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Clinical Research Coordinator

2 months ago

Exton, Pennsylvania, United States Eisai Full time

At Eisai, our commitment to addressing unmet medical needs and enhancing healthcare benefits for patients, their families, and caregivers is central to our human health care (hhc) mission. As a progressive pharmaceutical organization, we are making significant strides in neurology and oncology, with a robust focus on research and development. Our legacy includes the creation of numerous groundbreaking medications, including the world's most widely-utilized treatment for Alzheimer's disease. As we continue to grow, we are looking for dedicated individuals who thrive in a dynamic environment and are eager to contribute positively.

Position Overview

The Clinical Trial Assistant will play a crucial role in supporting various stages of clinical study operations (feasibility, initiation, execution, and closure) under the guidance of the Clinical Operations Lead(s). This role involves planning, assisting, creating, and communicating clinical study timelines. The Clinical Trial Assistant will gather insights from cross-functional teams to develop plans that ensure timely deliverables. They will ensure uniformity in clinical studies and processes across trials, managing operational elements in collaboration with project teams while adhering to standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations, including site and vendor selection and preparing clinical trial budgets. The assistant will ensure compliance with clinical trial protocols and monitor progress, following up with team members and supervisors when challenges arise. They may also assist in formulating recruitment strategies for the trial program.

This role may be office-based (hybrid) or remote.

Key Responsibilities

Clinical Trial Contributions:

  • Maintains and tracks study information, providing updates on study progress as required.
  • Participates in internal study team meetings; prepares agendas, takes minutes, and distributes meeting documentation.
  • Assists with eTMF setup requests and manages project documentation filing and archiving within specified timelines.
  • Conducts internal reviews of eTMF and reconciles study files.
  • Performs quality checks on eTMF documentation with follow-up for any missing items under the supervision of the Clinical Operations Lead.
  • Provides enrollment statistics to the Clinical Operations Lead or leadership team as needed.
  • Contributes to inspection readiness by organizing various folders and trackers for the eTMF and other required documents.
  • Maintains the sponsor team member assignment list for Eisai systems.
  • Tracks Serious Adverse Event (SAE) safety reports and provides updates to the Contract Research Organization (CRO).
  • Initiates and compiles clinical trial documentation related to Clinical Study Reports (CSR) appendices.
  • Acts as the central point of contact for the clinical team regarding designated projects and documentation.

Document Creation and Management:

  • Assists in creating, updating, and maintaining project trackers in EPIC.
  • Supports document preparation and follow-up, including Informed Consent Forms and eTMF filing plans.
  • Creates Clinical Trial Agreement requests using the legal tracker and follows up on agreements and amendments.
  • Coordinates reviews for essential materials such as Informed Consent Forms and Co-monitoring plans.

CRO and Vendor Contributions:

  • Assists in managing ancillary supplies with vendors and sites.
  • Supports the Clinical Operations Lead with action item follow-ups.
  • Participates in CRO and vendor teleconferences as applicable.
  • Reviews regulatory packets for investigational product releases.
  • Provides user access management support, tracking certifications and statuses of study team members.
  • Assists with planning investigator meetings, including entering clinical meetings into Eisai internal systems.
  • Attends investigator meetings when applicable.
  • Performs additional tasks or responsibilities as assigned.

Financial Contributions:

  • Tracks invoices and supports the vendor reconciliation process.
  • Adheres to financial standards, guidelines, and compliance requirements.

Technical Competencies:

  • Develops knowledge of resource planning and project tools.
  • Gains foundational understanding of healthcare providers and key opinion leader contributions.
  • Acquires fundamental knowledge of clinical trial execution, CRO responsibilities, and relevant functional areas.
  • Tracks and completes individual expenditures as applicable.
  • Follows financial standards, guidelines, and compliance requirements.
  • Proficient in Microsoft Outlook, Word, Excel, and PowerPoint.
  • Understands and utilizes eTMF, Epic, EDGE, IRT, eDC, and other Eisai internal systems as relevant.

Qualifications

  • Bachelor's Degree (US).
  • Proficient in Microsoft Outlook, Word, PowerPoint, and Excel.
  • Basic understanding of study-related documentation.
  • eTMF (Veeva) experience preferred.
  • Ability to collaborate with global teams using various communication methods.
  • Strong attention to detail.
  • Ability to manage multiple tasks and adapt to changing project priorities.
  • Effective communication skills across cross-functional teams, vendors, and CROs.
  • Demonstrates professionalism and cooperation with colleagues and vendors.
  • Possesses interpersonal skills to engage with all functional areas and levels.
  • Exhibits strong organizational skills.

Eisai Salary Transparency Language:

The base salary range for the Clinical Trial Assistant is from $30,000 to $60,000. Under current guidelines, this position is eligible to participate in the Eisai Inc. Annual Incentive Plan.

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, please inquire.

Eisai is an equal opportunity employer and is committed to recruiting, hiring, training, and promoting in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability, or veteran status. Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify, an Internet-based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.