Clinical Research Associate

Remote/San Francisco /
Clinical Development & Operations /
Full Time
/ Remote
Loyal is hiring a Clinical Research Associate. The clinical operations team is a critical part of our path to accomplishing Loyal’s North Stars. We are seeking a seasoned veterinary professional that also has a professional history with clinical trials. You’ll join the Veterinary Operations team that achieves their mission through maintaining veterinary relationships, connecting with the veterinary community through education, ensuring excellence in the science behind our products, executing clinical trials and studies, and ensuring all related activities are in alignment with other Loyal departments.

You will be responsible for trial management and coordination, tracking of essential study documentation, and building relationships with veterinary clinics who are interested in collaborating with Loyal. You would report to our Clinical Operations Department, and will work closely with Loyal’s Computational Biology, Regulatory, and Clinical Development teams.

While you will be ultimately responsible for coordinating clinical research, you will have ample opportunity to work with, learn from, and influence other functions in the company.

Job Description - Duties of Role

    • Being the face of the company with the clinic and 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).
    • Managing clinical study sites from qualification to close-out visits.
    • Developing and maintaining necessary documentation (e.g., Standard Operating Procedures (SOPs) and Work Instructions (WINs)) and tracking including but not limited to communication records, visit reports, study tools and forms, and performance and reference tracking.
    • Providing ongoing and robust training and support for study site investigators and staff.
    • Supporting audit readiness and follow-up.
    • Providing exceptional support with site and subject recruitment strategies in alignment with regulatory guidance.
    • Ensuring compliance with FDA CVM, VICH-GCP, and study protocols.
    • Performing study data monitoring in accordance with Good Clinical Practice (GCP) and ALCOA standards.
    • Reviewing, reconciling, and ensuring appropriate record keeping for the site and investigator binders and the Trial Master File (TMF).
    • Developing a study site database to use for current and future clinical study recruitment, in collaboration with the Veterinary Ambassador.
    • Partnering with the Clinical Operations Team to facilitate investigational product supply and management at the study and site level.
    • Supporting the Clinical Operations Team in development and maintenance of metrics reporting as well as working on cross-functional collaborative activities where requested.
    • Supporting the Clinical Operations Team in facilitating vendor support related to site study services and supplies (ex. Electronic Data Capture (eDC) assistance, specialty supply and resupply).
    • Working with the Clinical Operations Team and other Loyal staff to develop company clinical trial processes.
    • Appropriate and accurate use of eDC and other auditable trial documentation systems. Inclusive of timely submission of enhancement requests or bug fixes to facilitate continuous improvement.
    • The CRA serves as the primary contact between the sponsor and the study sites, investigators and other study personnel.
    • Performing User Acceptance Tests of eDC systems (it is ideal to have a monitor to test the eDC prior to giving access to site).
    • Identifying and participation in the selection study sites, investigators and laboratories in use in clinical studies.
    • Conducting site visits as needed such as pre-selection visits, initiation visits, monitoring visits and close out visits.
    • Working in collaboration with data management, statisticians, regulatory affairs and quality assurance.
    • Assisting in preparation of study files for submission to regulatory agencies.
    • Learning and utilizing systems (e.g., project management, relationship management, etc.) as needed.
    • Maintaining excellent levels of attention to detail in all aspects of record keeping.
    • Taking courses or earning certifications as deemed necessary to perform in the role.
    • Attendance and representation of Loyal at conference events (e.g., In the Loyal booth).
    • Other duties as assigned.

Work Experience and Education

    • Required - Bachelor’s degree in a related field or equivalent combination of education, training and experience.
    • Required - Excellent and demonstrable communication, presentation and interpersonal skills.
    • Required - Extraordinary attention to detail, with work history supporting the need for detailed veterinary specific record keeping.
    • Required - Depth of understanding for the general practice veterinary environment (patient flow, visit types, PMS systems, and hospital staffing).
    • Preferred - Experience working within VICH GCP Guidelines.
    • Preferred - Experience in Clinical Research and /or product development in the animal health industry.
    • Preferred - CRA or similar clinical certification.
    • Preferred - CVT/LVT/RVT/CVPM type certification(s).

How you work and think

    • You are flexible, open-minded, and have a positive mindset toward working in the fast-paced and rapidly evolving start-up environment.
    • You are able to give and receive feedback constructively, you encourage your team during challenges, and celebrate wins whenever possible.
    • You meet or beat rapid deadlines and you work well under pressure.
    • You have exceptional integrity as well as excellent attention to detail and personal organization.
    • You are detail oriented, responsive, and enjoy high-responsibility environments.
    • You have a high degree of compassion, curiosity, and personal drive.
    • You love the veterinary industry, and the professionals that choose vetmed as their calling.
    • You are eager to learn and grow your skills.
    • You love science, and want to engage fully in the science Loyal is pursuing.
    • You are approachable, and engaging.
    • You work well, and travel well, autonomously.
    • You love to travel for work.
    • You plan ahead.

What you might not like about the role?

    • Loyal is a startup in early adolescence and is experiencing the requisite growing pains.
    • Travel will be a part of your role as a CRA. The amount of travel will vary, and will required flexibility and adapting to the need at hand during trials.
    • You will be pulled in different directions and being asked to do things outside your normal scope.
    • Veterinary Operations has a lot of moving parts. As a part of the team, you would need to be ready for change as the company grows and the team evolves.
    • To appropriately support our sites, you will need to be available during the site’s operational hours/days, some of which will fall on observed Loyal holidays.

Why join us?

    • Full-time position with flexible remote and hybrid work opportunities
    • Full coverage platinum health insurance (medical, dental and vision) for you and your dependents
    • 401k
    • Generous monthly stipend package for wellness, learning, and fitness
    • Stipend for home office set-up
    • Flexible paid time off & 28 days of whole company holiday per year
    • Paw-ternity leave for pet adoption
    • Dog-friendly office
    • Generous relocation package
    • Welcome kits with Loyal swag
    • Our cash compensation amount for this role is targeted at $68,000 - $105,000/yr. Final offer amounts are determined by candidate experience, expertise, and geographic location and may vary slightly from the above mentioned amounts.
Our Values

Lean into moonshots | We do not 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.
 
Transparency and rejecting paternalism | 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. Empower team 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.