Clinical Research Associate (CRA)

About Epitel: Epitel is a venture-backed company empowering clinicians, patients, and caregivers who live with or care for neurological disorders. Epitel employs proprietary EEG wearables and powerful AI to create a new platform for neuro-diagnostics. We’re building toward a continuous neurology care platform that will create novel biomarkers for neurological disorders. If you’re interested in a high-impact role at a neurology pioneer, this is it!

Role mission: You will be one of the first hires in Epitel’s expanding Clinical Affairs team. We’re looking for an experienced and customer-focused Field CRA to be the key point of contact for our clinical partners, build trial processes, execute, and close out clinical trials. You’ll work directly with the leadership team to execute on near-term goals while playing a role in shaping future processes. Beyond near-term goals, our new Field CRA will have a significant opportunity to define the scope of her/his role. All remote candidates within the continental US will be considered.

In short, you will ensure all new and upcoming clinical partners have smooth onboarding experience, work with the development team to troubleshoot partner issues with courtesy and speed, ensure data from all clinical relationships is extracted in a usable manner, and own on-site client training.

The role:

• Develop and implement trial master file processes and procedures.
• Develop project-specific documents, protocols, informed consents, monitoring plans, study budgets, and other study-related documents.
• Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits including an ongoing site file review. Performs validation of source documentation as required by sponsor.
• Develop and implement standard training and onboarding for new clinical sites.
• Oversee the setup of the trial sites; ensure each site has the appropriate trial materials, train site personnel on protocol and study procedures.
• Manage ongoing clinical trials from multiple epilepsy centers across the U.S as part of grants, ensuring that they are enrolling patients, analyzing their data, and providing data and files to Epitel in the timelines expected.
• Organize data in systematic manner to allow for efficient and accurate clinical reports, including developing marketing registry to aggregate data from clinical pilots for use in papers and marketing collateral
• Be first point of contact for clinical partners. Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols. Interface with medical, clinical, regulatory, procurement and administrative staff as necessary to accomplish responsibilities.
• Bring experience and suggestions regarding creation and management of maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and SharePoint).
• Assist in writing/revising clinical portions of Regulatory submissions as required.

Who we're looking for:

• Customer success mentality - you will be working hand-in-hand with our clinical partners to ensure their success.
• Clinical research experience - Certified as a CRA (E.g., CCRA, CCRP, or other CRA certification) is preferred. At a minimum, you should have
  • Clinical research experience in MedTech, biomedical or CRO industry,
  • Working knowledge of FDA, ICH, and GCP governing the conduct of clinical trials, and
  • experience with Institutional Review Board (IRB) preparations and submission, and
  • Experience with managing studies in electronic data capture systems.
  • Start-up experience - experience working at early-stage startup or similar high growth environment
• Entrepreneurial - we’re a small team. That requires everybody to take initiative and ownership for their role, manage multiple deadlines and priorities, and flex between independent and collaborative work as necessary.
• Efficient - speed and agility are some of our competitive advantages. We expect you to move fast with quality output.
• Confidence in communication - your role will be heavily customer-facing. As such, you should be confident interacting primarily with external institutions at all levels of the organization. You should have excellent communication skills to do just that and the ability to quickly build relationships and influence without authority.
• Honest and trustworthy - we’re nothing without trust. Clinicians, patients, and caregivers must be able to trust Epitel as an organization and you as an individual.
• Enthusiasm -