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- Initiation Clinical Research Associate II
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Initiation Clinical Research Associate II
Parexel International Corporation
Wavre, Walloon Brabant, Belgium
The Initiation Clinical Research Associate (iCRA) 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 I can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial.
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.
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conduct remote Qualification Visits (QVs).
- 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).
Education:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
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.
- Good previous Clinical Site Agreement (CSA) and site contracts experience is desirable
Skills:
- Strong problem-solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Excellent presentation skills.
- Client focused approach to work.
- Flexible attitude with respect to work assignments and new learning.
- 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.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- 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.
- Excellent interpersonal, verbal, and written communication skills.
- Fluent command of Polish and English (written and oral) is a must.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Excellent time management in order to meet study needs, team objectives, and department goals.
- Shows commitment to and performs consistently high quality work.
- Ability to successfully work in a (‘virtual’) team environment.
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
- Attention to detail.
If you are ready to join Parexel’s Journey, please apply!
Job posted: 2023-02-18