Responsibility主要职责

·         Be responsible for the delivery of the
studies at allocated sites and works in close collaboration with other CRAs
and the local study team to ensure that quality commitments are achieved in a
timely and efficient manner. 

·         Conduct site feasibility assessment.

·         Contribute to the selection of potential investigators
and leading investigator.

·         Contribute to national Investigator meeting.

·         Obtain and maintain essential documentation in compliance
with international guidelines ICH-GCP, Company procedural documents and local
regulations both in the office and at site.

·         Actively participate in local Study Team meetings. Share
information on patient recruitment and study site progress within local Study
Team. Good knowledge in relevant Therapeutic area to train, support and
advice Investigators and site staff in study related matters.

·         Initiate monitor and close study sites in compliance with
Company procedural Documents.  Ensures compliance with protocols, regulatory
requirements, and good clinical practices; writes follow-up visit reports.

·         Drive performance at the sites.

·         Update study related systems with data from sites per
required timelines.

·         Manage study supplies, drug supplies and drug
accountability at study sites.

·         Perform source data verification. Proactively identify
study-related issues and escalates as appropriate.

·         Complete monitoring visit reports within required
timelines. Document the issues and follow up with sites until it is resolved.

·         Ensure accurate and timely reporting of Serious Adverse
Events.

·         Work with data management to ensure quality of the study
data. Ensure data query resolution.

·         Prepare for activities associated with audit and
regulatory inspection at responsible sites and/country in liaison with local
study team lead and QA.

·         Ensure compliance with company policies and
procedures relating to people, finance, technology, security and SHE (Safety,
Health and Environment).

·         Ability to understand the impact of
technology on projects and to use and develop computer skills while making
appropriate use of systems/software

·         Responsible for completeness and
timeliness of the eTMF to maintain it “Inspection Ready”.

·         Identify and report quality
issues along with corrective and preventive actions to Local study leader/equivalent
esp when its related to any data privacy, serious breaches and/impact to the
reputation of company and safeguard patients’ rights and wellbeing.

Requirement任职要求

• Good
  medical knowledge and basic understanding of the drug development process.
• Fluent knowledge
  of spoken, read and written English.

·         Team oriented and flexible. Ability to manage
& prioritize multiple tasks with conflicting deadlinesAbility to work in an
environment of remote collaborators

·         Meticulous and detail-oriented

• Ability
  to travel nationally as required.