Clinical Research Associate

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Jersey City, NJ
$1.00 - $1.00
Job Type
Jul 11, 2018
Job ID
Pharmaceutical company in Jersey City, NJ in need of Clinical Research Associate

Responsible for monitoring of single and multi-site clinical trials.  Assures adherence to international Commission on Harmonization (ICH), Good Clinical Practices (GCP), and Code of Federal Regulations (CFR).  Assures compliance with institutional Standard Operating Procedures (SOPs) and Policies, protocol requirements, and institutional reporting requirements.  Performance of this position requires coordination and interaction among various research teams and team members.
Essential Duties
  •  Works side-by-side with Clinical Project Manager(s) in providing assistance to efficiently and effectively monitor the clinical trial(s) progression including sponsor’s vendor/CRO oversight, compliance with systems use, ensure accuracy of data quality for subject safety.
  • Liaises with CROs and other clinical vendors as directed to ensure deliverables are met and methods of communication are developed to facilitate efficient work flow
  • Liaises with Investigators and clinical site staff as appropriate to ensure optimal Sponsor-Site relationships as required
  • Must have a thorough understanding of clinical trial protocols, data collection requirements, and methodologies.
  • Must be able to recognize clinical values and abstract data from source documents and possess analytical ability to identify data or patient safety issues.
  • Ensures clinical trial activities are conducted in a timely manner.
  • Assist in site visits such as pre-qualification, initiation, monitoring, close out, audit, etc. and activities for single and/or multi-investigational sites in accordance with designated project assignments (including applicable SOPs, ICH, GCP and applicable international/national regulatory requirements).
  • Provides administrative support and meeting coordination for clinical trials in scheduling, preparing presentations, agendas, action logs and minutes. This will include advisory committee meetings and investigator meeting support, study training (if applicable), and development of study documents.
  • Assist with the development and review of clinical trial documents as requested by the Clinical Project Manager (e.g., protocols, ICF, IRB reports and study related plans)
  • Set-up, update and maintain clinical trial-related trackers such as regulatory documents, trial master file, start-up progress, screening/enrollment, study invoices/payments, project budgets and others as necessary;
  • Prepare, maintain, and archive trial master files;
  • Perform trials master file reviews to ensure completeness and audit-readiness;
  • Reviews investigator’s study file to ensure that all documents are ready for an audit and/or site inspection, and discuss pertinent study materials retention and publication policy.
  • Execute assigned work efficiently and adhere to project timelines
  • Assists the Clinical Project Manager to ensure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with ICH current GCP, FDA CFR, along with other applicable Sponsor and regulatory requirements, requirements of host countries and other government regulations.
  • Performs various project tasks as assigned by Clinical Project Manager
  • Must be able to work independently and with others.
  • Location: Jersey City office
  • Duration: 6 months, and then renewable
  • Much of the work is administrative clinical trial work related to critical administrative tasks:
  • Preparing and maintaining clinical trial management files
  • 1st pass/review of monitor visit reports for the clinical team
  • Internal meeting minutes drafting and finalization
  • Liaising with clinical trial site staff
  • Track and ensure clinical trial activities are conducted in a timely manner
  • Will participate in audits- the CRA is key to maintaining the clinical study documentation is audit-ready at all times