Sr Initiation Clinical Research Associate (Study Start Up Specialist)

Parexel strives to be the premier provider to the biopharmaceutical and medical device industries for the development and commercialization of new medical therapies worldwide. Our mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease.

This role can be either office-based in Berlin or decentralised in Germany.

The Senior Initiation Clinical Research Associate (Sr iCRA) 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 Sr 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.QualificationsEducation:

- 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:

- 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.

- Excellent interpersonal, verbal, and written communication skills.

- Fluent command of German and English (written and oral).

- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.

- Excellent time management in order to meet study needs, team objectives, and department goals.

- Shows commitment to and performs consistently high quality work.

- 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.

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