical study deliverables against planned timelines
- Escalation of issues related to timelines or budget to the Head of Clinical Operations
- Support of accurate budget management and scope changes
- Contribution to clinical project audit and inspection readiness throughout the study lifecycle
- Support of internal and external inspection activities and contributes to CAPAs as required
- Assisting CRO in managing aspects of study closeout activities including but not limited to database lock, reconciliation of vendor contracts, study budgets, TMF and study drug accountability
- May require 15% travel
- Master’s Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, MSN, MPH, etc.).
- 5-10 years of clinical, technical/operational experience in planning, executing, reporting and publishing clinical studies within the biopharmaceutical industry; experience in clinical oncology is preferred, and experience in immuno-oncology is highly preferred.
- Successful track record in interpreting, analyzing and presenting clinical data including aggregated data analyses; understanding of oncology clinical data preferred.
- Thorough understanding of the drug development process from pre-IND through registration and post-registration required.
- Detailed knowledge of Good Clinical Practice (GCP), ICH Guidelines, including E6 (R2) and current US FDA regulations.
- Excellent interpersonal skills with the ability to build strong relationships across internal and external partners.
- Ability to work independently and with the flexibility to handle workflow in a fast-paced start-up environment.
To apply for this role, please apply on the careers page of our website with a maximum 2-page resume in PDF format, detailing your education and relevant experience, and a cover letter with your motivations for applying for this position. http://www.hummingbirdbioscience.com/en/careers/