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    Sr. Clinical Research Associate - San Francisco, United States - Loyal

    Loyal
    Loyal San Francisco, United States

    3 days ago

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    Description
    About Loyal

    Loyal is pioneering the development of drugs that help dogs live longer and stay healthier as they age.

    We've already achieved historic milestones on our path to gaining FDA approval for the first lifespan extension drug for any species.


    Our mission is longer, healthier lives for all, and our ultimate aim is to translate our work with dogs into the first-ever aging drugs for humans, too.

    The company was founded in early 2020 and we've raised more than $50M from top investors including Khosla, First Round Capital, Collaborative Fund, Longevity Fund, Quiet Capital, and BoxGroup.

    About the role

    Loyal is less than 12 months away from the projected launch of our first product.

    We're seeking an experienced Senior 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 close-outs) and provide overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.

    Ability to travel up to 60% of your work time.


    Develop and maintain necessary documentation and tracking including but not limited to communication records, visit reports, study tools and forms, and site performance.

    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 (TMF).

    Assist in developing 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 and the operational processes within the ClinOps team (e.g., Standard Operating Procedures (SOPs), Work Instructions (WINs), and guidance documents).

    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 (UAT) of the Electronic Data Capture (eDC) system and other clinical trial software.

    Identify and participate in the selection of study sites and vendors for clinical studies.

    Work in collaboration with data management, statisticians, regulatory affairs and quality assurance.


    Help train and mentor other CRAs on the team, ensuring quality of their data monitoring, site and documentation management, and overall organization.

    Assist with the review of site visit reports, clinical trial data, and study invoices.


    Ensure compliance with applicable regulations throughout the entire lifespan of the study (e.g., recruiting study sites and subjects; maintaining the TMF; reviewing study data; managing study drug shipments, reconciliation, and destruction; reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs); site and study close-out; data retention; etc.).

    Support study sites and other CRAs during regulatory audits.

    Assist in preparing study files for regulatory agency submission.

    Attend and represent the company at conference events (e.g., In the Loyal booth).

    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


    Love dogs :
    )


    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 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.

    What you'll gain from this role:

    Experience leading the launch of 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


    About you:
    Bachelor's degree or equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences.

    5+ years of relevant experience in the clinical trial industry.

    Excellent communication, presentation, and interpersonal skills.

    Exceptional organizational and follow-up skills, as well as attention to detail.


    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

    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.

    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.

    #J-18808-Ljbffr
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