Initiation Clinical Research Associate

at  Parexel

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!

Please refer the Job description for details