Senior Clinical Research Associate (Contractor)

Overview

Freelance Senior Clinical Research Associate role on an independent contractor basis for 6 to 12 months (period to be determined later), acting as Parexel's direct contact with assigned clinical trial sites.

What you'll do

• 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 sites with access to relevant study systems and ensure sites are compliant with project specific training requirements.
• Evaluate whether on-site staff assignment is still accurate and determine and implement corrective actions and follow-up, if necessary.
• Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
• Address, evaluate and 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, and determine and implement appropriate follow-up action.
• Actively participate in investigator and other external or internal meetings, audits and regulatory inspections as required.
• Collect, review, and approve (if applicable) updated or amended site documentation, including regulatory documents as applicable.
• Evaluate site recruitment plan in collaboration with site staff on an ongoing basis and provide strategy for improvements.
• Perform on-site visits, including Qualification and Initiation visits, and apply judgment and knowledge to independently resolve site issues, questions and concerns.
• Conduct remote visits and contacts as requested or needed, and generate visit or contact reports.
• 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 and manage test article and study supply, including supply, accountability and destruction or return status.
• Review and follow up on 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 or changes on study timelines, and communicate study issues requiring immediate action with a proposed strategy for resolution.
• Ensure timely and accurate completion of project goals and update of applicable trial management systems from site identification to close out.
• Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage support of team members where required.
• Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including 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 sites, including configuration of Investigator Site Files if applicable and ongoing 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 the Administrative Support Team as needed, guide team members, review their work, and provide feedback to manager regarding performance.
• Maintain a positive, results-oriented work environment, build partnerships and collaborative relationships, and model high performance culture values.
• Maintain working knowledge of and ensure compliance with ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel or Sponsor training requirements, and study specific procedures, plans and training.
• Ensure basic understanding of project scope, milestones and budgets, and strive for high quality, timely and efficient delivery.
• Provide input and feedback for Performance Development Conversations, and proactively keep manager informed about work progress and any issues.
• Develop expertise to become a subject matter expert, working in a self-driven capacity with limited need for oversight.
• Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics).

What you'll need

• Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
• CRA experience from Australia is required.
• Around or above 5 years of CRA experience.
• Educated to degree level in biological science, pharmacy, or other health-related discipline, or equivalent nursing qualification or other equivalent experience.
• Sound problem solving skills.
• Able to take initiative and work independently, and to proactively seek guidance when necessary.
• Advanced presentation skills.
• Client focused approach to work, and 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, using strong analytical skills to make decisions autonomously.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Strong computer skills, including 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 or country deliverables while preserving patient safety.
• Effective time management to meet study needs, team objectives, and department goals.
• Developing ability to work across cultures.
• Ability to work successfully in a virtual team environment.
• Great attention to detail.
• Ability to accommodate extensive travel time requirements, according to task allocation and phase of the study.
• Holds a driver's license where required.

Nice to have

• Oncology experience.
• Biological science, pharmacy, or other health-related degree preferred.

Details

• Location: Australia, remote. Preference for NSW and VIC; also open to SA and QLD candidates.
• Independent contractor role for 6 to 12 months (period to be determined later).