Senior Clinical Research Associate - Core Team

Parexel; Australia; On-site; AUD 90,000 - 130,000; Full time

Job summary

Parexel is seeking an experienced Clinical Research Associate (CRA) based in Australia for oncology trials. The role involves acting as the main Parexel contact at clinical sites, ensuring protocol adherence and high data quality across CTMS/EDMS systems.

Open to candidates in Melbourne, Sydney, Brisbane, or Adelaide with 4+ years of CRA experience from AUS or NZ. Travel to sites will be required as part of site visits and audits.

Qualifications

• Site management or clinical research experience preferred.
• Oncology trial experience is required.
• Experience within AUS or NZ is required.

Responsibilities

• Act as direct Parexel contact with sites and ensure protocol adherence.
• Build investigator/site staff relationships and support site training.
• Evaluate and implement corrective actions for site issues.
• Participate in audits and inspections as required.
• Manage CTMS/EDMS data entry and TMF documents.
• Monitor site recruitment plans and provide improvement strategies.
• Conduct on-site and remote visits and generate visit reports.
• Ensure regulatory documents and site documentation are up to date.

Skills

Problem solving

Initiative

Presentation skills

Client focus

Cross-cultural teamwork

Time management

Independent work

Travel readiness

Education

University degree in biology/pharmacy or health field

Tools

CTMS

EDMS

MS Office

Job description

• Open to consider experienced CRAs based in Melbourne, Sydney, Brisbane, or Adelaide.
• At least 4+ years of CRA experience from AUS or NZ with oncology trial experience is required.

Key Accountabilities

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 use judgment and experience to 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

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 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-orientated 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.)

Skills

• 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 decision 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 and preserving patient safety.
• 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
• Great attention to detail.
• Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
• Holds a driver’s license where required.

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