The Clinical Research Associate 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).

The Clinical Research Associate might be asked to complete tasks on behalf of the Clinical Operations Leader after receiving appropriate training.

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.

In Japan for studies that are using Parexel SOPs, prior to SIV the iCRA will be responsible for preparing the initial site related IRB application and associated documents required prior to SIV as delegated by CRA, and reviewing and approving all essential documents (SRP, ICF etc.). Post SIV the iCRA would review / approve the documents as determined by Parexel SOPs (e.g. SRP & ICF). For studies that use client SOPs, the necessity for the iCRA role will depend on the contracted tasks / procedures; if the iCRA role is not required the CRA will cover all tasks necessary.

Skills:

• Sound problem solving skills.

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

• Advance presentation skills.

• Client focused approach to work.

• Ability to interact professionally within a client organization.

• 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.

• Strong interpersonal, verbal, and written communication skills.

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

• Effective time management in order to meet study needs, team objectives, and department goals.

• Developing ability to work across cultures.

• Shows commitment to and performs consistently high-quality work.

• Ability to successfully work in a (‘virtual’) team environment.

• Consulting Skills

• Great attention to detail.

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

• Holds a driver’s license where required.

Knowledge and Experience:

• Site Management experience or equivalent experience in clinical research, with 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 or other equivalent experience