Clinical Research Associate

1w1 week ago

Grifols

Dublin, IE · Full-time · €55,000 – €75,000

About this role

Join Grifols, a global healthcare company since 1909 improving health worldwide through plasma-derived medicines and transfusion medicine solutions in over 110 countries. Assist in clinical trial management to ensure timelines and metrics are met. Provide support in vendor oversight and clinical data review for regulatory, ICH GCP, SOP, and protocol adherence.

Manage the clinical monitoring process to confirm site compliance with regulations, ICH GCP Guidelines, company SOPs, and study protocols. Demonstrate good knowledge of the therapeutic area and product. Obtain complete understanding of trial-related documents and procedures with moderate direct supervision.

Work within an international team committed to diversity, which adds value to business, teams, and culture. Support audit/inspection responses and contribute to issue resolution from study centers, authorities, and IRBs/IECs. Oversee study centers for timely execution, quality data, subject well-being, and trial integrity.

Gain exposure to CRF development, IXRS set-up, central lab set-up, and vendor processes while capable of training others. Perform PSVs, SIVs, IMVs, COVs, and Sponsor Site Visits. Support CTM regulatory reviews, product complaints, and TMF resolutions with supervisor guidance.

Requirements

Good knowledge of the therapeutic area and product
Complete understanding of all trial-related documents and operational procedures with moderate direct supervision
Familiarity with ICH GCP Guidelines and regulatory requirements for clinical trials
Ability to conduct site monitoring visits including PSVs, SIVs, IMVs, and COVs
Experience reviewing clinical data for protocol and SOP compliance
Knowledge of clinical trial materials management and investigational product release processes
Proficiency in trial master file (TMF) reviews and audit preparation

Responsibilities

Assist in the management of the clinical monitoring process to ensure site adherence to regulatory requirements, ICH GCP Guidelines, company SOPs, and study protocols
Ensure timelines and metrics are met and maintained throughout the study
Oversee completion of Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs)
Perform Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process
Support effective and timely audit/inspection responses
Contribute to resolution of escalated issues from study centers, regulatory authorities, and IRBs/IECs
Provide support on regulatory document review and approval for investigational product release
Assist with expedited identification, retrieval, and review of study documents for site activation