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- Initiation Clinical Research Associate II/Senior
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Initiation Clinical Research Associate II/Senior
Parexel International Corporation
Hong Kong SAR
Job Description:
• 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 prequalification and qualification activities, which may include: Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
• 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:
- IRB/IEC and MoH / RA submission/approval,
- Site activation,
- 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 meetings, audits & regulatory inspections.
• Work in a self-driven capacity, with limited need for oversight.
• Proactively keep manager informed about work progress and any issues.QualificationsQualifications:
• 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.
• 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
• Able to accommodate travel time requirements, according to tasks allocation/phase of the study
assigned.
• Attention to detail.
Job posted: 2021-01-29