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- Senior Initiation Clinical Research Associate/ Sr. ICRA
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Senior Initiation Clinical Research Associate/ Sr. ICRA
Parexel International Corporation
Seoul, Seoul, South Korea
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:
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.
• Work in a self-driven capacity, with limited need for oversight.
• Proactively keep manager informed about work progress and any issues.
• Build relationships with investigators and site staff.
• Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
• Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
• Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
• Address/evaluate/resolve issues pending from the previous visit, if any.
• Follow-up on and respond to appropriate site related questions.
• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
• Conduct remote visits/contacts as requested/needed.
• Generate visit/contact report.
• Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
• Assess & manage test article/study supply including supply, accountability and destruction/return status.
• Review & follow-up site payment status.
• Follow-up on CRF data entry, query status, and SAEs.
• Conduct on-site study-specific training (if applicable).
• Perform site facilities assessmentsQualificationsSound 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.
• Holds a driver’s license where required
Job posted: 2021-05-30