The Initiation Clinical Research Associate II ( iCRA II ) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for...
The Initiation Clinical Research Associate II (iCRA II) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA II can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial.
This role can be based either office-based in Madrid or Barcelona or decentralized in Spain.
Key Accountabilities
Start-Up (from site identification through pre-initiation)
This role can be based either office-based in Madrid or Barcelona or decentralized in Spain.
Key Accountabilities
Start-Up (from site identification through pre-initiation)
- Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies for:
- IRB/IEC and MoH / RA submission/approval,
- Site activation,
- Patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS).
- Strong problem-solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Client focused approach to work.
- Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Fluent command of Spanish and English languages.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Excellent time management to meet study needs, team objectives, and department goals.
- Previous experience in study set up / site initiation / study start up experience or equivalent experience in clinical research environment, with understanding of clinical trials methodology and terminology, including experience with EU CTR.
- Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable.
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
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