Key Accountabilities
•； Assume the ability to meet the requirements of a CMA I with a high degree of proficiency and autonomy
•； Take responsibility for specific tasks on projects, or acts as the main CMA contact on individual projects
•； Train team members on selected tasks
•； Collaborate with CRA on site issues/actions
•； Create and distribute study document (e.g. eSignature Agreement, etc.)
•； Initial and ongoing drug / supply management
•； Responsible for the completeness and quality of the in-house site specific files
•； Track system access of PAREXEL team members
•； Update all relevant tracking system on an ongoing basis
•； Maintain team list and sponsor / vendor details
•； Perform regular reviews of data according to data review/monitoring guidelines (EDMS, CTMS, CDMS/EDC, IVRS)
•； Conduct remote visits (prequalification, qualification, initiation, monitoring, termination)
•； Collect regulatory documents in collaboration with CRA and CTS as needed
•； Primary in-house site support
•； On a regular basis conduct outbound and receive inbound calls to:
； Review recruitment plan and enrollment updates
； address/resolve issues pending from the previous visit
； address protocol questions
； check on site staff assignment
； assess drug/study supply status
； request outstanding documents
； review site payment status
； follow-up on data entry, query status and SAEs
•； Follow-up on appropriate site related questions forwarded by helpdesk
•； Build relationships with investigators and site staff remotely
•； Keep manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor.


Skills
•； Strong computer skills including but not limited to the knowledge of a Clinical Trial Management Systems, PMED, EDC, IWRS, MS-Office products such as Excel, Word.
•； Strong awareness of all relevant regulations, including GCP
•； Ability to successfully work in a (‘virtual’) team environment
•； Strong knowledge of clinical research process
•； Analytical skills
•； Sound interpersonal, oral and written communication skills
•； Sound problem solving skills
•； Strong customer focus, ability to interact professionally within a client organization
•； Ability to prioritize multiple tasks and achieve project timelines
•； Sense of urgency in completing assigned tasks
•； Attention to detail
•； Effective time management in order to meet daily metrics or team objectives
•； Shows commitment to and performs consistently high quality work.
•； Effectively applies knowledge to provide advice or solutions based on expertise
•； Offers support and constructive feedback to project team members
•； Seeks opportunities to develop experience and knowledge
•； Must be able to work independently but seek guidance when necessary, escalating issues as required
•； Willing and able to travel as required – local or international


Education
•； Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience

Language Skills
•； Competent in written and oral English and relevant local languages

Minimum Work Experience
•； Previous CMA, clinical, data management and/ or research experience with solid understanding of clinical trials methodology and terminology

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