Sr. Clinical Research Associate

 

About Loyal

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. In other words, our mission is to help dogs live longer, healthier lives.

We’ve already achieved significant milestones on our path to gaining FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track to bring the first product to market in 2025.

Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.

 

About the role

Loyal is less than 12 months away from the projected launch of our first product. We’re looking for an experienced Senior Clinical Research Associate (SCRA) to join our Clinical Operations team, working in close collaboration with the Head of Clinical Operations. You will be responsible for leading and coordinating with our team of Clinical Research Associates (CRAs) to ensure smooth execution of all clinical trial activities at Loyal.

The SCRA will also represent Loyal at clinical trial sites, building trusting relationships and positive experiences for study vets, vet techs, site staff and pet owners in accordance with the Loyal Service Level Expectations (SLEs). Your work will drive us closer to our objectives of bringing our drugs to market.

You will be reporting directly to the Head of Clinical Operations.

 

Your daily work will include:

• Develop and foster strong relationships with clinical trial sites.
• As the lead CRA, train and mentor other CRAs and attend co-monitoring visits, as needed.
• Lead internal CRA team meetings and review monitoring visit reports.
• Ensure the study is inspection-ready at all times by maintaining study documentation in the appropriate systems (Electronic Data Capture (eDC) system, Electronic Trial Master File (eTMF), and/or other secure location).
• Contribute to budget planning, resource allocation, and setting study timelines.
• Participate in the selection of clinical trial sites, laboratories, Clinical Research Organizations (CROs), and other vendors.
• Develop and/or assist in the development of Standard Operating Procedures (SOPs), Work Instructions (WINs), and other Loyal process documents.
• Contribute to critical study documents (ie, study protocol, monitoring plan, etc.).
• Support the development of clinical trials systems and software, including User Acceptance Testing (UAT) of the Electronic Data Capture (eDC) system and the clinical trial management system (CTMS), as well as providing feedback on these systems to facilitate continuous improvement.
• Assist in the preparation of study files for regulatory agency submissions, as needed.
• Support and/or lead audit/inspection activities, as needed.
• Attend and represent the company at conference events (e.g., In the Loyal booth).

 

Assigned sites:

• Serve as the primary point of contact for assigned study sites, providing exceptional operational support to ensure proper execution of the trials.
• Ensure sites are conducting trials in accordance with study protocol and the principals of Good Clinical Practices (GCP), the International Cooperation on Harmonization of Technical. Requirements for Registration of Veterinary Medicinal Products (VICH-GCP), and the Food and Drug Administration Center for Veterinary Medicine (FDA CVM), as well as other applicable regulations.
• Perform clinical monitoring activities, including site qualification visits, site trainings/re-trainings, site initiation visits, interim monitoring visits, and site close-outs.
• Collect, review, and reconcile essential documents in the site and Investigator binders against the Trial Master File (TMF).
• Track and maintain individual site recruitment goals.
• Identify monitoring deficiencies in the site’s conduct of the trial, and collaborate with the site on risk mitigation and process improvement.
• Proficient in the use of electronic data capture (eDC) systems and other auditable trial documentation systems.
• Facilitate vendor services with the site, including ensuring adequate investigational product supply and management of the central laboratory.
• Support sites in preparation of regulatory audits, as needed.
• Support the head of clinical operations in review of study invoices.

 

Your background and experience:

• Bachelor’s/Master’s degree in animal/veterinary science, biology, or related life sciences.
• Minimum of 5 years in clinical trial conduct, clinical development process, and regulatory requirements.
• Excellent leadership, communication, presentation, and interpersonal skills.
• Exceptional organizational and follow-up skills, as well as attention to detail.

 

While not required, we’d be especially excited if you:

• Have experience working with VICH GCP studies
• Have experience in clinical research and/or product development in animal health
• Are certified in CVT, LVT, RVT, or CVPM

 

How you work and think:

• You are adaptable and have a positive mindset in a fast-paced startup environment.
• You are effective at giving and receiving constructive feedback.
• You thrive well under pressure and meet tight deadlines.
• You have exceptional integrity, attention to detail, and personal organization.
• You are compassionate, curious, and driven.
• You are passionate about the veterinary industry.
• You are eager to learn and grow your skills.
• You are enthusiastic about science and Loyal’s pursuits.
• You are approachable and engaging.
• You are autonomous in work and travel planning.

 

Why you might not like this role:  

• Fast-paced, rapidly scaling startup environment.
• We are still relatively new, therefore many systems are either not in place or being developed/improved.
• We may be comfortable with ambiguity and uncertainty as we like to test hypotheses early. You will have to be comfortable taking full responsibility for your area of expertise, with support and guidance from the rest of the team and company.
• You will need to be comfortable adapting to change and operating in a fast-paced, highly regulated environment.
• Building and troubleshooting processes from scratch.
• You will need to be creative in solving problems, especially those without precedent.
• Building difficult things is…difficult. The process forward is not always linear.
• We continually find ways to enhance hybrid remote working and communication.

 

What you’ll gain from this role:  

• Experience launching a first-of-its-kind drug to market.
• A working environment that is positive, kind, thoughtful, and full of some of the smartest people in the industry.
• Experience building process and doing impactful work.

 

Loyal benefits:

• Full-coverage health insurance — medical, dental and vision — for you and your dependents
• $1,000 home office equipment stipend
• $1,200/year learning budget for books, courses, etc.
• $250/month wellness budget for gym, cleaners, spa, food, etc.
• All 3-day weekends are turned into 4-day weekends 🎉
• Unlimited vacation and paid holidays
• Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
• Annual company retreat at beautiful locations across the country (recently: Tahoe, Cape Cod)
• Competitive salary
• Company equity options grant for new hires

Salary range: $100k - $120k

Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. 

 

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Our Values

Lean into moonshots

We don’t settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.

Opportunity is at the intersection

We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.

Expertise without ego

Titles do not determine who has a voice. We work on hard, technical problems and have a ton of fun while at it.

Learning by doing

Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.

Lead with context

We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.

Empathy and respect for all life

Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.