Job Description

Clinical Trial Specialist
 Job Number: 20-07368
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Trial Specialist for our client in Lawrenceville, NJ. 
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • Global Development Operations / Global Clinical Compliance & Continuous Improvement / Clinical Trial Transparency & Disclosure
  • The Clinical Trial Results Reporting Specialist is responsible for creation of the clinical trial summary results report form for ClinicalTrials.gov and EudraCT., the management of the review and approval process for these forms, and timely upload into the databases.
  • The Results Reporting Specialist will partner with Biostatisticians, Medical Monitors, Medical Writers, Operations Leads and IT.
 
Responsibilities:
  • Identifies result summary data to be disclosed based on the protocol and study report.
  • Creates the results reporting form for a clinical trial based on information found in the clinical study report.
  • Manages the review and approval process for the results form, uploads completed and approved forms to ClinicalTrials.gov and EudraCT.
  • Partners with GBS and external partners to ensure AE files for results disclosure are created and uploaded to the database.
  • Files reporting extensions (certificates of delay) when appropriate.
  • Liaises with Statisticians, Medical Monitors, Protocol Manager, and Medical Writers on all trials - operates as part of team to ensure the data best supports results and is consistent with other public forms of trial results (i.e. publication in a clinical journal)
  • Provides operational support for clinical trial registration maintenance
  • Assesses revised protocols for impact on registration, and works with the study team on registration updates.
  • Publishes CSR synopsis on Client.com
  • Contributes to improvements of clinical trial data disclosure processes and related documentation.
 
Qualifications:
  • BS, MS, or PhD in scientific or medical field
  • Minimum of 3 years overall work experience; 2+ years of relevant experience in a scientific, medical, or clinical research field.
 
Skills:
  • Demonstrated analytical skills.
  • Familiarity with clinical trial protocols and reports desirable.
  • Ability to work on results and protocols from multiple therapeutic areas.
  • Strong communication skills.
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Jay Lucas
arjay.lucas@eclaro.com
6463571240
Jay Lucas | LinkedIn
 
Equal Opportunity Employer:
Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
 
 

Application Instructions

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