SSU II ~ Sr. SSU (iCRA II ~ Sr. iCRA)

• 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

Skills:
• 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