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Initiation Clinical Research Associate II

Wavre, Wallonia, Belgium Date posted 08/04/2020 Job ID 55100BR b

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.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

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 harmonious environment at Parexel contributes to our success; the great collaboration helps to achieve the goals as one team, and to keep positivity, interest and development alive."

Nicla – 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

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are hiring an Initiation CRA for our Belgium office. Candidates must have strong previous study start up experience, please apply below if you are interested and have the relevant SSU experience.

This role can be based at either our office in Wavre or have some part home working. The office we have is open planned, and you will be working in an innovative and collaborative environment.

Essential Function:

Initiation Clinical Research Associate conducts and facilitates specific start-up activities such as feasibility, site identification, pre- qualification, Site Regulatory Package (SRP) review and approval, Informed Consent (ICF) customization, IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.

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
- Work in a self-driven capacity, with limited need for oversight.
- Proactively keep manager informed about work progress and any issues.

Qualifications

Skills:
- Client focused approach to work.
- Ability to interact professionally with external customers.
- Ability to manage multiple and varied tasks with enthusiasm.
- Attention to detail.
- Willingness to work in a matrix and virtual team 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.
- Sound interpersonal, verbal, and written communication skills.
- Sound problem solving skills.
- Sense of urgency in completing assigned tasks.
- Effective time management in order to meet daily metrics, team objectives, and department goals.
- Developing ability to work across cultures.
- Ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs.
- Willing and able to travel locally and internationally occasionally as required.

Education:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred).

Language Skills:
- Proficient in written and oral English, French and Dutch languages.

Minimum Work Experience:
- Previous documented relevant work experience in clinical research (Site Management experience, Start Up experience).
- Advanced 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 (but not mandatory) working with both new studies and existing study amendments.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive base salary, as well as a benefits package including holiday per year, pension scheme as well as other leading edge benefits that you would expect with a company of this type.

If you are ready to join Parexel’s Journey, please apply!

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