Clinical Research Associate

1 day ago

Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

Parexel Federal Territory of Kuala Lumpur, Malaysia

Clinical Research Associate - FSP

Parexel Federal Territory of Kuala Lumpur, Malaysia

Key Accountabilities:

Start-up (from site identification through pre-initiation):

  • 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, which may include:
  • Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
  • 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, collect, review and approve country/site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
  • Customize, review, and negotiate country/site specific Informed Consent Forms (ICF), translations, and any amendments.
  • Prepare and submit IRB/IEC and MoH/RA 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.
  • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
  • Identify and resolve site questions and/or issues, including potential issues or risks with site activation timelines, 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 compliance with all project specific training requirements prior to study start.
  • Participate in Investigator and other external or internal meetings, audits & regulatory inspections.
  • Work in a self-driven capacity, with limited need for oversight.
  • Keep manager informed about work progress and any issues.

Maintenance (from initiation through close out):

  • 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 with investigators and site staff.
  • Facilitate and support site with access to relevant study systems and ensure compliance with project specific training requirements.
  • Evaluate on-site staff assignments and implement corrective actions if necessary.
  • Address and resolve issues at sites, including training needs and documentation deficiencies.
  • Follow-up on site related questions and previous visit issues.
  • Identify and evaluate potential data quality and integrity issues and determine appropriate follow-up actions.
  • Participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
  • Collect, review, and approve updated/amended site documentation, including regulatory documents.
  • Evaluate site recruitment plans in collaboration with site staff and provide improvement strategies.
  • Perform on-site visits, including Qualification and Initiation visits; resolve site issues independently.
  • Conduct remote visits/contacts as requested/needed.
  • Generate visit/contact reports.
  • Evaluate compliance and performance of sites and site staff: provide recommendations regarding site-specific actions.
  • Manage test article/study supply including 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 assessments.
  • Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues requiring immediate action, with proposed strategies for resolution.

Overall 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 strategies for efficient project planning and goal completion, and encourage support among team members.
  • Update all appropriate Clinical Trial Management Systems (CTMS) regularly, ensuring timely and high-quality data entry compliance from sites, manage and submit relevant documents to the Trial Master File (TMF).
  • Ensure assigned sites are audit and inspection ready.
  • Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
  • Delegate administrative tasks to Administrative Support Team as needed, guide 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.
  • Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, and study-specific procedures.
  • Ensure basic understanding of project scope, milestones, budgets, and strive for high-quality, timely, and efficient delivery.
  • Provide input and feedback for Performance Development Conversations.
  • 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.)

Skills:

  • Able to work independently, seeking/taking guidance when necessary.
  • Sound 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 manage multiple tasks and achieve project timelines.
  • Willingness to work in a matrix environment and value teamwork.
  • Strong computer skills including knowledge of CTMS, EDMS, and MS-Office products.
  • Sound interpersonal, verbal, and written communication skills.
  • Sense of urgency in completing assigned tasks.
  • Developing ability for effective time management.
  • Developing ability to work across cultures.
  • Shows commitment to performing consistently high-quality work.
  • Able to accommodate travel time requirements.
  • Holds a driver's license where required.

Knowledge and Experience:

  • Previous relevant work experience preferred.
  • Site Management experience or equivalent experience in monitoring Oncology trials, with understanding of clinical trials methodology and terminology.

Education:

  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Science and Research
  • Pharmaceutical Manufacturing
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