Title: Clinical Trial Assistant
Department: China Clinical Development
Reports to: Head of Clinical Operation and Innovation
Date: 1 May 2019
Summary:Clinical Trial Assistant is responsible for providing operational support for clinical trials
Provides technical support and administrative support to study teams.
Organizes study-related meetings including investigator meetings and study team meetings. Supports project managers with meeting materials and meeting minutes.
Supports administrative meetings including department meetings.
Supports project managers with study budget forecast and tracks study budget regularly.
Maintains study documents to ensure the quality of the (e)TMF according to regulatory requirements and SOPs/WIs of BriiBio.
Provides support for any study audits and inspections.
Maintains study trackers and logs, such as Q&A Log and Issue & action Log and ensures to distribute them to study team in time.
Supports project managers with vendor selection and management, e.g. RFP review, performance oversight.
Helps design and edit study newsletter.
Supports study teams with ordering/tracking/mailing of necessary trial supplies including thermometers, cabinets and any other equipment.
Supports study teams to coordinate internal and external suppliers to ensure customs clearance and import of all clinical trial supplies (including drug supply).
Coordinates relabeling of IMP at warehouse and drug destruction.
Tracks, processes and submits invoices of sites and vendors.
Processes and releases payments to vendors/sites in collaboration with study team and finance department.
Supports HGRAC application and CDE registration.
Education (minimum/desirable): Bachelor’s degree or above
Languages: Fluent Chinese and English both in spoken and written
At least 1 year working experience in Clinical Operation Function.
Problem Solving--Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Reasons when dealing with emotional issues.
Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Communication--Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs.
Leadership--Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Ethics--Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Strategic Thinking--Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
Judgment--Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Initiative--Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Innovation--Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.