Initiation Clinical Research Associate

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Due to a growing portfolio, we are currently looking for Initiation Clinical Research Associate to be based in Sweden or Denmark.

The iCRA = Study Start-Up 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 can also support protocol amendments if applicable. This role involves performing all study start up activities for a clinical trial.

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

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:
- Fluent command of English (written and oral) in addition to the local language (Swedish /Danish, and Norwegian)

- 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.
  - 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.
  
  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!