iCRA II

Parexel International Corporation

Shanghai, Shanghai Municipality, China


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:

o Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.

o 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:

o IRB/IEC and MoH / RA submission/approval,

o Site activation,

o 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

• Work in a self-driven capacity, with limited need for oversight.

• Proactively keep manager informed about work progress and any issues.Qualifications• Problem solving skills

• Able to work independently, seeking/taking guidance when necessary.

• Sound presentation skills.

• Client focused approach to work.

• Ability to interact professionally within a client organization with the support of manager or CRAII/III

• Flexible attitude with respect to work assignments and new learning.

• Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).

• 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.

• Sound interpersonal, verbal, and written communication skills.

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

• Developing ability for 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.

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

• Attention to detail.

• Holds a driver’s license where required


2020-08-02 01:00:49


Apply to this job