職位描述
Key Accountabilities
? Build relationships with investigators and site staff
? Participate in Investigator and other external or internal meetings as required
? Arrange on-site visits and logistics (e.g. travel arrangements)
? Perform on site visits and generate visit/contact reports in accordance with the monitoring plan
? Conduct on-site study-specific training (if applicable)
? Perform site facilities inspection
? Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
? Responsible for the completeness and quality of the on-site files
? Respond to site issues alerted by the project team (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
? Collect SRP documents during site visits as needed
? Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
? Update all relevant tracking system on an ongoing basis
? Code and scan Central File documents where applicable
? Ship relevant wet-ink signature documents to the Assistant or back to the site
? Monitor and maintain compliance with ICH-GCP Guidelines, local regulatory requirements, PAREXEL and/or Client SOPs, and study specific procedures
? Escalate any issues that require immediate action to the CRA Coordinator or COL
? Attend audits / Regulatory Inspection if requested
? Inform responsible CRA Coordinator/COL/Manager of work status regularly
? Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)
? Recognize out of scope activities, escalate and communicate to the COL
? Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects
? Perform co-monitoring visits with less experienced CRAs or at problem sites as required
? Function as mentor and role model for less experienced CRAs and/or team members to ensure study specific training
? If applicable, act as an independent CRA Coordinator or COL coordinating a small to moderate team or multiple small size protocols
? If acting as CRA Coordinator or COL, represent function in external client meetings and presentations such as investigator meetings and bid defenses as required. May represent PAREXEL at professional meetings / conferences
? If acting as CRA Coordinator or COL, participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
Skills
? Strong regulatory knowledge including GCP
? Client-focused approach to work, with the ability to interact professionally within a client organization
? Ability to successfully work in a (‘virtual’) team environment
? Excellent interpersonal, verbal and written communication skills
? Effective time management in order to meet daily metrics or team objectives
? A flexible attitude with respect to work assignments and new learning
? Able to take initiative and work independently
? Sense of urgency in completing assigned tasks
? Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail to achieve project milestones
? Show commitment to and perform consistently high quality work
? Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word.
? Sound presentation skills
? Consultative skills
? Ability to solve problems through win-win solutions by using a logical, systematic, sequential approach.
? Able to travel a minimum of 65% on average
? Holds a driving license where required
? If acting as CRA Coordinator or COL:
o Give others appropriate latitude to make decisions
o Carefully weigh the priority of project tasks and directs team accordingly
o Ability to make appropriate decisions in ambiguous situations
o Ability to lead a “virtual”, global team as required
o Understand the strengths and development areas of team members
o Enlist the support of team members in meetings goals
Education
? Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
Language Skills
? Competent in written and oral English
Minimum Work Experience
? Adequate monitoring experience or equal experience in clinical research
