Chinook Therapeutics Job Description : Clinical Trial Manager
Chinook Therapeutics is a biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways. The development focus is on rare, serious disorders with clear unmet medical needs and defined and rapid clinical development opportunities. Our lead program, atrasentan, is a late-stage clinical program for the treatment of primary glomerular kidney diseases planned to move into a phase 3 trial for IgA nephropathy by early 2021. We are also advancing CHK-336 towards a planned IND in 2021 for an ultra-orphan kidney disease. In addition, our pipeline has several other internal programs at the validation and lead optimization stages and we are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.
Chinook raised a $65 million Series A financing in 2019 from leading healthcare investors Versant Venture, Apple Tree Partners and Samsara Biocapital, and recently announced a proposed merger with Aduro Biotech, Inc., which we expect to close in 2020. Chinook will be the surviving company following the merger and will trade on Nasdaq.
Chinook currently has approximately 45 employees and is based in Seattle, Washington and Vancouver, British Columbia.
The Clinical Trial Manager (CTM) is a key member of the Clinical Operations Team, supporting the successful execution of clinical trials. The CTM has primary responsibility for implementing studies across clinical trial sites and quality oversight of site management and monitoring activities across both early and late stage clinical trials. This position reports to the Director of Clinical Trial Management.
• Support clinical trial management efforts on global, late-stage clinical trials and/or serve as lead CTM on early phase clinical trials.
• Partner with investigative site personnel, CROs, and other study vendors to drive key study activities.
• Ensure conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.
• Lead the identification, evaluation, selection, and oversight of clinical trial sites.
• Contribute to the design and review of clinical trial protocols, CRFs, and Clinical Study Reports in collaboration with cross-functional study team members.
• Develop informed consent forms and other patient-facing materials.
• Contribute to the development and maintenance of study plans and documents, including but not limited to Study Start-up Plans, Clinical Monitoring Plans, Site Instructions, Forms, and Binders.
• Contribute to development of study timelines and milestone setting.
• Contribute to study forecasting and tracking of enrollment, investigational drug, and financials.
• Perform data cleaning activities.
• Oversee relevant CRO and/or vendor activities.
• Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.
• Facilitate information flow between clinical trial sites, study team members, CRO’s, and vendors.
• Ensure completeness of Trial Master File (TMF) and various tracking systems for assigned studies.
• Participate in the preparation and follow-up of internal process audits, vendor and study site quality audits, as well as regulatory authority inspections.
• May train and mentor new clinical staff and may contribute to dotted-line management of team members.
Education, Experience, and Skills:
• 8 years of relevant clinical trial management experience
• BA/BS or equivalent
• Experience managing and overseeing CROs is strongly preferred
• Ability and willingness to travel is required (domestic and internationally)
• Thorough knowledge and understanding of CFR and GCP/ICH requirements, as well as European Clinical Trial Directive is required
• Strong leadership, communication, and organization skills
• Exceptional ability to plan, organize and conduct clinical studies with minimum oversight
• Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)
• Consideration given to candidates with therapeutic experience in kidney disease
Chinook is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.
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