CRA Assistant

October 12, 2024

Thermo Fisher Scientific

Lagunilla

OTHER

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Job Overview: We are seeking a detail-oriented and proactive CRA (Clinical Research Associate) Administrative Assistant to support our clinical research team. The successful candidate will provide administrative and clerical support to ensure the efficient operation of our clinical research activities. This role requires excellent organizational skills, attention to detail, and the ability to handle multiple tasks simultaneously.
Responsibilities:
Administrative Support:

Provide administrative support to the CRA team, including scheduling meetings, managing calendars, and coordinating travel arrangements.
Prepare and maintain documentation, reports, and correspondence related to clinical trials.

Document Management:

Assist in the preparation, review, and filing of regulatory documents, study protocols, informed consent forms, and other trial-related documents.
Ensure all documents are accurately filed and maintained in compliance with regulatory requirements and company policies.

Data Entry and Management:

Enter and maintain accurate data in clinical trial databases and systems.
Assist in the collection, verification, and organization of trial data and records.

Communication:

Act as a point of contact for internal and external stakeholders, including study sites, vendors, and regulatory authorities.
Facilitate effective communication between the CRA team and other departments.

Meeting Coordination:

Schedule, organize, and prepare materials for meetings, including agendas, minutes, and presentations.
Assist in the coordination of investigator meetings, site visits, and training sessions.

Compliance and Quality Assurance:

Assist in ensuring compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and company standard operating procedures (SOPs).
Support quality control and quality assurance activities related to clinical trials.

Inventory and Supplies Management:

Monitor and manage inventory of clinical trial supplies and materials.
Coordinate the ordering and distribution of supplies to study sites as needed.

Requirements:
Education:

High school diploma or equivalent required; Associate’s or Bachelor’s degree in a related field preferred.

Experience:

Previous experience in an administrative or clerical role, preferably within a clinical research or healthcare environment.

Skills:

Excellent organizational and time-management skills.
Strong attention to detail and accuracy.
Proficiency in Microsoft Office Suite (Word, Excel, Power Point, Outlook) and clinical trial management systems.
Effective communication and interpersonal skills.
Ability to handle confidential information with discretion.

Attributes:

Proactive and self-motivated with the ability to work independently and as part of a team.
Flexible and adaptable to changing priorities and deadlines.
Strong problem-solving skills and the ability to multitask effectively.

Working Conditions:

This position may require occasional travel to clinical trial sites and meetings.
The role is primarily office-based, with some flexibility for remote work depending on company policies.