• Posted on: Jun 16, 2022
  • Location:
  • Job ID: a6b4774a
  • Type: Full Time
  • Posted on: Jun 16, 2022
  • Location:
  • Job ID: a6b4774a
  • Type: Full Time

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My client, a commercial-stage, publicly traded, medical device company developing products to help patients with venous diseases, is hiring a remote Northern New England-based Regional Clinical Research Associate (CRA)/Site Manager to conduct site monitoring visits and site management activities on Vascular Medical Device studies utilizing good clinical practice (GCP) and all applicable regulations. 

 

This permanent, Regional CRA is responsible for monitoring and site management of the Northern New England Regional clinical sites including the Boston, MA area, Rhode Island, Upstate New York, and New England.  This is a home office-based CRA position with an average of 50% travel to regional sites.

 

Site locations: New England Region (Boston, RI, Upstate NY, New England)

 

Responsibilities

  1. Perform all aspects of site selection, site management, and site monitoring from start to closure of a clinical trial
  2. Use site metrics to maintain/improve recruitment, enrollment and retention
  3. Develop all study documents necessary for trial execution
  4. Contribute to drafting of protocols, patient informed consent forms and case report forms
  5. Present study related topics to audiences
  6. Manage payments to sites
  7. Work independently and prioritize study related activities
  8. Travel on average 50% to assigned regional sites.

Qualifications

  1. 7+ years of experience in executing drug &/or medical device clinical trials (cardiovascular &/or venous studies experience preferred)
  2. 2+ years of experience monitoring clinical trials (medical device, cardiovascular &/or venous studies experience preferred)
  3. Ability to travel a minimum of 50% to assigned sites
  4. High proficiency using
  5. Cardiovascular study experienced a plus but not required; device study experience a plus but not required
  6. Microsoft Office Suite experience and proficiency as a user
  7. Ability to trouble shoot IT issues and quickly pick up new systems and processes
  8. Proficiency with common EDC and CTMS databases used in clinical trials
  9. Medical device experience preferred
  10. Previous experience working independently and remotely from home office
  11. Strong communication skills

Duties

  1. Perform all aspects of site nomination, selection, confirmation, execution, data collection, monitoring, and closure activities. 
  2. Develop strong customer relationships ensuring appropriate sponsor oversight of clinical research centers
  3. Drive site recruitment strategies, data quality, and patient compliance to protocol.
  4. Partner with study team to develop all study documents necessary for trial execution
  5. Contribute to drafting of protocols, patient informed consent forms and case report forms
  6. Deliver site training, updates, and study communication materials to sites
  7. Manage site payments, study contracts, consent approvals, IRB approvals, and other research processes with sites
  8. Maintain compliance to all SOP, GCP, and regulatory processes
  9. Ensure highest level of data quality at the site including driving resolution of queries
  10. Monitor selected sites through source data verification, Conduct Site Initiation Visits, Interim Monitoring visits, and close out visits.
  11. Drive high quality data collection to support scientific communications, clinical research, and statistics evidence dissemination strategies.
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