You will be working bothindependently and collaboratively with our senior management team and external CROs with primary responsibility for the execution of Zenflow’s clinical research program.
Ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Zenflow’s Standard Operating Procedures.
Maintain clinical study records in compliance with ISO 14155:2011, US and EU regulatory requirements.
Identify and routinely use the most effective, cost efficient and best business practices to execute processes; continually evaluate effectiveness and appropriateness.
Site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing and trending adverse events and protocol deviations, as applicable.
Contribute to developing study related materials (monitoring plans, ICF, CRFs, etc); assists with writing reports and protocols. Drafts informed consent documents and ensures all required elements are included.
Assist with site training to protocol and GCP. Provides product/protocol specific support and training to internal and external clinical personnel.
Provide oversight of vendors and committees such as core labs and safety boards.
Participate in site screening, initiation activities; study monitoring. Review monitoring and other study reports issued by external CROs.
Oversee external CRO’s, worldwide and in the US, managing costs and tracking deliverables.
Author and maintain clinical procedures in compliance with ICH GCP and the ethical principles outlined in the World Medical Association Declaration of Helsinki.
Prepare forecasts for study enrollment and track and follow up with clinical sites and CROs as necessary.
Complete accurate study documentation (source documents/ paper worksheets where designated, patient notes, complete case report forms on eDC, accurately transcribing source information as required).
Develop for review draft Case Report Forms and associated edit logic.
Coordinate and lead activities with study specific committees, vendor services, and core labs.
Independently review site compliance and raise issues to study management. Can lead team meetings reviewing compliance concerns.
Serve as a liaison to field clinical and site personnel by responding to any protocol-related issues and escalating as appropriate.
Communicate and collaborate with all levels of employees, customers, contractors, and vendors.
Apply general clinical research processes and regulatory knowledge to actively improve processes and efficiencies.
Exercise independent judgment in planning, organizing, and performing work.
Bachelor’s Degree with 7+ years of related experience in the medical device industry with previous experience as a CRA.
Experience executing clinical trials in the medical device industry, including managing clinical site relationships, interfacing with CROs, site initiation, qualification, and training, case support, clinical documentation preparation, use of electronic data collection systems, and compliance with applicable standards.
Excellent interpersonal, teaming, written and spoken communication skills.
This position will require travel.
Zenflow is a South San Francisco-based clinical-stage medical device company developing a therapy to relieve the urinary symptoms of Benign Prostatic Hyperplasia (BPH). Founded in 2014 out of the Stanford Biodesign Program with support from Y Combinator, StartX, and the UCSF Rosenman Institute, Zenflow is developing a unique flexible, catheter-based approach to move BPH therapy to the office.