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Clinical Research Manager
Posted on 8/9/2022
INACTIVE
Locations
Remote
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Data Analysis
Google Cloud Platform
Requirements
  • Proven track record of leading initiatives, hitting goals, and succeeding in a fast-paced team environment
  • A 'hold on and don't let go' attitude for problem-solving
  • Expert communication and interpersonal skills
  • Advanced Excel skills, Microsoft office, and GSuite skills
  • Must possess superior analytical and creative thinking skills
  • Excellent attention to detail and the ability to keep detailed, accurate records
  • Understanding of laboratory procedures and equipment
  • Advanced organizational and planning skills
  • Ability to stand for extended periods of time
  • Must be fluent in English and possess solid writing abilities
  • Willingness to travel throughout the greater LA area and be present at field operations where people that are currently or formerly infected with COVID-19 may be present (such as a testing site)
  • Bachelor's degree (B. S./B. A.) in life sciences or related field from four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience
  • Detailed knowledge of GCP/ICH guidelines and other US clinical regulatory requirements
  • Working experience with an electronic data capture system (EDC), CTMS, and eTMF system
  • High-growth or early-stage start-up experience or a demonstrable ability to operate through ambiguity
Responsibilities
  • Manage the full scope of clinical studies including, but not limited to, protocol development and implementation, site selection, site monitoring, staff training and supervision, enrollment, maintenance, study/site closeout, and data analysis and reporting
  • Prepare and review study related plans and documents including protocols, informed consent forms, recruitment plans, protocol deviation plans, case report forms, and other applicable study-related documentation
  • Develop study timelines, budgets, and outline project milestones
  • Ensure Trial Master File (TMF) is current and maintained
  • Manage cross-functional projects that involve multiple stakeholders, vendors, patients, and providers
  • Work cross functionally with various departments within Curative on all aspects of the clinical trial and serve as the liaison between internal teams and external partners
  • Improve existing operational processes and implement new procedures
  • Author/contribute to clinical study reports and manuscripts
  • Develop and implement SOPs
  • Work adhering to US regulatory and Quality System requirements (21 CFR 820, etc)
  • This position assumes and performs other duties as assigned
Desired Qualifications
  • 3+ years of experience in Clinical Research. Experience with in-vitro diagnostics is a plus
Curative

1,001-5,000 employees

COVID-19 testing & health services
Company Overview
Curative is building infrastructure to make essential health services easier to access for everyone
Benefits
  • Medical, Dental, and Vision
  • Generous Vacation/PTO
  • Stocked kitchen for in-office employees
  • 401(k) for full-time employees
  • Select remote opportunities
Company Core Values
  • Radical Ambition - Rebuilding healthcare is not for the faint of heart, but we are up to the challenge. When COVID-19 testing was few and far between, we were standing up mass testing sites around the county. Now we’re applying that same operational vision to optimize the healthcare delivery system. Every challenge is an opportunity, and every opportunity brings the potential to improve healthcare as we know it.
  • Universal Accessibility - Everyone should be able to get the care they need, when they need it. We made COVID-19 testing and vaccinations accessible through kiosks, vans, and drive-thrus to meet people where they are and build health equity. Now we’re building high-touch preventive healthcare for our communities.
  • Essential Functionality - Healthcare is filled with unnecessarily high costs and many new solutions can be more for show. Through our vertically integrated systems and data-driven decision making tools, we guide care to what’s needed and what’s preventive, while cutting out the unneeded.
  • Proven Competency - Our work is done with intentionality based on the latest science and technology. Even if it moves fast, we have the extensive research and testing behind it. Our employees come from hugely diverse backgrounds, years of experience, and fields of education. No matter where they start, we encourage employees to grow into new positions and keep developing their skills.
  • Collective Power - Healthcare doesn’t live in a vacuum. It is about where people live and work. We collaborate with diverse community partners to raise awareness and make healthcare delivery stronger.