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Lead Clinical Research Coordinator

Full Time

curebase

 

About the role

Curebase is seeking a Lead Clinical Research Coordinator who will thrive in a quickly scaling clinical trial technology environment. The clinical operations team at Curebase is deeply collaborative, and you will work with nearly every function at the company. Unlike most clinical research roles, this is an entirely remote position. You will conduct activities within the clinical operations department, with a particular focus on remote activities requiring direct patient engagement (e.g., obtaining consent), data entry, and query. You will get to apply the Curebase decentralized clinical trial platform to run virtual clinical trials and help move clinical research forward. Reports to the Site Operations Manager 

What you’ll do

  • Perform duties for assigned clinical study(ies) as delegated by the Principal Investigator and as assigned by the Site Operations Manager
  • Conduct study activities (e.g., conducting the consent process and the recording and management of study data, virtual visits, randomization, follow up)
  • Interact with study subjects via multiple remote venues (e.g., phone, email, text, chat) 
  • Function as subjects’ primary point of contact and facilitate the involvement of other study team members, as needed (e.g., notify Principal Investigator of safety events
  • Manage subject visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)
  • Solicit and record information regarding safety events and prepare safety event documentation for review by the Principal Investigator
  • Request, obtain and review subjects’ medical records
  • Transcribe information from source documents (e.g., medical records) into the EDC
  • Maintain regular contact with the Principal Investigator and site team to review the study details (e.g., progress, adverse events, enrollment)
  • Facilitate shipment of study supplies to subjects and issue appropriate study stipends
  • Remain available for meetings with the study monitors, auditors, and investigators
  • Ensure timely response to queries and documentation of study-related issues   
  • Supervise other coordinators for assigned clinical study(ies)
  • Answer team members’ questions, assist with issues and oversee work for quality and compliance
  • Develop strategies, processes, and organizational tools for clinical studies
  • Conduct team meetings to provide updates on best practices and expectations
  • Hire, train, and mentor research coordinators 

About you

  • High school degree or equivalent required. Bachelor’s degree in biology, clinical research, nursing, or related field preferred.
  • Minimum of two years experience in a clinical research environment, including a minimum of one year working across multiple protocols
  • Must be qualified by education, training, and experience to perform any tasks delegated to him/her by the Principal Investigator
  • Tech-savvy with the skills and ability to apply new systems to her/his everyday tasks
  • Understand the importance of adaptability and eagerness to learn and adapt to technology changes over time
  • Recent (within the last three years) training in good clinical practice
  • Working knowledge of ICH-GCP, US CFR, and HIPAA regulations
  • Leadership and organizational abilities
  • Strategic thinking and problem-solving aptitude
  • Exceptional team management skills
  • Excellent verbal and written communication and the ability to delegate effectively 

Major pluses

  • Start-up experience
  • Quality certification from a recognized institution.
  • Fluent in English and Spanish

About Curebase

Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Our vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools Curebase has designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or in other places in their community.  

This starts with Curebase’s leading decentralized clinical trial software platform which is an all-in-one, purpose-built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. Curebase also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients were convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, Curebase is the pioneer of the “BYOP” or Bring Your Own Physician model, allowing patients to use their own doctors to participate in clinical trials. 

We are reinventing a $45B market, enabling drug and device companies to increase the volume, quality, and speed of data collection regardless of patients’ physical location. COVID-19 tailwinds have created a massive demand for telemedicine and home-based trials, with two new FDA guidance letters and industry-wide adoption of remote research that will only accelerate in the years to come. You can learn more about Curebase and our next stage of growth in Crunchbase, Fierce Biotech, and MedCity News!

Benefits

  • 100% coverage for Medical / Dental / Vision
  • 401k plan
  • Flexible PTO
  • A passionate team dedicated to making a positive impact
  • Unlimited career growth opportunity
  • 100% remote work

 

Let us apply for you (from 10$)

To apply for this job please visit web.curebase.com.