職位描述
Key Accountabilities:
- Receive, track and inventory documents for central files. Ensure that documents required by team members are accessible. Obtain any missing/incomplete data from investigators in conjunction with CRAs and other study team members
- Ensure accuracy of coded documents for central files, perform document scanning when applicable
- Produce reliable up to date reports of patient/study status to ensure that clinical data input is up to date, accurate and complete
- Ensure the complete documentation and timely arrival of clinical supplies and study drugs for site visits in conjunction with CRAs and other study team members
- Assist CRAs and other study members as needed
- Ensure CRF pages are being processed, tracked and forwarded to Data Management on time
- Assist with telephone query resolution as needed
- Ensure the timely and accurate investigator payments in conjunction with CRAs and other study team members
- Participate in project meetings (taking minutes if appropriate), replace study team members on project team calls when necessary
- Have up to date knowledge on study procedures and study related materials
- Ensure work adheres to Good Clinical Practices, applicable regulatory and legal requirements, and PAREXEL Standard Operating Procedures (or clients’, according to exhibit) proactively flagging any issues to the appropriate CRA
- Serve as a resource for the project team or Clinical tam, depending on workload can be delegated to other project related tasks (e.g. set-up activities, other)
- Contribute to the smooth running of the department and departmental activities e.g. arranging meetings and travel
- Provide support to the study team
- Responsible for completeness, quality and accessibility of Central Files
- Supervise receipt, tracking and archiving of documents for Central Files
- Responsible for accuracy of coded documents for central files
- Provide Clinical Lead and the team with detailed information on study procedures and study related materials
- Development of Central File Maintenance Plans, CTMS-Data Entry Guidelines and other study specific plans, forms and templates in close cooperation with Clinical Lead
- Responsible for up to date reports of study status in CTMS or client equivalent
- Support Clinical Lead in the set-up and maintenance of systems
- Responsible for the timely arrival of clinical supplies and study drugs at the sites
- Responsible for timely and accurate investigator payments
- Organise project meetings and taking of minutes
- Ensure the smooth operation of the department and departmental activities
Benefits
Our success is built on recruiting the best available talent and providing exemplary benefits in an effort to develop long-term relationships. As a CPS employee, the following benefits are available to you:
- Highly competitive salaries
- Expense reimbursement
- Paid holidays, vacation, and other time off
- Work-life balance policy
- Excellent Benefits (tailored by country) including pension, health care, dental care, life insurance, etc
*Job Qualifications
Requirements:
- Excellent interpersonal, verbal and written communication skills
- Ability to communicate directly with study team members in an international environment
- Ability to communicate directly with Sponsor/other vendors
- A flexible attitude with respect to work assignments, new learning and travel
- Demonstrated ability to manage multiple and varied tasks with positive attitude, prioritize workload with attention to detail and within agreed timescales
- Willingness to work in a matrix environment and to value the importance of teamwork
- Demonstrated ability to work independently and use initiative to complete tasks
- IT literate – experience with Microsoft based applications and general knowledge of PC functions, especially knowledge of Excel
- Must be educated to minimum of high school diploma – ideally with a degree in life science, nursing qualification or similar
