Senior Initiation Clinical Research Associate/ 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 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