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 in office 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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📌 Clinical Research Associate II
🏢 Parexel
📍 Sydney