Who We Are
Ashvattha Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel hydroxyl dendrimer (HD) therapeutics (HDTs) to treat unmet medical needs in oncology, ophthalmology, and inflammatory diseases. We believe that HDTs will become the future of targeted therapeutics and unlock new levels of patient care.
The successful candidate will be responsible for supporting the execution of Ashvattha's clinical trials. They will work closely with the study team to oversee the day to day activities of studies in accordance with applicable SOPs, policies and national/international regulatory guidelines. The CRA/Sr. CRA will work closely with CTM/Sr. CTM and vendors to ensure successful execution and delivery of assigned clinical trials are within scope, budget and timelines. The CRA/Sr.CRA will work closely with the cross-functional team and thrive in a fast-paced environment focused on results but individual development. This role will work closely with the VP and other team members within Clinical Operations in the development of RFPs, feasibility assessments, selection and management of vendors. The is a critical role that will be responsible for supporting study activities, such as review and input into study plans and manuals, ICF review and approval, monitoring plans, monitoring visit report review, attending monitoring visits (not mandatory), site regulatory packets review and approval, oversight of site and CRO activities and training, TMF oversight, data entry and query resolution.
The key goals for this role are to support the execution of Ashvattha's clinical programs. Specifically, to support the achievement of the 2022 Corporate goals for each study, through ensuring the 1. oversight of critical vendors, 2. support enrollment activities by working closely with CRO on strategies to maximize enrollment and mitigate study risks and 3. collaborate with internal team in the development of processes and policies to support the execution of clinical trials at Ashvattha.
Experience and Skills
B.S. Degree in a related discipline. Proven expertise in managing complex studies and enrollment activities, building positive work relationships internally and externally, knowledge of FDA/EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
Must be able to work on site at the Redwood City office 2-3 days per week.