Clinical Research Associate

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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 within the CRA framework, contingent upon project phase, country demands, and study complexity. 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 applicable regulatory requirements.

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 and accountable for managing and driving the strategy for the Pre SIV / startup tasks of the study. The iCRA also supports protocol amendments if applicable. In Japan, for studies 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 using client SOPs, the necessity for the iCRA role depends on contracted tasks; 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.
• Advanced 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; using analytical skills to make autonomous decisions due to the unpredictable nature of issues that arise.
• Willingness to work in a matrix environment and to value teamwork.
• Strong computer skills including CTMS, EDMS, and MS-Office (Excel, 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 preserve patient safety.
• Effective time management to meet study needs, team objectives, and department goals.
• Ability to work across cultures and in a virtual team environment.
• Consulting skills and 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.

• Entry level

• Full-time

• Research, Analyst, and Information Technology

• Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care