職位描述
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職位職能:
??臨床研究員??
職位描述:
Description
Study Planning/set-up activities
§ When required, assist LTM to conduct site feasibility
§ conduct Pre-trial visits to assess the investigational staff and facilities
§ Discuss the items listed on the PAR with the investigator and other appropriate staff
§ Review the site commitment in detail with the investigator
§ Develop/adapt recruitment and retention strategy for the site
§ Ensure all required trial-related materials and supplies are provided to the investigational site
§ Ensure that the investigators send the SUA gap pack to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
§ Set up the IF and TCF
§ If needed, development of site-specific ICF
§ Ensure that the investigational staff are instructed on the requirements for proper informed consent
§ When local Ethics Committees are used, ensure that the IEC/IRB is provided with current and complete copies of all documents that the IEC/IRB requests to fulfill its obligation and obtain a copy of the valid written IEC/IRB approval and all related required documents, including the composition of the IEC/IRB
§ Obtain site related trial documents and review them for completeness and accuracy
§ Negotiate investigator budgets at site level and track the status of site CTA
§ Plan and conduct investigator and site-staff training
§ Conduct site initiation visits
§ If applicable, execute the user acceptance testing plan
§ If applicable, create site specific and monitoring tools
Monitoring activities
§ Notify the GTM and the Local CSC in writing, when a country and an investigational site is approved to receive clinical drug supplies
§ At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored (e g , temperature logs, security), and returned, accurately inventoried and documented. Inform the investigational staff of the distribution process
§ Conduct monitoring visits according to the checklist of activities listed on the Monitoring Visit Report
§ Report to LTM on study site status through monitoring report and meetings
§ Document all study related communications
§ Perform SDV to ensure accurate data is recorded based if required
§ Follow up with the trial site(s) regarding completion of case report forms and data correction forms within required timeframe
§ Ensure that all AEs/SAEs/PQCs are reported within reporting timelines and documented as appropriate. For AEs/SAEs ensure they are consistent with all data collected and with the information in the source documents
§ Ensure that the investigators send the safety reports to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
§ Arrange for the appropriate destruction of clinical drug supplies
§ Ensure that the investigational staff stores the randomization codes in a limited access area that is accessible 24 hours a day and instruct them on the code-breaking procedure
§ In studies where IVRS/EDC are used, ensure that the IVRS/EDC at the site work smoothly during the study.
§ Track costs at site level and ensure payments are made with planned payment schedule
§ Ensure TCF is maintained as required and maintain IF
§ Ensure subject commitment per site is met
§ Conduct site closure visit according to the checklist activities listed on the site closure report
§ If applicable, remind the investigator to notify the IEC/IRB of the site closure
§ Ensure the IF is complete and accurate
§ Provide study report synopsis to investigators, IEC/IRBs
§ Check the Site details on Appendix 1 documents and provide feedback to the LTM
§ Follow up on and resolve any pending issues, including adverse events and IFDFs one year post-trial
General activities
§ Represent the company and the organization adequately to the customers and other external parties
§ Base all actions on Credo
§ Protect the rights of others, protect privacy and company assets, particularly information as the key asset
§ Conduct business in line with the HCC, company policies and procedures, including applicable SOPs, always having the ethical aspect in mind
§ Maintain adequate communication with relevant parties within and outside the company
§ Comply with ICH-GCP and all applicable local laws and regulations
§ Actively follow trainings to ensure adequate qualification for performing job-related tasks
§ Report (suspicion of) fraud or scientific/ethical misconduct as appropriate
§ Regularly update information in applicable systems and templates
§ Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company\'s effort towards continuous quality improvement
§ Maintain quality standards and timelines that are consistent with business needs
Qualifications
A. Education /Training background:
Bachelor degree, background of medicine or pharmacy is preferred
B. Knowledge/Skills:
Well familiar with ICH GCP, GCP of China and applicable regulations
Well familiar with procedures of clinical R&D and regulation application
C. Job experience:
3 years clinical study experience.
Working experience in international pharmaceuticals or CRO
D. Competency:
Good communication, team working, problem identifying and solving abilities
E. Others:
Good english ablities of listening, speaking, reading and writing; same level of CET-6 or above
