Clinical Trial Assistant

7 days ago


Nutley, New Jersey, United States Lifelancer Full time

Overview



Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.



Job Description: Clinical Trial Assistant - Regulatory Compliance Specialist

The estimated salary for this position is around $65,000 per year, considering the location and industry standards.



Job Responsibilities:




  • Support all phases of clinical study activities under the direction and supervision by study Clinical Operations Lead(s).
  • Plan, create, and communicate clinical study timelines.
  • Gather input from cross-functional teams and create plans that help the team produce deliverables on schedule.
  • Ensure consistency of clinical study and processes across clinical trials.
  • Oversee and resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets.
  • Monitor progress and follow up with team members and line managers when issues develop.
  • Implement and prepare the clinical development strategy as outlined by the clinical teams.
  • Develop recruitment strategy for the trial in program.


Document Creation and Management:




  • Assist with creating, updating, and maintaining project trackers in EPIC.
  • Provide support for document preparation and follow-up (e.g., Informed Consent Form, eTMF filing plan, Co-Monitoring Plan).
  • Create Clinical Trial Agreement requests using the legal tracker and follows-up on original agreements and amendments.
  • Coordinate reviews for essential materials such as ICFs and Co-monitoring plans.


CRO and Vendor Contributions:




  • Assist in managing ancillary supplies with vendor/sites.
  • Assist COL with action Item follow-up.
  • Attend CRO and vendor teleconferences as applicable.
  • Review regulatory packet for investigational product release.
  • Provide user access management support; tracking certifications and maintain statuses of study team members.
  • Assist with investigator meeting planning, including entering clinical meetings into Eisai internal systems.
  • Attend investigator meeting when applicable.


Financial Contributions:




  • Track invoices and support the vendor reconciliation process.
  • Adhere to financial standards, guidelines, and compliance requirements.


Requirements:




  • Bachelor's Degree (US).
  • Proficient in MS Outlook, Word, PowerPoint, and Excel.
  • Basic understanding of study-related documentation.
  • eTMF (Veeva) experience preferred.
  • Ability to work with global teams utilizing different media (email, virtual meetings, teleconferences).
  • Must have good attention to detail.
  • Ability to multitask and show flexibility with changing project-specific priorities.
  • Effective communication across cross-functional teams, vendors, and CROs.
  • Demonstrate cooperative and professional behavior with colleagues and vendors.
  • Possess interpersonal skills to work with all functional areas and levels.
  • Possess strong organizational skills.


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