Initiation Clinical Research Associate II~Senior (SSU)

Parexel International Corporation

South Korea - Any Region - Home Based

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.QualificationsSkills:

• 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.

• 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.

• Strong ability to make appropriate decisions in ambiguous situations.

• 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.

• 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.

• Proven 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.

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

assigned.

• Act as a mentor and role model for other team members.

• Effectively enlist the support of team members in meeting goals.

• Attention to detail.

• Holds a driver’s license where required

Knowledge and Experience:

• Substantial 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

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2022-08-05 00:05:25

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