Senior CRA-SMA-Shanghai-00000ML1
Description
1. Principle Duties and Responsibilities (General summary, essential functions and authorities, etc.)
主要工作职责（基本概况，主要功能，权限等）
General Summary（基本概况）
The overall purpose of the position is specified as follows,
- Ensure clinical trial to be conducted in compliance with ICH GCP/SOPs, local regulations and protocols
- Ensure any adverse events known from clinical trials to be reported properly
- May work as a 'leader CRA' or 'project leader' on appropriate projects.
- Ensure project execution according to timeline and budget
- Develop and maintain working relationships with others requiring interaction and mutual support
- Provide guidance and coaching to less experienced CRAs and assist in their development and training.
Responsibility(工作职责)
Site Monitoring and Management:
1) Act as the main contact between sponsor and investigator site staffs.
2) Propose the potential investigational sites to project leader for a specific study. Verify the quality of the investigator and the suitability of the sites by performing study feasibility or site evaluation visit if necessary to ensure the site is qualified and suitable to conduct the study. Provide site evaluation report to project leader;
3) Ensure the smooth negotiation process on the site contract sign-off. Be responsible for site payment is properly paid according to the agreement.
4) Be involved in the preparation of the documentation for submission to EC.
5) Ensure the study is performed only after the EC approval is obtained.
6) Perform initiation, regular monitoring and close out visit to investigator site in compliance with study monitoring plan, company SOPs, local regulations and ICH GCP on budget and timeline. Prepare and submit accurate and timely site visit reports for all performed visits.
7) Manage study activities at assigned investigational sites. Discuss any issue identified and support the study sties staff as required.
8) Ensure that Investigators are aware of their responsibilities and the need to comply with company procedures, local regulations and ICH GCP.
9) Keep close follow-up on subject enrollment and protocol compliance at site to ensure the enrollment speed is aligned with planned and study implementation at site is in compliance with protocol, SOPs, relative regulations and ICH GCP.
10) Document and archive all clinical trial relevant activities;
11) Keep and maintenance the ISF and TMF to ensure it is update, complete and accurate according to SOPs, relative regulations and ICH GCP.
12) Verify the accuracy, completeness and legibility of the data collected in the studies;
13) Ensure all case report forms can be collected and queries can be resolved in a timely manner;
14) Verify the trial supply is stored, transferred, and tracked appropriately. And unused Investigational product and other study supplies is returned or destroyed at site properly after the completion of study.
15) Provide regular study updates to the project leader and update tracking tools utilized as appropriate.
16) Participate in project team meetings and provides feedback and suggestions for a successful completion of the project.
17) Prepare and participate investigator meeting as directed by the project leader.
18) Assist in the preparation for the internal or external audit/inspection. Resolve issues cited in audit reports.
19) To take on any other task as assigned by line-manager/project leader.
Project Management
1) Set up and lead the project team to ensure the study is implemented according to company policy, SOP and relative regulations.
2) Lead the project team to accomplish the proposed timeline;
3) Communicate with internal and external customers in terms of project progress and outstanding issues;
4) Lead the protocol design and approval process, provide scientific and feasibility input on the protocol and other study documents design;
5) Evaluate the potential investigational sites for a specific study in terms of the quality of the investigator and the suitability of the sites;
6) Prepare study budget proposal based on fair market value. Ensure the study is operated according to the budget
7) Actively guide and coach CRAs in the study team;
8) Coordinate with data management, statistician and medical writer to generate the statistical report and study report;
9) Evaluate the CRO, provide evaluation assessment to line manager;
10) Perform co-monitoring to team members.
11) Assess the training need of team members and assist in their development.
12) Assist in interviewing/recruiting new team members.
Technical / Professional Knowledge Input:
1) As project leader, provide feasibility assessment and input at project planning stage based on a satisfactory level of technical and professional skill or knowledge in position-related areas;
Relationship Building:
1) Build up and maintain healthy relationships with internal and external customers via smooth and efficient communications through the clinical studies
2) As project leader, support the team member to build up and maintain good relationships with study sites and internal customers..
Vendor Management:
1) As project leader, perform vendor selection and continuous quality and compliance tracking and evaluation.
2) As project leader, perform effective vendor management to ensure the services vendor provided are satisfied and qualified in compliance with J&J policy, SOP and other related requirements.
Other responsibilities defined in written procedures.（流程中规定的其它职责）
Principal Relations （inside ＆outside company）主要工作关系(公司内部和外部)
- Clinical research team in JJMC, regional, global and source companies;
- Medical affairs team in JJMC, regional, global and source companies
- Regulatory affairs team in JJMC, regional, global and source companies
- Clinical Quality Control/Assurance team in JJMC, regional, global and source companies
- Franchise marketing and leadership team;
- Finance business partners
- HCC and legal business partners
- Key opinion leaders and investigators
- SFDA technical reviewers
Qualifications
1. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）
Personal Requirements ( include experience, knowledge，skills and education)
个人背景要求（包括经验，知识，技能和教育背景）
- Bachelor's degree & above, clinical medicine would be preferred.
- At least 2 years experience in clinical research execution, including at least 1 year project management experience.
- Strong people communication skill.
- Project management skill (e.g. good planning, implementation and follow up) is required.
- Fluent in English speaking, reading and writing.
- Good organization and coordination skill.
- Good presentation skill.
- Good time management skill.
