Clinical Trial Lead/Clinical Research Associate

Who We Are

Vial is a global tech-driven CRO providing next-generation Clinical Trial management services. The Vial CRO powers its drug discovery arm, Battery Bio, an AI-powered hyper scalable biotech. Battery Bio harnesses Vial's unique 90% lower cost structure to produce more affordable drug development with efficient, streamlined Clinical Trials.

Our mission is to reimagine the drug discovery process to empower scientists to cure all human disease. We have assembled a talented team of clinical operators, chemists, and innovative thinkers to achieve this vision.

Vial is a San Francisco, California-based company founded by Simon Burns in October 2020. Since our founding, we have become a fast-growing company of 100+ employees with over $100 million in funding from esteemed investors including General Catalyst, Box Group, and Byers Capital.

Vial is rebuilding the infrastructure to advance research. By deploying technology at every step, we are creating a more efficient future for drug discovery.

Here at Vial, we move incredibly fast and we will look to you to build a culture emphasizes our values and commitment to excellence. Working with the team, you’ll will develop and lead our workforce strategy, building out our policies and programs as the company scales. You'll provide guidance and counsel and have the opportunity to improve and impact every employee's experience.

Job Overview

We're seeking a Clinical Research Associate/Clinical Trial Lead to join our team, reporting to the Director of Clinical Operations. As a Clinical Research Associate, you'll oversee site management and monitoring across our organization, collaborating closely with sponsors in various therapeutic areas. Additionally, as a Clinical Trial Lead, you'll provide expert guidance to clients and team members, ensuring best practices are tailored to each project and patient population.

What you'll do

• Managing clinical operations deliverables, ensuring adherence to timelines, quality standards, scope, and financial parameters.

• Collaborating closely with the Project Manager to develop comprehensive plans, monitor resource allocation, and ensure efficient delivery of clinical site management and monitoring in accordance with contractual obligations.

• Proactively identifying risks and promptly escalating them to the Project Manager and relevant functional leads.

• Ensuring transparent communication internally and externally regarding study progress and issues, in coordination with the Project Manager.

• Developing and maintaining project-specific clinical operations plans, including Clinical Monitoring Plans, Cohort Management Plans, and Recruitment Plans, as required per project.

• Creating and managing project-specific clinical operations reference materials and tools, including study-specific forms and logs.

• Developing training materials and conducting training sessions for the clinical operations team throughout the project lifecycle.

• Providing operational oversight for site and Clinical Research Associate (CRA) deliverables, monitoring key performance indicators such as site activation, subject recruitment, monitoring visits, data quality, and currency.

• Managing CRA resourcing, site assignments, visit schedules, and serving as the initial point of contact for clinical operations and monitoring issues.

• Reviewing and approving site monitoring visit reports, while monitoring and tracking related metrics for compliance with the Clinical Monitoring Plan and Standard Operating Procedures (SOPs).

• Conducting monitoring visits, co-monitoring visits, assessment visits, and team training sessions as necessary.

• Overseeing site management and monitoring activities across all US clinics, adapting, driving, and tracking subject recruitment plans in collaboration with sites.

• Providing protocol and study training to assigned sites, creating and maintaining monitoring visit reports and action plans.

• Eventually engaging in co-monitoring, training, and mentoring junior team members.

• Being willing and able to travel within the US as required.

What you'll bring

• Minimum of 5 years of relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience.

• Minimum of three (3) years' experience as a Clinical Trial Lead or equivalent (Clinical Trial/Study Manager) or relevant clinical operations experience at a CRO, biotech, or pharma company.

• Minimum of 2 years of experience as a Clinical Research Associate.

• In-depth knowledge of Clinical Trials; the ability to see the bigger picture and prioritize critical elements of success.

• Early phase Clinical Trial experience.

• Life science degree education with independent on-site monitoring experience.

• Experience in handling multiple protocols and sites across a variety of indications.

• Flexibility and ability to travel are paramount, with strong communication, written, and presentation skills.

• Must have experience in Dermatology and Ophthalmology studies.

$90,000 - $95,000 a year