Clinical Research Associate II
il y a 2 jours
Parexel is a leading global biopharmaceutical services company that provides a suite of services to help clients transform scientific discoveries into new treatments. We are currently seeking a Clinical Research Associate II to join our team in France.
Key Responsibilities:- 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.
- 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.
- 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.
- Ensure timely and accurate completion of project goals and update of applicable trial management systems.
- 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 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 that assigned sites are audit and inspection ready.
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
- 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 consistent high-quality work.
- Maintain a positive, results-oriented work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high-performance culture values.
- 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, milestones, budgets, and strive for high-quality, timely, and efficient delivery.
- Provide input and feedback for Performance Development Conversation(s).
- Proactively keep manager informed about work progress and any issues.
- Develop expertise to become a subject matter expert.
- Work in a self-driven capacity, with limited need for oversight.
- Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.).
- 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 decisions 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.
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
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