Clinical Trial Associate - NJ in Summit, NJ at Apex Life Sciences

Date Posted: 9/26/2018

Job Snapshot

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

Job Description

The Clinical Trial Coordinator (CTC) is responsible for providing in-house support and assistance to assigned study teams and GTMM. Administrative experience or working knowledge of MS Office.

Experience with TMF and quality review, working on a study team, GCP/ICH guidelines,

Strong understanding of different Regulatory Start up documents, Regulatory and Pharmacy binders, experience with minute taking, setting up meetings, SharePoint a plus, working with a global team, interacting with different role levels throughout an organization. Strong communication skills both verbal and written.

Skills/Knowledge Required: *

  • Good written and oral communications skills with understanding of written and oral English, uses different communication methods appropriately 
  • Excellent organizational and administrative skills 
  • Experience supporting study teams 
  • Self-starter and proactive self-learner 
  • Hold self-accountable for actions and results  
  • Ability to multi-task effectively and prioritize assignments from multiple sources
  • Ability to work with limited day to day supervision
  • Ability to function productively in a fast paced and rapidly changing environment, demonstrate flexibility
  •  Ability to resolve routine problems independently and escalate to management appropriately
  • Identifies and/or supports new solutions, opportunities, and initiatives to improve products, services, and work processes
  • Maintains high quality while meeting deadlines and commitments
  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, Powerpoint, Outlook
  • Experience filing paper and electronic study documents, and conducting QC/reviews
  • Experience with IP reconciliation * SharePoint experience a plus.
  • CRO or pharma experience - at least 2 years in Clinical Operations preferred with knowledge of clinical trial phases, terminology and functional study team roles. Responsibilities will include, but are not limited to, the following:
  • Support study teams in administrative tasks, meeting minutes and logistics
  • Prepare and track CDAs
  • Assist with collection and tracking of study documents
  • Create and maintain Study Document Shared Locations
  • Assist with TMF set-up, ongoing quality review, and final reconciliation
  • Send original documents to central TMF, and ensure electronic filing
  • Support Health Authority inspections and CQA audits as required
  • Maintain and update data as appropriate in study management tools
  • Assist with reconciliation of IP
  • Manage local translations, printing for required local documents
  • Manage site file binders activities for in-sourced studies
  • Assist with compilation and QC of Clinical Study Report appendices
  • Support the development/coordination of study training materials
  • Support the study specific training matrix
  • Assist with granting / removing systems and Sharepoint accesses
  • Run reports from internal databases and display appropriate formatting
  • Assist with internal and external distribution of IP, documentation, and communication as appropriate
  • Support the production, coordination, completeness and accuracy of IRB/EC submissions for in-sourced studies

To apply to this position please send your resume to:Vickie Dagit,


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.