宁波招聘

To manage allocated study sites to ensure that timelines, recruitment and quality standards are met on all clinical trial projects and act in a lead role in a study. The key function includes:
-Monitor clinical trials according to Good Clinical Practice (GCP), BI Standard Operating Procedures (SOPs) requirements, Working Instructions (WIs) and procedures.
-Ensure that high quality data is generated and that the trial is being conducted at the investigator site in accordance with the trial protocol, SOP, GCP and local regulatory requirements.
-Assist Clinical Monitor Local (CML) in the implementation of trials to ensure the study timeline, budget and quality are met.

1) Study Preparation
-Identify and select qualified investigator sites
-Assist with the development of local documentation as required
-Collect essential pre-study documents (in accordance with GCP/SOPs/WIs)
-Ensure submission of all required document to Institutional Ethics Committees and Review Board (IEC/IRB) and Health Authorities (HA)
-Initiate centers after receipt of favourable opinion from IEC/IRB and HA
-Initiate Remote Data capture (RDC) verification for site
-Support contract negotiations with Investigators/Centers
-Assist with CML with project planning and logistics, including overview of budget, timeline, risk management, and etc.

2) Study Conduct
-Review Case Report Forms (CRF)/ electronically Case Report Forms (e-CRF) for accuracy, completeness and legibility
-Review source documents to verify data in CRFs/e-CRFs (e.g. informed consent signed and dated by both subject and investigator, concomitant diagnoses, concomitant medication, visit dates, eligibility for study, adverse events and serious adverse events)
-Reporting and follow-up of all adverse events in accordance with company and local regulatory guidelines.
-Follow instructions in Monitoring Manual and inform CML of any information requiring update including Protocol Violation (PV) logs, status update, and etc.
-Conduct & document all monitoring activities (on-site and telephone contact visits) and written correspondence (letter, fax, e-mail) in accordance with SOPs/WIs and where applicable as further defined by the study monitoring manual. Document site activity findings and points requiring follow-up in visit reports.
-Review drug dispensing and accountability records, maintained by the investigator. Monitor study supply levels at assigned sites to avoid “out of stock” situations. In addition review storage conditions and expiry dates on a regular basis.
-Track patient recruitment rate at each allocated site and take appropriate steps to achieve agreed targets.
-Ensure contents of Investigator Site File (ISF) of assigned sites are complete and current.
-Ensure appropriate documents are submitted into IDEA ( International Document management and Electronic Archiving system) in timely manner at site level
-Implement of Corrective Actions and preventive action system (CAPA) if appropriate
-Co-operate with the Data Management (DM) and CML to resolve with the investigator any data queries.
-Ensure that investigators fulfill their study contract, particularly with respect to timely recruitment, adequate data quality and adherence to protocol.
-Support activities related to payment to sites.
-Conduct Close-out and archiving activities in accordance with GCP/SOPs/WIs.
-Assist CML with project coordination with other team members
-Assist CML with additional responsibilities such as monitoring report review if appropriate

3) Effective Communication and Customer Focus
-Communicate effectively both verbally and in writing with investigators, other site staff and members of the Clinical
-Proactively participate in investigator or team meetings as required
-Build and enhance relationships with investigators, site staff and key opinion leaders on behalf of BI
-Provide site staff with training and advice on study related issues to support production of high quality documentation
-Take ownership of customer queries or complaints and seek timely resolution
-Present at meeting as required

4) Teamwork
-Provide clear guidelines and share information with investigators on study objectives and procedures to build their understanding of expectations and targets.
-Seek out and build competence in therapeutic knowledge, company products and technical aspects of studies through training by colleagues and exposure to different situations.
-Offer support to other team members to share best practice and help achieve team goals
-Coaching new CRAs as required
- Study site startup on time as planned GAUDI KPIs
-Ensure all essential site documents / set-up requirements in place
-Adherence to trial milestones
-Site visit and complete visit reports timely
-Manual PV logs management appropriately
- CAPA implement
- Optimization of performance


Per Health authority requirements

Bachelor degree or above, MD preferred, otherwise medical related specialty including pharmacy, nursing, medicine and other biological background is an asset

preferably at least 2 years prior experience in site monitoring

- Good knowledge of GCP and local clinical trial regulations
- Good knowledge of Monitoring Clinical Trials and Medical Terminology
- Good communication and interpersonal skills
- Basic computer skill (MS Office, Internet, etc)
- Ability and flexibility to travel locally and abroad

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