Sr Centralized Study Associate

MEX Fortrea Clinical Development Mexico; Ciudad de México; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A global clinical research organization is seeking a dedicated Sr Centralized Study Associate in Mexico City. This role involves managing clinical systems, supporting study teams with data review, and ensuring regulatory compliance through document review. Candidates should have a degree in life sciences and 3-5 years of clinical research experience. Join a collaborative team focused on delivering transformative therapies to patients in need.

Formación

• Bachelor's degree in life sciences or equivalent certification from an accredited institution.
• 3-5 years experience in clinical research with knowledge of ICH-GCP guidelines.
• Strong organizational and communication skills.

Responsabilidades

• Manage clinical systems and maintain study databases.
• Support the study team in data review and related activities.
• Generate study reports and perform analysis.
• Review Investigator Packages for regulatory compliance.

Conocimientos

Attention to detail

Effective communication

Organizational skills

Educación

University/College Degree (Life Science preferred)

Certification in an allied health profession

Descripción del empleo

About Us

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers keines wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Position Overview

We are seeking a dedicated Sr Centralized Study Associate to join our team. The successful candidate will be responsible for:

Responsibilities

• Clinical Systems & Access Management: Managing clinical systems and access. Maintaining study databases (CTMS, IWRS, EDC, etc.). Supporting the study team in data review and other related activities. Tracking and following up with CRAs for outstanding issues. Generating study‑specific reports. Managing internal/external communications. Assisting in ensuring training compliance for study teams. Managing study payments (Site and Vendor).
• Data Review: Following up with CRAs for resolution of outstanding issues/action items. Ass_binaryresser the Lead with study‑specific data review tasks. Drafting and sending study‑specific reports. Performing other data review‑related tasks as instructed by the project team.
• Document Review: Reviewing Initial/Amended Investigator Packages for regulatory compliance. Reviewing amended Country/Site Informed Consent Forms. Filing amended Informed Consent Forms and Investigator Package approval documentation in TMF and eTMF. Reviewing Investigator Package Plans as per SOP with manager oversight.
• Study Support: Generating study reports and performing analysis. Managing access on applicable study systems. Setting up study systems for new awarded studies. Ensuring CTMS compliance. Managing project communications. Assisting project teams with study support activities.
• Investigator Payments: Reviewing EDC, contracts, and marking line items for payment. Coordinating payment batch generation in CTMS. Performing invoice QC and preparing GIA as applicable. Coordinating with CTL and PM for approvals. Processing Out of Pocket and Pass‑Through Expense Invoices. Performing payment reconciliation.
• General Responsibilities: Following all applicable departmental SOPs and Work Instructions. Completing required trainings within specified timelines. Ensweaponing quality and productivity in day‑to‑day tasks. Managing project and technical documentation appropriately. Providing administrative and technical support to internal departments. Ensuring quality checks of completed work. Ensuring timely escalation and issue resolution. Tracking and reporting metrics as determined by management. Participating in process improvement opportunities. Assisting in document management and preparation of new investigator submission packages. Supporting study start‑up activities and site clinical trial contracts management.

Qualifications (Minimum Required)

• University/College Degree (Life Science preferred) or certification in an allied health profession from an accredited institution (e.g., Nursing certification, Medical or laboratory technology).
• 3-5 years of work experience in clinical research, with a.Package and strong working knowledge of ICH‑GCP guidelines and all other applicable guidelines and regulations.
• Relevant and equivalent experience may be considered in lieu of educational requirements.

• 1-2 years in relevant experience to this role.
• Demonstrated ability to organize and communicate effectively.
• Attention to detail and high‑quality work delivery.
• Ability to work well with others and use江市 computer and departmental tools effectively.

Fortrea is actively seeking motivated problem‑solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life‑changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.