Essential Function

The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.

Key Accountabilities

• Assume the ability to meet the requirements of a CRAI with a high degree of proficiency and autonomy.
• Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects.
• Train team members on selected tasks.
• Keep Manager informed about work progress and any issues to avoid surprised. Requires some interaction / supervision by Manager or assigned mentor.
• Build relationships with client, 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 Study Team (i.e. non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction).
• Collect Statutory Regulatory Package 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 systems on an ongoing basis.
• Collaborate with Study Team 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 Study Team.
• Attend audits / Regulatory Inspection if requested.
• Maintain a working knowledge of, and ensure compliance with, applicable ICH-GCP Guidelines, local Regulatory requirements and PAREXEL SOPs and study-specific procedures.
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)

Skills

• 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.
• Shows commitment to and performs consistently high quality work.
• Effective time management in order to meet daily metrics or team objectives.
• 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 and passport where required.

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 and fluent in relevant local language.

Minimum Work Experience

• Substantial monitoring experience in clinical research.

上班地址：普陀区