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

Date Posted: 9/11/2018

Job Snapshot

  • Employee Type:
  • Location:
    Madison, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

  • 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) 


  • 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: 

1. Delivers Business Results 

  • Execute study start-up for assigned protocols within sponsor timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines. 
  • Monitor project plans and communicates and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness at the Investigator Meeting. 
  • Ensure the accuracy and quality of site start-up deliverables by reviewing deliverables in reference to standards. 
  • Review and report on deliverables of vendors. 
  • Maintain the tracking of project metrics in Site Start-Up tracker and provide status updates. 
  • Work with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, and Clinical Planning). 

2. Enhances Organizational Performance 

  • Manage information sharing (i.e. Site Start-Up tracker, Site Identification Tracking Tools). 
  • Develop Standard Operating Procedures and Working Documents to document and communicate unit’s processes and procedures. 
  • Actively share new ideas for efficient and seamless processes during study team meetings. 
  • Aggressively seek input from other departments on process improvement and implements process improvement for Site Start-Up initiatives. 
  • Provide agendas, meeting minutes and manages follow up items for all Site Start-Up meetings that are assigned. 
  • Follow standard processes for the collection and processing of study site start-up documents and site start-up information. 
  • Proactively inform manager of down-turns in leading site start-up indicators 
  • Maintain all aspects of Site Start-Up portal documentation by updating trackers and providing frequent study updates. 

3. Demonstrates Personal Leadership 

  • Provide oversight and direction to vendors related to site start up tasks by overseeing timely delivery of regulatory documents, reviewing documents for quality, providing feedback on quality of vendor deliverables and providing direction to vendor on task requirements and prioritization. 
  • Attend clinical team and operational team meetings and provides updates on the timely execution of inter and intra-departmental milestones. 
  • Schedule and lead site start-up meetings with clinical team and vendors to review any issues, items for escalation, regulatory document issues, and IRB status. 
  • May mentor junior staff members to improve quality of outcomes and to maintain team morale. 

Required Experience: 

  • Bachelor's degree
  • At least 3-5 year’s experience in clinical research 
  • Prefer candidate with prior experience as Study Start-Up Specialist 
  • Must be willing to travel about 10%


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.