Clinical Trial Assistant I

Clinical Trial Assistant I

The Opportunity:

This is a unique opportunity for an entry-level Clinical Operations Professional. As a Clinical Trial Assistant I (CTA I), you will be responsible for acting as an integral member of the clinical study team(s) and will be tasked to support the execution and management of clinical trials. Reporting into the Sr. Clinical Program Manager (Sr. CPM) you will play a critical role in ensuring trials and studies align with all applicable standards.

Responsibilities:

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  Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guideline
  
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  Assist in the development, review, distribution, and archiving of study specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.)
  
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  CTA I will support the set-up and maintenance of the trial master files (TMF), if applicable, and work with the contract research organization (CRO) to audit and resolve discrepancies.
  
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  Assist project team(s) with sample management and generate trial progress tracking systems.
  
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  Tracks and prepare study-specific information utilizing databases, trackers, and other study tools.
  
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  Assist in the preparation of meeting materials, including scheduling, developing agendas, and minute-taking for internal study team meetings.
  
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  Gather investigator and site information to support study start-up, maintenance, and close-out activities.
  
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  Assist in contacting investigator sites to provide study specific information.
  
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  May serve as the point of contact for study sites and study monitors for clinical supplies, document collection, and preparation for close-out visits.
  
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  Work with cross-functional study teams and vendors to assist in the coordination of clinical trial activities.
  
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  Liaise with Clinical Supply and other cross functional teams with processing shipments, returns, and assists with in-house drug, specimen, and ancillary supply reconciliation.
  
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  Support other clinical operations activities as appropriate
  

Required Skills, Experience and Education:

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  Bachelor’s degree in biological sciences or health-related field required.
  
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  1 year (CTA I) relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
  
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  Has knowledge of GCP ICH Guidelines.
  
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  Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  
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  Excellent written/verbal communication and interpersonal skills.
  
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  Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  
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  Travel may be required (~10%)
  

Preferred Skills:

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  Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)
  
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  Oncology experience preferred.
  
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  Attention to detail.