Senior Clinical Research Associate-FSP

1 week ago

Shanghai, Shanghai, China Parexel Full time

Job Summary

Parexel is seeking a highly skilled and experienced Senior Clinical Research Associate - FSP 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.

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).
  • 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.
  • 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.

Accountabilities from Site Identification to Close out:

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.
  • 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.
  • 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.
  • 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.

Requirements:

  • Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.

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 decisions 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, 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.

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