- Good problem solving skills and initiatives
Required Competencies 胜任能力要求(Level 1-4, see Appendix A)
- Clinical trial expertise 3
- Statistics & data analysis 2
- Disease area knowledge 2
- Product knowledge 2
- Scientific presentation & publication 2
- Customer & market insight 2
- Managing customer & internal partners 3
- Cultural diversity 3
- Project Management 3
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Clinical Research MD
Description
1. Principle Duties and Responsibilities (General summary, essential functions and authorities, etc.)
主要工作职责（基本概况，主要功能，权限等）
General Summary（基本概况）
The overall purpose of the position is specified as follows,
- Ensure clinical trial to be conducted in compliance with ICH GCP/SOPs, local regulations and protocols
- Ensure any adverse events known from clinical trials to be reported properly
- May work as a 'leader CRA' or 'project leader' on appropriate projects.
- Ensure project execution according to timeline and budget
- Develop and maintain working relationships with others requiring interaction and mutual support
- Provide guidance and coaching to less experienced CRAs and assist in their development and training.
Responsibility(工作职责)
Site Monitoring and Management:
1) Act as the main contact between sponsor and investigator site staffs.
2) Propose the potential investigational sites to project leader for a specific study. Verify the quality of the investigator and the suitability of the sites by performing study feasibility or site evaluation visit if necessary to ensure the site is qualified and suitable to conduct the study. Provide site evaluation report to project leader;
3) Ensure the smooth negotiation process on the site contract sign-off. Be responsible for site payment is properly paid according to the agreement.
4) Be involved in the preparation of the documentation for submission to EC.
5) Ensure the study is performed only after the EC approval is obtained.
6) Perform initiation, regular monitoring and close out visit to investigator site in compliance with study monitoring plan, company SOPs, local regulations and ICH GCP on budget and timeline. Prepare and submit accurate and timely site visit reports for all performed visits.
7) Manage study activities at assigned investigational sites. Discuss any issue identified and support the study sties staff as required.
8) Ensure that Investigators are aware of their responsibilities and the need to comply with company procedures, local regulations and ICH GCP.
9) Keep close follow-up on subject enrollment and protocol compliance at site to ensure the enrollment speed is aligned with planned and study implementation at site is in compliance with protocol, SOPs, relative regulations and ICH GCP.
10) Document and archive all clinical trial relevant activities;
11) Keep and maintenance the ISF and TMF to ensure it is update, complete and accurate according to SOPs, relative regulations and ICH GCP.
12) Verify the accuracy, completeness and legibility of the data collected in the studies;
13) Ensure all case report forms can be collected and queries can be resolved in a timely manner;
14) Verify the trial supply is stored, transferred, and tracked appropriately. And unused Investigational product and other study supplies is returned or destroyed at site properly after the completion of study.
15) Provide regular study updates to the project leader and update tracking tools utilized as appropriate.
16) Participate in project team meetings and provides feedback and suggestions for a successful completion of the project.
17) Prepare and participate investigator meeting as directed by the project leader.
18) Assist in the preparation for the internal or external audit/inspection. Resolve issues cited in audit reports.
19) To take on any other task as assigned by line-manager/project leader.
Project Management
1) Set up and lead the project team to ensure the study is implemented according to company policy, SOP and relative regulations.
2) Lead the project team to accomplish the proposed timeline;
3) Communicate with internal and external customers in terms of project progress and outstanding issues;
4) Lead the protocol design and approval process, provide scientific and feasibility input on the protocol and other study documents design;
5) Evaluate the potential investigational sites for a specific study in terms of the quality of the investigator and the suitability of the sites;
6) Prepare study budget proposal based on fair market value. Ensure the study is operated according to the budget
7) Actively guide and coach CRAs in the study team;
8) Coordinate with data management, statistician and medical writer to generate the statistical report and study report;
9) Evaluate the CRO, provide evaluation assessment to line manager;
10) Perform co-monitoring to team members.
11) Assess the training need of team members and assist in their development.
12) Assist in interviewing/recruiting new team members.
Technical / Professional Knowledge Input:
1) As project leader, provide feasibility assessment and input at project planning stage based on a satisfactory level of technical and professional skill or knowledge in position-related areas;
Relationship Building:
1) Build up and maintain healthy relationships with internal and external customers via smooth and efficient communications through the clinical studies
2) As project leader, support the team member to build up and maintain good relationships with study sites and internal customers..
Vendor Management:
1) As project leader, perform vendor selection and continuous quality and compliance tracking and evaluation.
2) As project leader, perform effective vendor management to ensure the services vendor provided are satisfied and qualified in compliance with J&J policy, SOP and other related requirements.
Other responsibilities defined in written procedures.（流程中规定的其它职责）
Principal Relations （inside ＆outside company）主要工作关系(公司内部和外部)
- Clinical research team in JJMC, regional, global and source companies;
- Medical affairs team in JJMC, regional, global and source companies
- Regulatory affairs team in JJMC, regional, global and source companies
- Clinical Quality Control/Assurance team in JJMC, regional, global and source companies
- Franchise marketing and leadership team;
- Finance business partners
- HCC and legal business partners
- Key opinion leaders and investigators
- SFDA technical reviewers
Qualifications
1. Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）
Personal Requirements ( include experience, knowledge，skills and education)
个人背景要求（包括经验，知识，技能和教育背景）
- Bachelor's degree & above, clinical medicine would be preferred.
- At least 2 years experience in clinical research execution, including at least 1 year project management experience.
- Strong people communication skill.
- Project management skill (e.g. good planning, implementation and follow up) is required.
- Fluent in English speaking, reading and writing.
- Good organization and coordination skill.
- Good presentation skill.
- Good time management skill.
- Good problem solving skills and initiatives
Required Competencies 胜任能力要求(Level 1-4, see Appendix A)
- Clinical trial expertise 3
- Statistics & data analysis 2
- Disease area knowledge 2
- Product knowledge 2
- Scientific presentation & publication 2
- Customer & market insight 2
- Managing customer & internal partners 3
- Cultural diversity 3
- Project Management 3
Primary Location:Asia Pacific-China-Shanghai-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Clinical Research MD