Clinical Research Associate II

Overview

Parexel is seeking a highly skilled Clinical Research Associate II to join our team. As a key member of our site management team, you will be responsible for ensuring the successful execution of clinical trials at assigned sites.

• Start-up Phase: Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
• Build relationships: Build relationships with investigators and site staff.
• Conduct feasibility and qualification activities: Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include: preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
• Generate visit/contact reports: Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
• Develop strategy: 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 and negotiate documents: 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 applications: Prepare and submit IRB/IEC and MoH/RA application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
• Submit documentation to the trial master file: Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
• Forecast, develop, manage, and revise plans and strategies: Forecast, develop, manage, and revise plans and strategies for: IRB/IEC and MoH / RA submission/approval, site activation, patient recruitment & retention.
• Update and maintain CTMS: Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
• Identify and resolve site issues: 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 site access: 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.
• Participate in meetings and audits: Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
• Work independently: Work in a self-driven capacity, with limited need for oversight.
• Keep manager informed: Proactively keep manager informed about work progress and any issues.

• Act as Parexel's direct contact: Act as Parexel's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
• Build relationships: Build relationships with investigators and site staff.
• Facilitate and support site access: Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
• Evaluate site staff assignment: Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
• Address and resolve site issues: Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
• Follow-up on site related questions: Follow-up on and respond to appropriate site related questions.
• Apply working knowledge and judgment: Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
• Participate in meetings and audits: Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
• Collect, review, and approve site documentation: Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
• Evaluate site recruitment plan: Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
• Perform on-site visits: Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
• Conduct remote visits/contacts: Conduct remote visits/contacts as requested/needed.
• Generate visit/contact report: Generate visit/contact report.
• Evaluate overall compliance and performance: 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 and manage test article/study supply: Assess & manage test article/study supply including supply, accountability and destruction/return status.
• Review and follow-up site payment status: Review & follow-up site payment status.
• Follow-up on CRF data entry, query status, and SAEs: Follow-up on CRF data entry, query status, and SAEs.
• Conduct on-site study-specific training: Conduct on-site study-specific training (if applicable).
• Perform site facilities assessments: Perform site facilities assessments
• Recognize impact of study non-compliance: Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution

• Ensure timely and accurate completion of project goals: Ensure timely and accurate completion of project goals and update of applicable trial management systems.
• Work with team members: Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
• Update CTMS: Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
• Ensure sites are audit and inspection ready: Ensure that assigned sites are audit and inspection ready
• Monitor and maintain compliance: Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
• Delegate administrative tasks: Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
• Show commitment and perform high quality work: Show commitment and perform consistent high quality work.
• Maintain a positive work environment: Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
• Maintain knowledge and compliance: Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
• Ensure basic understanding of project scope: Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
• Provide input and feedback: Provide input and feedback for Performance Development Conversation(s).
• Keep manager informed: Proactively keep manager informed about work progress and any issues.
• Develop expertise: Develop expertise to become a subject matter expert.
• Work independently: Work in a self-driven capacity, with limited need for oversight.
• Complete additional tasks: Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

• Problem solving skills: Sound problem solving skills.
• Initiative and independence: Able to take initiative and work independently, and to proactively seek guidance when necessary.
• Presentation skills: Advance presentation skills.
• Client focused approach: Client focused approach to work.
• Interpersonal skills: Ability to interact professionally within a client organization.
• Flexible attitude: Flexible attitude with respect to work assignments and new learning.
• Prioritization and decision making: 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.
• Teamwork: Willingness to work in a matrix environment and to value the importance of teamwork.
• Computer skills: 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.
• Communication skills: Strong interpersonal, verbal, and written communication skills.
• Sense of urgency: Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
• Time management: Effective time management in order to meet study needs, team objectives, and department goals.
• Cultural awareness: Developing ability to work across cultures.
• Commitment to quality: Shows commitment to and performs consistently high quality work.
• Virtual team environment: Ability to successfully work in a ('virtual') team environment.
• Consulting skills: Consulting Skills
• Travel requirements: Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
• Attention to detail: Attention to detail.
• Driver's license: Holds a driver's license where required

• Site Management experience: Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

• Degree level: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience