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Clinical Trial Associate
ProKidney, LLC Raleigh, NC
$54k-70k (estimate)
Full Time 7 Days Ago
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ProKidney, LLC is Hiring a Clinical Trial Associate Near Raleigh, NC

  • Study entry and updates to ClinicalTrials.gov.
  • Assists with internal training records for staff such as scheduling training sessions and updating files with training records for staff.
  • Assists with internal eTMF for audit readiness.
  • Assists clinical team with vendor eTMF quality checks.
  • Assists clinical team with vendor EDC quality checks.
  • Assists with weekly reporting of clinical trial vendor updates to executive management.
  • Assists with the info@prokidney.com inquiries including responding and tracking associated metrics for weekly reporting.
  • Assists with coordination of vendor and KOLs including setting up contracts and processing invoices as requested.
  • Gather data and formatting for documents, managing timelines for submission deadlines such as compiling comments from internal reviews and formatting.
  • Ad hoc requests as made by clinical functional group.
  • Create, modify and format slides for the clinical team to assist with KOL/vendor meetings/ad hoc committee meetings.
  • Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards.

Requirements

Education/Training

Bachelors degree

Licenses/Certifications

GCP Training 

Experience

1 years clinical trial experience

Skills/Abilities

• Basic understanding of clinical drug development and GCP and familiarity with regulatory requirements for conduct of clinical trials.

• Strong attention to detail. 

• Excellent written and oral communication skills. 

• Able to effectively use information technology with a proficiency in MS Outlook, Word, Excel and PowerPoint. 

• Exceptional planning and organizational skills. 

• Ability to multi-task and use good judgment when making decisions.

Job Summary

JOB TYPE

Full Time

SALARY

$54k-70k (estimate)

POST DATE

05/08/2024

EXPIRATION DATE

07/07/2024

WEBSITE

twincitybio.com

HEADQUARTERS

Winston Salem, NC

SIZE

<25

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