Duties and Responsibilities (including but not limited to):

Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
Conduct study feasibility and site selection activities
Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
Assist with investigator meeting activities including organization, preparation and attendance
Conduct site management activities including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
Establish and maintain good rapport with study sites.
Write study visits reports and follow up letters within the timeline established by applicable SOPs and guidelines
Representation of CRAs during an audit or inspection when assigned
Coordinate timely shipment of clinical supplies and study drug to sites.
Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
Maintain adequate site tracking records
Follow up of drug safety issues and safety reports in timely manner, if applicable
Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead and Clinical Research Manager accordingly
Develop and implementation of corrective actions when appropriate
Assist with data query form (incl. query process)
Prepare /review all patients tracking records
Input and maintain study information concerning subject status of financial reimbursement to sites.
Conduct and assist with administrative activities as a member of the project team.


Education and Work Experience:

Bachelor’s Degree in allied health fields: Medical, Nursing, Pharmacy, Psychology, Veterinary or Health Science
Minimum of 1 year experience as a Clinical Research Associate
Knowledge, Skills, and Abilities:

Excellent verbal and written communication skills
Good verbal and written English language skills
Strong computer literacy e.g. MS word, Excel, PowerPoint, internet
Excellent organizational, record retention, and time management skills
Knowledge of ICH-GCP, applicable law (local and country) and regulatory requirements

其他信息
语言要求：英语、普通话

所属部门：KA