Contract, Clinical Trial Associate, Clinical Operations
Location: San Francisco, CA
Blade Therapeutics is a private biopharmaceutical company founded on a commitment to revolutionize the treatment of debilitating, incurable fibrotic diseases that impact millions of people worldwide. The Company is an expert in novel biological pathways – including autotaxin / lysophosphatidic acid (LPA) and calpain biology – that are foundational to cell and tissue damage responses leading to fibrosis. Blade is advancing a robust pipeline of potential first-in-class investigational therapies for diseases of lung, liver and heart fibrosis, as well as neurodegenerative diseases.
Blade is advancing a robust pipeline of potential first-in-class investigational small-molecule therapies to combat diseases of lung, liver and heart fibrosis, as well as neuro-degenerative conditions. This pipeline includes multiple direct inhibitors of autotaxin / LPA and of dimeric calpains that offer distinct but complementary anti-fibrotic mechanisms.
The Company has assembled critical leadership expertise supplemented by a world-class network of scientific, pharmaceutical and clinical advisors to enable efficient and successful drug development. Since the company’s founding in 2015, Blade has used a combination of in-house drug research and selective in-licensing to build a risk-diversified pipeline. Our focused approach offers tremendous opportunity to produce disease-modifying, life-saving therapies.
Role: Contract, Clinical Trial Associate, Clinical Operations
The Contract Clinical Trial Associate (CTA) will work within the Clinical Operations Team to implement and maintain clinical trials in phases I-IV, as applicable. The CTA will be responsible for adhering to all Blade and/or vendor Standard Operating Procedures (SOPs), in addition to ICH GCP and any applicable, regional/global regulatory authority procedures. This is contract to permanent role, based out of South San Francisco, CA. The CTA will have the benefit of working with a tight-knit team to drive projects and meet deliverables. In addition to working within the Clinical Operations team, the CTA will also be responsible for some cross-functional interaction.
- Collaborate cross-functionally to support all aspects of a clinical study.
- Assist in the development, review, and formatting of study-specific documents, including plans, informed consent forms, CRFs, patient documents, protocols, reference documents, and study tools.
- Assist with reviewing and tracking of study financials, including budgets, invoicing, and payments for all vendors and sites.
- Contribute to day-to-day tracking of operational deliverables, including trial progress, site progress, and participant progress. This may include providing status update reports.
- Maintain all files and TMF and support TMF review, which may include infrequent travel to off-site locations.
- Maintain and quality audit to assure the most recent versions of documents are in the TMF.
- Assist project team with preparation and shipment of clinical trial documentation, including Investigator Site File
- Creation and distribution of meeting agendas and minutes.
- Assist in company SOP review and formatting.
- Creation and management of calendar invitations, guest list management, and note taking.
- Maintain current participating site and personnel information.
- Travel 0% - 20%.
Desired Professional Experience
- Experience with clinical databases and document repositories.
- Experience with word processing, data tracking, and vendor portals.
- Comfortable working independently with minimal supervision or guidance.
- Strong attention to detail and highly organized.
- Possess solid time management and prioritization skills.
- Experience in phase I-III trials, including global experience.
- Excellent communication skills, both oral and written.
- Proficiency in MS Word, Excel, PowerPoint, and Outlook.
- Flexible and able to adapt to changing priorities quickly.
- Ability to identify risks and communicate them to the team clearly and efficiently.
- 1-2 years of experience in clinical research or equal combination of education and experience.
- BA/BS degree, preferably in the life sciences or related field.
Interested applicants, please send resume to: Marianne Eid
Blade Therapeutics Is An Equal Opportunity Employer