Clinical Research Associate
Full Time | Remote , San Francisco
Send your resume and a short introduction to: firstname.lastname@example.org
Loyal is an early stage company developing drugs to help dogs live longer, healthier lives.
Loyal is hiring a Clinical Research Associate. You’ll join our newly minted Clinical Operations team to help oversee current and future clinical trials. You will report to our ClinOps Manager as well as other stakeholders across the company who will provide context for success.
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.
Loyal is founded and led by a first-gen, female CEO – we encourage and look forward to diverse applicants.
Your work may include:
Managing clinical study sites from qualification to close-out visits. Developing and maintaining necessary documentation and tracking including but not limited to communication records, visit reports, study tools and forms, and performance and reference tracking.
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.
Providing ongoing and robust training and support for study site investigators and staff. Supporting audit readiness and follow-up.
Providing exceptional support with subject recruitment strategies.
Ensuring compliance with FDA CVM, VICH-GCP, and study protocols.
Performing study data monitoring in accordance with GCP and ALCOA standards.
Reviewing, reconciling, and ensuring appropriate record keeping for the Investigator Binder and the Trial Master File (TMF)
Partnering with the Clinical Trial Manager (CTM) to facilitate and manage investigational product supply at the study and site level.
Supporting the CTM in development and maintenance of metrics reporting as well as working on cross-functional collaborative activities where requested.
Supporting the CTM in facilitating vendor support related to site study services and supplies (ex. EDC assistance, speciality supply and resupply).
Education and Work Experience
Bachelor’s degree in a related field or equivalent combination of education, training and experience
Experience working within VICH GCP Guidelines and FDA CVM regulatory requirements
Excellent communication, presentation and interpersonal skills
CRA certification a plus but not a requirement
How You Work & 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 have exceptional integrity as well as excellent attention to detail and personal organization.
You have a high degree of compassion, curiosity, and personal drive.
May be based remotely; must be able to accommodate up to 40% travel as we return to safe conditions in the post-pandemic environment
Full coverage health/dental/vision
Monthly education allowance for books and self-improvement