Clinical Research Associate II w/Bulgarian language

Parexel is looking for a Clinical Research Associate II to be based in Serbia.

• Frequent travels to Bulgaria required

• Speaking or learning Bulgarian language required

The Clinical Research Associate (CRA) is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to initiation, the development of a robust patient recruitment strategy, setting up a system, assessing compliance with regulations and the site’s capability to comply with the study needs and recruitment expectations, and problem solving to address and resolve site issues.

This may include various tasks and roles within the CRA framework, contingent upon project phase and country demands, and complexity of the study. The Clinical Research Associate will oversee the conduct of the trial at designated sites, ensuring the rights and well-being of human subjects are protected, evaluating the quality and integrity of the reported data, evaluating the site efficacy of staff training and requiring retraining where necessary, developing strategy regarding patient recruitment, evaluating and building the relationship with the clinical site, using problem-solving to promote positive working relationships with the site and staff, and ensuring the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).

Where available an “initiation Clinical Research Associate“ (iCRA) specializing in Pre SIV activities will be assigned & accountable for managing and driving the strategy for the Pre SIV / startup tasks of the study. The iCRA) also support protocol amendments if applicable.

Skills:

• Able to take initiative and work independently, and to proactively seek guidance when necessary.

• Ability to interact professionally within a client organization.

• 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.

• 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.

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

• Developing ability to work across cultures.

• Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.

• Holds a driver’s license where required

Knowledge and Experience:

• Independent Site Management /Monitoring experience with strong understanding of clinical trials methodology and terminology

Education:

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification.