Loyal is ~12 months away from our projected launch of our first product to market. We are seeking an experienced Clinical Research Associate to join the Veterinary Operations team that achieves its mission through developing veterinary partnerships, engaging with the veterinary community through education, ensuring excellence in the science behind our products, executing clinical trials and studies. Your work will drive us closer to our objectives of bringing the drugs to the market.

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

Your daily work will include

Be 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).
Serve as the primary point of contact for assigned study sites.
Perform clinical monitoring activities (site qualification, initiation, interim monitoring visits and closeouts) and provide overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.
Develop and maintain 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.
Provide training and support to site investigators and staff.
Provide exceptional support with site and subject recruitment strategies in alignment with regulatory guidance.
Ensure compliance with FDA CVM, VICH-GCP, and study protocols.
Review and reconcile site and Investigator binders and the Trial Master File.
Develop a study site database for recruitment purposes.
Partner with the Clinical Operations Team to facilitate investigational product supply and management at the study and site level.
Assist in creating and maintaining metric reports and participating in cross-functional collaboration as needed.
Facilitate vendor support for site study services and supplies.
Contribute to the development of 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.
Perform User Acceptance Tests of eDC systems
Identify and participate in the selection of study sites and laboratories for clinical studies.
Work in collaboration with data management, statisticians, regulatory affairs and quality assurance.
Assist in preparing study files for regulatory agency submission.
Attend and represent the company at conference events. (e.g., In the Loyal booth).

Work experience and education requirements

Bachelor’s degree or equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences.
Excellent communication, presentation, and interpersonal skills.
Exceptional organizational and follow-up skills, as well as attention to detail.

Preferred but not required:

Experience working with VICH GCP studies
Experience in clinical research and/or product development in animal health
Certifications such as CVT,LVT,RVT, or CVPM.

Reasons 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 iterated on.
We may be comfortable with more ambiguity and uncertainty than you are used to, 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.

Loyal

Clinical Research Associate

Remotefull-time$80K - $100K