Clinical Research Associate II

2 weeks ago

Sydney, New South Wales, Australia Parexel Full time
Overview

Parexel North Ryde, New South Wales, Australia. Join to apply for the Clinical Research Associate II role at Parexel.

Responsibilities
  • 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 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.
  • Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
  • Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
  • 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 as requested/needed.
  • Generate visit/contact report.
  • Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and 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 assessments.
  • 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.
Knowledge And Experience
  • Site Management experience or equivalent experience in clinical research, 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
  • Mid-Senior level
Employment type
  • Full-time

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