Skip to Content
Clinical Trial Assistant

Job Description

SUMMARY: 

  • Responsible for supporting the Clinical Trial Management/operational study team to manage the various aspects of the operational execution and delivery of quality studies, including in process quality control activities.

RESPONSIBILITIES: 

  • Supports the Clinical Trial Management/operational study teams in the execution and delivery of studies 
  • 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 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 Trial Managers to perform clinical data review. 
  • Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings. 
  • 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). 

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 

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 [Click Here to Email Your Resumé] or 844-463-6178.

Job Snapshot

Employment Type Contractor
Job Type Other
Education 2 Year Degree
Experience 1 to 2 years
Manages Others Not Specified
Industry Other Great Industries
Required Travel Not Specified
Job ID 806041
CareerBuilder Tip:
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder.com you are agreeing to comply with and be subject to the CareerBuilder.com Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.

Clinical Trial Assistant


Enter notes about this job:

Cancel