職位描述
Key Accountabilities
Consistently meet the requirements of a CRA II with a high degree of proficiency and autonomy:
？ Build relationships with investigators and site staff
？ Act as PAREXEL’s direct contact with assigned clinical sites, use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
？ 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; apply judgment and knowledge to independently resolve site issues, questions and concerns
？ Ascertain and recommend appropriate follow-up response to issues at clinical sites including potential deficiencies in documentation, communication, and the need for additional training
？ Conduct remote visits as requested/needed
？ Conduct on-site study-specific training (if applicable)
？ Perform site facilities inspection
？ Monitor patient safety on-site and address protocol violations and immediately provide report and recommendations to the Functional Lead (FL)
？ Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff
？ Monitor and maintain ICH-GCP compliance
？ Monitor and maintain completeness and quality of the on-site files
？ Respond to site issues as alerted to and identified by the Clinical Monitoring Associate (CMA) (i.e. non-responsive site, Protocol Deviations concerns, quality issues, and other items that require face to face interaction)
？ Collect Site Regulatory Package (SRP) documents during the Qualification Visit (QV) and other visits as needed
？ Establish site recruitment plan in collaboration with the site staff during QV; follow up and update recruitment at the Initiation Visit and Monitoring Visit
？ Collaborate with and communicate with the CMA on site issues/actions prior to planned visits and during the course of the trial
？ Apply working knowledge and judgment to identify and evaluate potential data quality issues. Determine and implement appropriate follow-up response
？ Generate visit/contact report in accordance with monitoring plan
？ Manage and process Central File documents in accordance with company policy
？ Ship relevant wet-ink signature documents to the Research Operations Assistant/Record Management Assistant or back to the site
？ Attend audits/Regulatory Inspection if requested
？ Maintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
？ Complete routine departmental administrative tasks in a timely manner (e.g. timesheets, metrics, etc.)
Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacities)
？ Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements and study specific procedures and training
？ Ensure basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery
？ Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files as per Central File Maintenance Plan
？ Escalate any site and study issues that require immediate action to the Functional Lead
？ Work with team members to meet project goals and encourage the support of team members where required
？ Delegate administrative and other tasks to ROAs as needed. Guide and mentor ROA, review work, and provide feedback to manager regarding performance.
？ Show commitment and perform consistent high quality work.
*Job Qualifications
Skills
？ Advanced presentation skills
？ Client focused approach to work
？ Ability to interact professionally within a client organization
？ A flexible attitude with respect to work assignments and new learning
？ Ability to prioritize multiple tasks and achieve project timelines, utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of the issues that arise.
？ Willingness to work in a matrix environment and to value the importance of teamwork
？ Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System, Electronic Documents Management System, EDC, IWRS, and MS-Office products such as Excel and Word
？ Excellent interpersonal, verbal, and written communication skills
？ Advanced ability to solve problems by using a logical, systematic, and sequential approach
？ Sense of urgency in completing assigned tasks
Effective time management in order to meet daily metrics, team objectives, and department goals
？ Able to take initiative and work independently
？ Shows commitment to and performs consistently high quality work
？ Ability to successfully work in a (‘virtual’) team environment
？ Consulting skills
？ Able to travel a minimum of 65% of time/month on average
？ Holds a driver’s license 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
？ Advanced written and oral English and fluent in relevant local language
Minimum Work Experience
？ Monitoring experience or equal experience in clinical research
