Clinical Trial Associate

  • location: Madison, NJ
  • type: Contract
  • salary: $33.62 - $39.56 per hour
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job description

Clinical Trial Associate

job summary:
Clinical Trial Associate

 
location: Madison, New Jersey
job type: Contract
salary: $33.62 - 39.56 per hour
work hours: 9 to 5
education: Associate
 
responsibilities:
Job Responsibilities

  • Support study feasibility activities and perform database/web searches for sites as needed.
  • Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation.
  • Organize and maintain project working files and track critical documents. Report discrepancies to the appropriate clinical team member in a timely manner.
  • Reconcile and transmit all essential documentation to CDIC as per Forest policy.
  • Track and assist with processing site/vendor payments. Follow up on any issues as required.
  • Collect and track patient enrollment information and update study management reports as necessary.
  • Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems.
  • Assist senior team members with in the planning, preparation, and on-site support of investigators meetings.
  • Generate reports in various applications to assist the Clinical Scientist to perform clinical data review.
  • Assist with ongoing data review and discuss comments with the clinical study team as needed.
  • Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings.
  • Provide input and support in the development and distribution of monthly site newsletters.
  • Support the Regional Site Managers by providing study related information and supplies, as requested.
  • Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues.
  • Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies).
  • Contribute to process improvement efforts including task forces and committees.
  • Support clinical team with requests from management as needed.
  • May deliver training related to day-to-day responsibilities for new CTA and CS hires within department.
  • May provide administrative support to manager/group as assigned.
  • Manage calendars and appointments. Resolve scheduling conflicts as needed.
  • Manage and coordinate travel requirements for group, consultants, and partners.
  • Prepare and oversee expense account reporting. May contribute to tracking budgets as needed.
  • Support document filing and organizing as needed.
  • Schedule and coordinate new hire candidate interviews.
  • Coordinate and process office supply orders.
  • Function as a back up to general Clinical Scientist activities as needed.
 
qualifications:
Education & Qualifications

  • Associate degree or higher preferred
  • 1-2 year relevant experience in pharmaceutical industry or CRO
  • Experience supporting clinical trials preferred
  • Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus
  • Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
  • Strong skills with Microsoft Excel required
  • Experience using electronic data capture (EDC) systems is a plus
  • Must possess excellent skill/ability in the following:
  • Oral and Written Communication
  • Organizing
  • Judgment and Problem Solving
  • People Relationships
  • Initiative and Accountability
  • Ability to manage multiple tasks
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
 
skills: FDA, GCP (Good Clinical Practice), Study Planning, EDC (Electronic Data Capture), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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