Senior Clinical Research Associate

Address
Haymarket 2000, Sydney, New South Wales

Description
                                                                                          
                  
                    
                    About the Position                  
                    
                    JOB LOCATION                    
                    
:  (Remote-based)                    
                    
JOB TITLE:                    
                    
Senior Clinical Research Associate                    
                    
JOB REPORTS TO:                    
                    
Team Lead, Monitoring&Site Management                    
                    
JOB DEPARTMENT/UNIT NAME:                    
                    
Clinical Services>Clinical Operations>Monitoring&Site Management                    
                    
JOB SUMMARY:                    
                    
Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale. In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices. In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.                    
                    
AREAS OF RESPONSIBILITY:                    
                    
Monitoring– Subject Expert                    
                    
Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.                    
                    
Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.                    
                    
When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.                    
                    
May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.                    
                    
Project Monitoring Lead                    
                    
May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.                    
                    
Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.                    
                    
Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues.                    
                    
Site Recruitment and Setup                    
                    
Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools.                    
                    
Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.                    
                    
Investigational Site Monitoring                    
                    
Primary clinical site contact.                    
                    
May act as primary contact for any questions or issues that arise from investigational sites.                    
                    
Oversee overall integrity of the study to promote positive working relationships with the site and staff.                    
                    
Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.                    
                    
Ensure all site related issues are followed until resolution.                    
                    
Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.                    
                    
QUALIFICATIONS:                    
                    
The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.                    
                    
The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results. Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results. Ability to engage in continuous learning and self-development. Ability to continually foster teamwork.                    
                    
Fluency in English is required as this role requires regular communication in English with clients and staff located in Canada, the United States, Europe, and Asia-Pac.                    
                    
WORKING CONDITIONS:                    
                    
Remote-based                    
                    
Significant travel (domestic)                    
                    
#LI-Remote                    
                    
Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to                    
                    
                    
                    
                    
                  
              
              
                no -- Principals only. Recruiters, please don’t contact this job advertiser.                
no -- Please, no phone calls about this job!                
no -- Reposting this message elsewhere is NOT OK.              
              

  • Placed or Updated:
  • Category: Education, Training
  • ID: 735707
  • Please complete the required fields.
  • 0views