Clinical Trial Associate, Clinical Operations
Location: South San Francisco, CA
Blade Therapeutics 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. The Company 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 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.
- Work in collaboration with the team to review line listings, write and resolve queries, review protocol deviations, and prepare for interim/final Clinical Study Reports.
- Provide support to new team members, including external vendor teams and sites. Review and format site-specific documents, including ICFs, essential documents, and site questions.
- Maintain all files and TMF and support TMF review, which may include infrequent travel to off-site locations.
- Assist in monitoring report review.
- 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.
- Drafting confidentiality agreements, consulting agreements, and master services agreements, as necessary. This will include following these to execution.
- 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.
- BA/BS degree, preferably in the life sciences or related field.
- An attractive compensation package commensurate with experience will be provided.
Blade Therapeutics Is An Equal Opportunity Employer