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Clover Health is a data driven health insurance startup driving to improve state of healthcare in US.
 
Jersey City    Posted: Thursday, March 07, 2019
 
   
 
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JOB DETAILS
 

Clover Health is launching a new initiative on diseases of aging research. Our goal is to help accelerate the development of disease-modifying therapies for the elderly patient population. We are drawing on knowledge from partners - in both biopharma & academia - to develop joint research programs.

We are looking for a Clinical Trial Lead to build & support teams responsible for execution of clinical research. Leveraging your prior experience in clinical trials, you will think about how we can apply technology to make research more patient-centric, efficient, & rewarding. You will work with our internal team & leading partners from industry, world-class academic institutions, & non-profit organizations to implement our research programs. This role is foundational to the initiative, as we believe advancing transformative medicines of the future is not possible without the close partnership of patients.

Your responsibilities will include, but not limited to, the following:

  • Assist in defining & developing clinical research strategy, study protocols, & site instructions, while representing the voice of the member/patient in the process
  • Develop & maintain training & critical clinical trial documents, such as informed consent forms (ICFs), protocols, central/specialty labs, tracking lab/imaging/clinical assessment data, & biosample management plans
  • Oversee outsourced activities to ensure CRO & vendor delivery against contracted scope of work
  • Assist with all activities related to site selection, contracting, set-up & maintenance
  • Develop & manage study-specific patient recruitment & retention strategies, ensuring the end-to-end research experience is positive & rewarding for patients, PCPs & other participants
  • Advise on the development or sourcing of software & tooling for study assessments
  • Shepherd study protocols through the Ethics & Review & IRB process
  • Provide leadership & day-to-day management of dedicated Study Coordinator team in the execution of study protocols, ensuring ongoing adherence to Good Clinical Practices (GCP's), Standard Operating Procedures (SOP's), as well as federal, state, & local guidelines
  • Serve as the interface with Clover Health member service & clinical teams as well as providers involved in the study program
  • Review/audit data collected, focusing on data integrity, trending & consistency across the program
  • Contribute to the review, analysis & interpretation of data, including the development of clinical study reports, publications & internal/external presentations


You will love this job if:

  • Are motivated by the mission of addressing large unmet patient needs in diseases of aging
  • Are committed to serving patients & creating the best possible patient experience in all research activities
  • Are passionate about the integration of clinical & research data that will advance research & care
  • Thrive in an entrepreneurial environment - comfortable & effective operating in smaller team settings


You should get in touch if:

  • 5+ years of study management experience in clinical & drug development
  • A minimum of 2 years leading a team with direct report responsibility
  • Bachelors degree or equivalent required (scientific or healthcare background preferred)
  • Working knowledge of GCP requirements & the drug development process. Experience with research protocols & regulatory groups, including HIPAA & FDA regulations & IRB requirements
  • Willingness to travel within the state of NJ & work across cultures
  • Demonstration of scientific productivity (publications, research reports, presentations, etc.)
  • Prior experience working with the elderly population a plus
  • BA/BS/BScN degree in health or biological science, or equivalent practical experience
 
 
 
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