CTA in Durham, NC at Apex Life Sciences

Date Posted: 11/7/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/7/2018
  • Job ID:
    910890

Job Description


Job Title: Clinical Trial Assistant

Department:    Clinical Development                 

Reports To: Amanda Mathis, Ph.D.    


JOB SUMMARY:

As a Clinical Trials Assistant, you will be responsible for supporting the clinical development team to ensure the most effective and efficient conduct of clinical research studies by providing administrative and project support.

DUTIES AND RESPONSIBILITIES:

The Clinical Trial Assistant will support the clinical development program for one or more product candidates, with one or more indications, from early development to regulatory approval and beyond, in order to achieve a high-quality product for the marketplace and business success for the company.  Primary responsibilities follow:

  • Establish and maintain effective communication and collaboration with functional area peers, including regulatory, quality assurance, project management, and Clinical Research Associates in order to meet program objectives and support achievement of department and corporate goals.

  • Implement and maintain internal processes and systems to support the efficient and high quality conduct of clinical trials including (where applicable) clinical trial management systems (CTMS), trial master files (TMFs) and SharePoint internal document repositories.

  • Assist with the setup, organization, and maintenance of study-specific TMFs including sending study specific documents and communication to TMFs as well as filing, tracking and archiving of essential documents.

  • Assist with formatting/production/distribution of key study documents (i.e., essential regulatory documents) in addition to compiling regulatory site release packages for the initial reviwer.

  • Assist in the preparation, handling, distribution, filing and archiving of clinical documentation and reports per standard operating procedures.

  • Assist with the shipment of essential regulatory documents and supplies to sites. Maintenance/ tracking of sites’ study supplies, including confirmation of destruction/ return at the close of each study, as needed throughout the course of each study.

  • Point of contact for assistance with general department operations including but not limited to: team communications/ distributions and aid to managers with onboarding of new employees/ contractors.  

  • Attend project team, department, and non-study specific meetings and distribute/generate meeting agendas and minutes.

  • Provide aid with departmental expenses: receiving, tracking of contract executions/ amendments, purchase order set-up and maintenance against established budgets.

  • Bachelor’s degree and 2 years’ experience in a pharma, biotech, and/or CRO setting.  

  • Must be able to work independently, adapt to changing priorities, with the ability to take initiative to complete tasks accurately and timely

EDUCATION/EXPERIENCE/SKILLS

Four-year degree with pharmaceutical development experience gained ideally in a Sponsor and/or CRO role. Hands-on experience with supporting one or more clinical programs at a given time. Knowledge of Good Clinical Practice (GCP) regulatory requirements and International Conference on Harmonization (ICH) guidelines. Ability to understand scientific literature. Ability to identify team needs and suggest/implement solutions for improved departmental functionality. Must be a highly motivated self-starter who is capable of taking initiative and sees projects through to completion with minimal supervision.




910890