職位描述
The Clinical Research Associate (CRA) is a key member of the Clinical Project Team and is responsible for managing investigator sites for selected studies. Incumbents monitor specified sites to ensure data integrity and compliance with Chiltern International or Client’s SOPs, ICH GCP and or ISO 14155, regulatory requirements and the project protocol. Incumbents are responsible for ensuring that projects are completed on time and within budget.
Clinical Research Associate - 1(Entry)
1. Prepare and conduct site visits including (but not limited to): qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs, local requirements, the protocol and project plans as well as providing timely and comprehensive visit and status (i.e. patient recruitment) reports under supervision.
2. Communicate effectively with Chiltern Project Team members (i.e. Clinical Team Leader, Project Managers, Safety and Data Management) to ensure study completion per company and client requirements and timelines.
3. Proactively communicate with study sites and follow-up on all open issues in order to meet the project timelines under guidance of the project team. Ensure that all study-related documentation is tracked, printed, and filed as required by Chiltern SOPs, regulatory requirements, and other protocols.
4. To ensure that investigator site files are assembled appropriately and that all required documentation is in place, tracked and reconciled on a regular basis against the TMF files.
5. Perform other duties as required by the Department or Project Team.
Clinical Research Associate - 2 (Experienced)
1. Prepare and conduct site visits including (but not limited to): qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs, local requirements, the protocol and project plans as well as providing timely and comprehensive visit and status (i.e. patient recruitment) reports.
2. Communicate effectively with Chiltern Project Team members (i.e. Clinical Team Leader, Project Managers, Safety and Data Management) to ensure study completion per company and client requirements and timelines.
3. Proactively communicate with study sites and follow-up on all open issues in order to meet the project timelines. Ensure that all study-related documentation is tracked, printed, and filed as required by Chiltern SOPs, regulatory requirements, and other protocols.
4. To ensure that investigator site files are assembled appropriately and that all required documentation is in place, tracked and reconciled on a regular basis against the TMF files.
5. May support in mentoring less experienced CRAs on project or department tasks and requirements.
6. Perform other duties as required by the Department or Project Team.
Clinical Research Associate – 3 (Senior)
1. Prepare and conduct site visits including (but not limited to): qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs, local requirements, the protocol and project plans as well as providing timely and comprehensive visit and status (i.e. patient recruitment) reports.
2. Communicate effectively with Chiltern Project Team members (i.e. Clinical Team Leader, Project Managers, Safety and Data Management) to ensure study completion per company and client requirements and timelines. Being a pro-active member in team calls and act as a role model. May support in the creation of CRA working tools based on the experience on the project.
3. Proactively communicate with study sites and follow-up on all open issues in order to meet the project timelines. Ensure that all study-related documentation is tracked, printed, and filed as required by Chiltern SOPs, regulatory requirements, and other protocols.
4. To ensure that investigator site files are assembled appropriately and that all required documentation is in place, tracked and reconciled on a regular basis against the TMF files.
5. May support in mentoring less experienced CRAs on project or department tasks and requirements.
6. May support in conducting quality control accompanied visits with CRAs level 1 or 2.
7. Perform other duties as required by the Department or Project Team.
