Clinical Operations Support (Contract position)

**Work from where you are - considering candidates in San Mateo, Santa Barbara, or US-based remote**

About Evidation

Evidation creates new ways to measure and improve health in everyday life. Built upon a foundation of user privacy and control over permissioned health data, Evidation is trusted by millions of individuals—generating data with unprecedented speed, scale, and rigor. We partner with leading healthcare companies to understand health and disease outside the clinic walls. Evidation is working to bring people individualized, proactive, and accessible healthcare—faster. Founded in 2012, Evidation is headquartered in California with employees working from around the globe.

Our Research and Insights Business Unit is looking for a Clinical Operations Support (Contractor) to join the team! Our Research and Insights (R&I) business unit delivers world-class, ground-breaking research in partnership with our customers and collaborators to better understand health in everyday life.

As a Clinical Operations Support Contractor, you will be assisting with support, monitoring and documentation related tasks for a wide range studies in Evidation’s pipeline. As a member of the team, you will collaborate with the cross functional members on the Research and Insights teams to ensure clinical studies meet or exceed high quality standards. This is a contract role based on project needs and will be remote.

• Work with Clinical Operations study team members, to support clinical study activities as defined by the clinical trial operating model.
• Support and conduct a wide range of risk-based monitoring tasks to ensure compliance with the protocol and applicable Company or Sponsor Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
• Completing relevant monitoring documentation in compliance to timelines indicated in the Monitoring Plan and/or relevant work instructions , while ensuring  internal and study-related trainings are completed per study timelines
• Develop and maintain study materials, process guides, monitoring tools and templates associated with study conduct including adverse event and Sunshine Act maintenance and reporting
• Drive risk management and mitigation initiatives including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished
• Serve as IRB liaison, prepare IRB submission packages and ensure timely continuing review and closure form submissions
• Support and manage eTMF filing, maintenance, migration/transfers and file-location mapping activities including ensuring eTMF is audit and inspection ready

• 4+ years clinical research & clinical operations experience in monitoring and/or clinical project management 
• Experience working on behalf of sponsor and/or CRO preferred
• Data management experience and excel skills preferred
• Excellent knowledge of ICH GCP guidelines and FDA regulation for clinical research
• Ability to deliver in a fast-paced, small company environment, navigate ambiguity while delivering results, and seamlessly adjust workload based upon changing priorities
• Generally tech-savvy and able to quickly learn and work efficiently across new technology platforms
• Proficient in: Google Suite; Microsoft Word, Excel, and PowerPoint
• Works well independently and with minimal direction 
• Excellent attention to detail and project management skills along with verbal and written communication skills
• Startup and digital health experience preferred University degree undergraduate required
• Willingness to learn and unlearn

*This job description outlines primary duties and requirements and is not intended to identify all tasks that may be performed; individuals occupying the position may be required to perform other duties.  The company may modify job duties from time to time, either in practice or in writing.

At Evidation, we strive to build an equitable and inclusive space where everyone - employees, partners, and participants -  belongs and feels valued. Evidation Health values diversity and is committed to equal opportunity for all persons without regard to sex (including pregnancy, childbirth or related medical conditions), gender identity, gender expression, race, color, national origin, ancestry, citizenship, age, religion, physical or mental disability, legally protected medical condition, family care status, military or veteran status, marital status, domestic partner status, sexual orientation, genetic information or any other legally protected characteristic. 

We will also reasonably accommodate the physical and/or mental disabilities of an otherwise qualified applicant with a disability in order to enable the applicant to complete the application or interview process, providing undue hardship on Evidation Health would not result. 

The US base hiring range for this contract  position is $40/hr - $47/hr +benefits through the contracting agency. The actual starting pay will be based on job-related factors, including work location, experience, training, and skill level, so pay for this role may be higher or lower than what is shown on this posting.

https://evidation.com/california-privacy-notice