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Clinical Trial Associate

4 months ago

Pennington, United States i-Pharm Consulting Full time

Key Responsibilities:

  • Support the Clinical Operations team in executing clinical trials, initially in the US with potential expansion abroad.
  • Manage and maintain the electronic Trial Master File (eTMF) for multiple US-based studies.
  • Ensure proper access controls for clinical trial documentation.
  • Develop and maintain systems for the receipt, tracking, and archiving of clinical trial documents.
  • Assist in start-up, maintenance, and close-out activities for investigation sites, focusing on records management.
  • Manage IRB initial submissions and ensure all IRB-related approvals and correspondence are archived in the eTMF.
  • Provide administrative support, including drafting meeting agendas and minutes.
  • Liaise with facilities, shipping vendors, postal services, and IT.
  • Manage filing systems for non-TMF documentation.
  • Participate in the development and amendment of SOPs related to trial master file procedures.
  • Maintain databases for publication materials and investigative sites.
  • Conduct background research on potential investigators and prospective vendors.

Qualifications:

  • Strong understanding of Good Documentation Practice and ICH GCP compliance, specific to the management of Essential Documents.
  • Knowledge of US regulatory requirements related to essential documents and SOPs.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat.
  • Excellent organizational, verbal, and written communication skills.
  • Fluent in English.
  • Flexibility to occasionally attend meetings outside traditional work hours due to the international nature of the organization.
  • Ability to work independently with minimal supervision.
  • Physical ability to lift archiving boxes (up to 25 lbs).
  • Strong interpersonal skills for effective collaboration.

Education and Experience:

  • Minimum Associate's Degree, Bachelor's Degree preferred.
  • At least 3 years of relevant experience as a clinical trial assistant or documentation specialist, or equivalent.
  • Experience in the Pharmaceutical Industry or with a Contract Research Organization (CRO).
  • Familiarity with TMF maintenance, auditing, and reconciliation.
  • Experience managing Trial Master Files (TMF) and readiness for audits.
  • Proficiency with electronic document management systems (eTMF, CTMS, etc.).
  • Experience with Excel, including chart development and basic functions.
  • Experience in archival of paper files and auditing archived files.
  • Meeting agenda and minute-taking experience.
  • Experience with data management systems and safety databases is a plus.
  • Experience working on international clinical trials and interacting with IRBs.
  • SOP development experience.
  • Training experience for new and existing employees on procedures.
  • Calendar management experience.
  • Experience interacting with investigational sites.

Travel:

  • Minimal travel required.

Work Environment:

This is an office-based position located in Pennington, NJ. The role involves frequent sitting, standing, walking, and computer use. Reasonable accommodations can be made for individuals with disabilities.

Desired Skills and Experience

My client is a leading biotech research organization dedicated to advancing clinical research and development with a focus on quality and safety. Their parent company has a significant presence in global markets and partnerships with top-tier international pharmaceutical companies, leveraging over 50 years of manufacturing and development expertise. Their mission includes the development of novel therapeutics and new chemical entities.