Initiation Clinical Research Associate II / Study Start-Up
Parexel International Corporation
Spain - Any Region - Home Based
We are hiring an Initiation Clinical Research Associate II for our Madrid office. Candidates must have strong previous study start up experience.
The Initiation Clinical Research Associate II role depending on level of experience, specialises in Pre SIV activities will be assigned and accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The Senior iCRA can also support protocol amendments if applicable.
Your 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) in a timely manner.
Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.QualificationsKey requirements: Life Science degreeAdvanced level study set up, site initiation, or study start up experience or equivalent clinical operations experience working in a clinical research environment, with a good understanding of both clinical trials methodology and terminology.Understanding and knowledge of Clinical Site Agreement (CSA) and site contracts experience is desirable working with both new studies and existing study amendments.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.Fluent EnglishStrong 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.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.Proven ability to work across cultures.Excellent presentation skills.