Initiation Clinical Research Associate II

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 for an Initiation Clinical Research Associate (Study Start Up Specialist) for our Belgium Study Start up Department. Ideally you will have some previous study start up experience either working in another CRO or a Pharma organization, please apply if you are interested and have the relevant SSU experience. If you have previous clinical operations experience and are interested in a SSU role this may also be considered.

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

Essential Function:

The Initiation Clinical Research Associate (Study Start Up Specialist) 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:
- 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 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 relevant work experience in clinical research (Site Management experience or Start Up experience are preferred).
- Good knowledge of 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.

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!