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In-House Clinical Research Associate (FSP)

Spain - Any Region - Home Based Date posted 11/23/2021 Job ID 76926BR

Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction.

As a CRA at Parexel, you‘ll be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter—people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Innovative
  • Problem-Solver
  • Communicator
  • Tech-Savvy
  • Confident
  • Independent
  • "The last 4.5 years I had a steep learning curve and I am still learning via on-the-job challenges and solid management feedback. Next to my personal growth, I also enjoy our open atmosphere and the great collegiality."

    Stefanie – Sr Clinical Research Associate

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Compensation

    Competitive salaries and bonus structure based on individual metrics.

Responsibilities

This “in-house” CRA position is responsible for supporting study and site management activities and may include coordination, administration, or management of specific trial activities. An In House CRA may also be responsible for a management of some Client clinical trial sites. This role focuses on performing all activities required to evaluate, initiate, monitor and close clinical trial sites.
Organizational Relationships:
• Reports to ExecuPharm Line Manager with day-to-day direction from the Client.
• Liaises with cross functional lines as appropriate.
Primary Duties:
• Assist, or may lead Clinical Trial Management effort to develop, review and track study documents, including, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals.
• Ensure the Clinical Trial Master System (CTMS) and Trial Master File (TMF) are maintained in an inspection-ready state. Review for compliance and address findings as needed.
• Track site and study status as assigned.
• Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH.
• Train clinical investigators and their personnel in regard to clinical trial protocol and regulatory requirement.
• Collect and review site essential documents, including site Informed Consent Form (ICF) changes
• Act as a primary contact with field CRAs, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites.
• Monitor compliance with the clinical trial protocol, CFR, GCP/ICH guidelines, and overall protocol objectives.
• Assist with management and accountability of clinical trial supplies, including Investigational Product, research specimen samples and/or radiology scans
• Assist with management of clinical trial safety and efficacy issues, including, but not limited to:
review and follow-up of Serious Adverse Event reports.
• Perform data listings review and generate of data queries
• Assist in the preparation and follow-up of in-house and on-site Client sponsored quality audits, as well as, regulatory authority inspections.
• Conduct clinical team meetings, including agenda preparation, minutes, and action item tracking as assigned
• Ensure appropriate CRF completion and review and approval of clinical trial site monitoring reports
• Assist with the review and analysis of clinical data for clinical trial report generation.
• Assist with review, approval and reconcilition of clinical trial related invoices
• Actively contribute to process improvement
• Demonstrate increased ability to discuss scientific, medical and therapeutic area information.
• May conduct clinical trial site co-monitoring and independent monitoring visits including: Pre-study,
Initiation, Interim Monitoring, and Close-out visits. Follow all outstanding site issues to resolution and/or document attempts to resolve issues upon closure of clinical trial sites.
• May act as Protocol Lead for small clinical trial, geographical region of large clinical trial, or close-out
phase of any clinical trial study
• Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, Training Guides and other applicable guidelines.
• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
• Adheres to EP and Client SOPs and processes

Qualifications

BA/BS or equivalent or any relevant and qualifying training with a minimum of 4 years of relevant
clinical trial management experience.
• Knowledge of CFR and GCP/ICH requirements is required,
• Experience on Global Clinical Trials is preferred.
• Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint (preferred)
• Requires effective organizational and time management skills.
• Able to multi-task under limited direction and on own initiative.
• Strong communication and inter-personal skills
• Highly responsive and proactive, a team player
• Travel up to approx. 20% may be required

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