Clinical Trial Associate

BBBH36113_1716547177
  • $60000 - $80000 PER ANNUM
  • Pennington, New Jersey
  • Permanent

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.

Camila Laugé-White Executive Consultant

Apply for this role