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

Date Posted: 4/13/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    4/13/2018
  • Job ID:
    840123

Job Description


Apex Life Sciences is looking for a Clinical Trial Associate to join our Global Bio-pharma company. The ideal candidate will have Global Study, Phase III experience, 3+ years experience, BS/BA (or equal work experience), experience with Monitoring visit report review, ICF review, financial reconciliation, creating/reviewing study plans, IP reconciliation, work on in-sourced and outsourced studies, must have prior Pharma experience.

This is a contract role with the possibility to convert to permanent.

For immediate consideration, email resumes to: mbingham@apexlifesciences.com

Responsibilities will include, but are not limited to, the following: 

Prerequisites: 

  • Completed BA/BS in directly-relevant discipline or equivalent experience required; and 
  • At least 3 years experience as CTA (or comparable operating experience) in pharmaceutical, CRO, or healthcare environment(s) required.

Summary/Scope:

  • The Clinical Trials Associate (CTA) is involved in the conduct of the study and interfaces with the Study Manager and the Study Team.
  • The CTA also supports the Study Team by creating and distributing study team materials, tools and documents.
  • Responsibilities will vary slightly based on whether the study is insourced or outsourced, phase of the study lifecycle (start up, maintenance, close out).
  • Candidate should have experience with insourced and outsourced studies.

Responsibilities include, but are not limited to, the following:

  • Creating and or reviewing study plans, specification documents, materials and tools.
  • Ability to communicate clearly both verbally and written to sites, vendors, CROs, internal study team, etc.
  • Track study progress in CTMS including patient enrollment and patient status, Oversight of Regulatory documents for site initiation.
  • Provide access to systems when applicable.
  • Track and ensure training of study team.
  • QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
  • Process and track payments to vendors and study sites as appropriate.
  • Oversee TMF Quality Review for study team, complete TMF QC for department on a quarterly basis for each study Collecting, quality review and submitting documents to the TMF. 
  • Performing QC of TMF as appropriate. 
  • Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors. 
  • Generate, finalize and distribute study team agendas and meeting minutes. 
  • Assist with generating the CSR appendices and participate in SOP and WP development. 
  • Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives. 

Skills/Knowledge Required: 

  • Completed BA/BS in directly-relevant discipline or equivalent experience required. 
  • At least 3 years experience as CTA (or comparable operating experience) in pharmaceutical, CRO, or healthcare environment(s) required. 
  • Computer skills - MS office suite 
  • CTMS (TW, Celtrak) 
  • Knowledge of databases 
  • Efficient at meeting planning / generating minutes 
  • Understanding / familiarity with drug development and process and Pharma 
  • Strong Verbal and written communications skills 
  • Self starter / proactive 
  • Ability to work independently 
  • Good listener / problem solver 
  • Ability to prioritize and multi-task and demonstrate flexibility and attention to detail 
  • Familiarity with ICH / GCP and regulatory guidelines/directives 
  • Team player and ability to build relationships 
  • Strong organizational skills 
  • Proficient at Vendor / site payment process 
  • Knowledge of medical/scientific terminology 


Cross cultural awareness Key Competencies: 

  • Commitment to quality 
  • Works efficiently 
  • Demonstrate adaptability and flexibility 
  • Acts with integrity 
  • Works independently 
  • Shows work commitment 
  • Prepares written communication 
  • Uses technical / functional expertise 
  • Fosters teamwork 
  • Proactive behavior 
  • Listens to others

#LI-MB1