Site Start-Up Specialist in Madison, NJ at Apex Life Sciences

Date Posted: 2/1/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Madison, NJ
  • Job Type:
    Other
  • Experience:
    3 to 5 years
  • Date Posted:
    2/1/2018
  • Job ID:
    818790

Job Description


I. POSITION SUMMARY: 

  • The Site Start-Up Specialist is responsible for executing study start-up for assigned protocols with the goal of meeting study start-up timelines.
  • Monitor project plans to meet Site Initiation Readiness at the Investigator Meeting.
  • Ensure the accuracy and quality of deliverables from clinical team and vendors.
  • Maintain project metrics and provide status updates to senior management. 
  • Proficiency with the following tasks is desired: 
  • Site Regulatory Documents Collection (FDA Form 1572, Signature Pages, etc.) 
  • Review of Informed Consent Form(s) in order to obtain IRB approval (interface with Legal, Medical Safety Physician, and Study Team for approval of language changes) 

II. PRIMARY JOB RESPONSIBILITIES: 

  • Capable of performing all of the activities and responsibilities with direction of the Site Start-Up Unit Manager, Global Monitoring Operations: Director, Associate Director, or designee as follows: 

IV. POSITION QUALIFICATIONS: 
Education: 

  • Qualified candidates will have a bachelor’s in life sciences or related field 


Experience: 

  • At least 3-5 year’s experience in clinical research 
  • Prefer candidate with prior experience as Study Start-Up Specialist 
  • Knowledge, Skills, and Abilities 
  • Knowledge of FDA regulations required. 
  • Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook 
  • Experience with Adobe Acrobat Professional and Microsoft Access a plus 
  • Must possess excellent skill/ability in the following: 
  • Written and Oral Communication 
  • Presentation Delivery 
  • Planning and Organizing 
  • Decision Making, Judgment, and Problem Solving 
  • People Relationships, Influencing Others, Motivating Employees, Team Building 
  • Initiative and Accountability 
  • Proven ability to interact with different functional groups 
  • Ability to easily adapt to a changing environment

To apply for this position please send resume to:

Vickie Dagit, Recruiter

vdagit@apexlifesciences.com