Lead Clinical Research Associate

SCOPE OF RESPONSIBILITIES

• Lead Monitoring

1.1. Supports investigator/ site feasibility and identification process

1.2. Monitors trial timelines and trial participant enrollment, implements respective corrective and preventive measures

1.3. Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors

1.4. Manages Monitors in the query resolution process, including Central Monitoring observations

1.5. Coordinates safety information flow and protocol/process deviation reporting

1.6. Performs clinical supplies management with vendors on a country and regional level

1.7. Ensures trial-specific and corporate tracking systems are updated in a timely manner

1.8. Coordinates planning of supervised monitoring visits in the trials

1.9. Conducts supervised monitoring visits for the purpose of monitoring quality checks

1.10. Manages the project team in site contracting and payments

1.11. Leads project team calls on a country level

1.12. Provides status updates and reports to Regional Lead/ Project Manager

1.13. Performs other project management tasks, when trained and delegated by the Project Manager and approved by the Line Manage

• Quality Assurance

2.1. Ensures ongoing evaluation of data integrity and compliance at a country/regional level Lead Clinical Research Associate 

2.2. Conducts site audit/inspection preparation visits, may participate in site audits/inspections, and coordinates resolution of site audit/inspection findings on a country/regional level

2.3. Conducts other types of supervised monitoring visits

2.4. Oversees project team in CAPA development and implementation

2.5. Coordinates project team in process deviations review, management and reporting

2.6. Ensures timely resolution of Site Issues and Action Items

2.7. Ensures timely identification and reporting of protocol deviations

• Training

3.1. Conducts initial training and authorization monitoring visits for Monitors

3.2. Mentors less experienced Monitors

3.3. Provides general training to Clinical Operations staff

3.4. Provides trial-specific training to project teams upon approval from the Project Manager and Regional Lead 3.5. Prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead

3.6. Delivers trainings and presentations at Investigator Meetings

• Communication

4.1. Is the main line of communication between Monitors/ Site Management Associates and the Project Manager/ Regional Lead

4.2. Supports Monitors and Site Management Associates to build and maintain good relationship with the investigator site staff

• Monitoring

5.1. Prepares and conducts all monitoring visit types

5.2. Ensures that participant recruitment targets and trial timelines are properly defined, communicated, recorded, and met at site level, and provides timely updates to Regional Lead and Project Manager

5.3. Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations

5.4. Supervises source data verification and follows up on data queries at a site level in the country/region; reviews and manages trial risks on a site level

5.5. Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical trial supplies on a country/region level

5.6. Ensures data integrity and compliance at site level

5.7. Participates in trial site audits and client onsite visits, as required

• Site Management

6.1. Supervises Site Management Associates in the flow of trial records and laboratory supplies between the site and the Central/ Regional Laboratory/ Central Reviewer/Warehouse

6.2. Supports preparation of Investigator newsletters

• Trial Records Management

7.1. Supervises IP-RED packages collection and review

-Relevant educational background, such as MD, MPharm, RN or University degree in Life Sciences or an equivalent combination of education experience.

-Minimum of 5 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor.

-Must have prior experience monitoring or managing sites and CRAs in China with knowledge of China regulatory guidelines and practices.

-Experience with all types of monitoring visits in Phases I-III.

-Strong experience in Oncology preferred.

-Full working proficiency in English.

-Proficiency in MS Office applications.

-Ability to plan, multitask and work in a dynamic team environment. Excellent Communication, collaboration, and problem-solving skills

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