Clinical Trial Associate, Clinical Operations
Location: San Francisco, CA
Blade Therapeutics (“Blade”) is advancing novel anti-fibrotic therapies to meet important patient needs in an area that has seen little innovation to date. Several rare/orphan and chronic debilitating conditions manifest as a consequence of fibrosis, a complex, pathologic process in which progressive scarring replaces functional tissue. We are seeking to develop therapies to modify disease progression, and in some cases, potentially reverse the fibrotic damage to tissue.
Blade is advancing a risk-diversified product portfolio to address various fibrotic diseases and their underlying pathophysiology. Blade has assembled a critical mass of fibrosis expertise and a top-tier leadership team and world-class network of advisors with unparalleled experience in anti-fibrotic drug R&D. Blade’s founding programs are based on the discoveries of Hal Dietz, M.D., Victor A. McKusick Professor of Genetics and Medicine, Johns Hopkins University, whose pioneering research has elucidated a biological pathway that is enabling the discovery of small molecules to treat and potentially reverse fibrosis.
Blade’s objective is to be the leading anti-fibrotic company with a pipeline of novel therapies designed to address the unmet needs for innovative treatments to treat various fibrotic conditions.
Role: Clinical Trial Associate, Clinical Operations
The 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 an in-house 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.
- An attractive compensation package commensurate with experience will be provided.
Interested applicants, please send resume to: Marianne Eid
Blade Therapeutics Is An Equal Opportunity Employer