職位描述
*Job Description
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 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
Monitor and maintain ICH-GCP compliance
Responsible for the completeness and quality of the on-site files
Respond to site issue alerted from Clinical Monitoring Associate (i.e., non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
Collect SRP documents during QV and other 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
Collaborate with CMA on site issues/actions
Generate visit/contact report in accordance with monitoring plan
Code and scan Central File documents where applicable
Ship relevant wet-ink signature documents to the Assistant or back to the site
Escalate any issues that require immediate action to the Coordinator/GRO Lead
Inform responsible Coordinator of work status regularly
Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor
Attend audits / Regulatory Inspection if requested
Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and stud specific procedure
Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)
Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor
*Job Qualifications
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
Strong regulatory knowledge including GCP
Excellent interpersonal, verbal and written communication skills
Sound problem solving skills
Ability to successfully work in a (`virtual) team environment
Sound presentation skills
Consultative skills
Client focused approach to work with the ability to interact professionally within a client organization
Ability to prioritize multiple tasks and achieve project timelines
Able to take initiative and work independently
Sense of urgency in completing assigned tasks
Able to travel a minimum of 65% on average
Holds a driving license where required
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work
