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)
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).
Skills:
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.
Knowledge and Experience:
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.
Education:
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
If you are ready to join Parexel's Journey, please apply!
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