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Clinical Study Associate II in Bernards, NJ at Apex Life Sciences

Date Posted: 11/22/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/22/2018
  • Job ID:
    906593

Job Description


Summary:

Apex Life Sciences is looking for multiple Clinical Study Associates for one of our top clients.

Duties: 

  • Assist in logistical planning and conduct of IIS (Investigator Initiated Studies)
  • Review committee meetings, under the close supervision of the Global IIS Manager Global Medical Affairs Clinical Operations, in adherence Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. 
  • Key focus is on providing clinical administrative support to the Global IIS Manager and each committee pre, during and post each meeting.
  • This includes preparing meeting logistics, distributing agendas and review materials, taking minutes at IIS meeting as well as interacting with functional team members to ensure timely collection of all documents.
  • Support and assist the transmittal of IIS documents to the appropriate shared drive or SharePoint site.
  • Update and maintain the IIS document tracker; updating slide decks.
  • Bring any logistical issues to the attention of the Global IIS Manager. 
  • Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).

Requirements:

  • An associate degree or associate nursing degree/diploma with relevant clinical development experience is acceptable.
  • Bachelor’s degree or higher preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.
  • Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO).
  • Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Basic oral and written communication skills.

To apply to the position please send resume to: Vickie Dagit, vdagit@apexlifesciences.com

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.




906593