Clinical Research Associate (CRA)

Regulatory        ·          Salt Lake City, Utah, United States       ·        Full time

Description

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 – we love what we do and so do our partners. We want you to as well.
• Willingness to travel – we respect and observe current safety guidelines. As/when it is safe and practical to do so, you’ll be expected to travel to visit clinical sites.

How we work:

• Act with integrity and assume good intent – We’re as proud of how we’re building as we are of what we’re building. We do the right thing, follow through, and look out for each other. If someone’s stuck, we reach out and help them grind. We’re a team.
• Give a damn – We do what we do because we’re committed to the cause – working for the next patient, the next caregiver. We listen to patients, their families, their doctors, and build to their needs. We take ownership of that responsibility, our work, and we commit to the mission.
• Debate ideas, not personalities – Everything we’ve done has been for a reason, but precedent does not equal best practice. We constantly challenge our own ideas while respecting our team’s contributions and competence.
• Exceptional changemakers – We have to be exceptional – for patients, caregivers, and ourselves. We hold ourselves and each other to the highest standard. We step up to take ownership, leadership, and we follow through. We hire specialists who do the same.
• Lean into the turn – Healthcare is in constant change. In turn, we constantly accept feedback and change with it. We’re flexible, agile, creative, and we lean into it.
• Perpetual growth – When you’re creating the next frontier in diagnostics, nobody knows everything. We’re always looking for how we and the company can learn and grow together.
• We’re serious about our work, not too serious about ourselves – We’re committed to the mission, but your life at work is not your entire life. We have families, friends, pets, hobbies. We want you to bring your whole self to the team and experience your whole self, outside of Epitel. That’s why we have regular get togethers, generous vacation, and flexible schedules. The best thing to do with your life is enjoy it.
• No cloak, no dagger – We’re an open culture. Everybody has the full picture of what’s happening within Epitel. No silos.

Benefits

• Remote-friendly – our core team is located in Salt Lake City, but we’re open to the best candidate anywhere in the US. To that end, we provide a stipend for remote work site of your choice (e.g., WeWork, Industrious) and WFH gear (e.g., keyboard, mouse, camera, etc.)
• Medical/dental coverage
• 401k contribution
• Unlimited vacation
• Equity – every employee shares in Epitel’s success.
• Professional development allowance
• Regular IRL meetings – remote work is convenient, but it’s important to get to know one another in-person. We organize time for us all to be physically in the same place every once in a while.