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Department Clinical Operations Asia
Employment Type Full Time
Minimum Experience Experienced
Regional Lead CRA - ASIA
Novotech is internationally recognised as the leading independent and full-service contract research organisation (CRO) in the Asia Pacific region. We provide a wide range clinical development services across all research phases and therapeutic areas; and have been instrumental in the success of hundreds of Phase I - IV clinical trials throughout the Asia Pacific.
Powered by the highest quality people, Novotech strives to set the benchmark for both business and clinical trial performance.
Our people are one of our key strengths. We value our people and recognise the work they do. We are lucky to have the best people and talent from across the Asia Pacific region work together to deliver to clinical trial success for our clients.
Our people and those we look to recruit have an attitude of making things happen. They are problem solvers, driven with a focus on delivering quality, accountability and a high level of performance.
About the position:
The Regional Lead Clinical Research Associate provides direction and guidance to the project team, coordinating site management and monitoring activities, and communicating status of these activities to the Project Manager (PM).
Regional LCRA responsibilities may include, but are not limited to;
- Support and coordinate feasibility, site identification, and site selection activities for multi-regional studies
- Lead and assist with preparation of initial ethics and regulatory submission package and oversight on approval processes and timelines
- Support PM with application and tracking Investigational Product (IP) and ancillaries import/export permits and licenses
- Work with PM to coordinate initial IP shipment across regions
- Review Site Activation Forms and related essential documents; will assist PM with Project and Country Activation Forms as requested across regions.
- Assist with aspects of CTMS set-up
- Prepare for and attend Investigator meetings; may present materials as requested.
- Prepare master site budget based on sponsor requirements and assist CRAs in negotiating individual budgets and contracts with sites.
- Coordinating legal review of any changes to the Clinical Trial Research Agreement (CTRA) document creation and maintenance.
- Prepare or review the Study Plans, including but not limited to the Clinical Monitoring Plan (CMP) and update plans during the study
- Develop and distributes Source Data Verification/Monitoring tools and trackers
- Develop and distribute an annotated report template and template visits confirmation/follow-up letters in accordance with any Sponsor requirements.
- Maintain ICF version tracking and assist with ICF translation process if required
- Maintain document translation tracking and follow-up with specific translation tasks if required.
- Lead internal CRA meetings/teleconferences and may be required to prepare for the meeting, presenting a section of the agenda and follow-up with specific tasks. May assist with preparing the agenda, meeting minutes and distributing additional communication
- May attend Sponsor meetings and contribute as required. May assist with preparing the agenda, meeting minutes and distributing additional communication
- May correspond directly with the sponsor to provide information/updates
- Prepare site newsletters/emails to keep site staff informed of key communication
- Support the PM with vendor management, e.g. central laboratory, IVRS/IWRS providers
- Support the PM in ensuring CRAs are adequately trained on project specific requirements including study protocol, specific procedures, project plans, and related forms and the Case Report Form
- Assist with and track the ethics and regulatory submission and approval processes during the course of the study in CTMS
- Work with PM to coordinate IP re-supply as required
- Support PM in developing and implementing subject recruitment strategies at the study and site level
- Assist with CTMS maintenance during the course of the project
- Review visit reports and site follow-up letters for compliance with ICH-GCP and the CMP; provide final approved documents to Sponsor as required and track report metrics in CTMS
- Track the resolution of follow-up issues from site visits
- Maintain protocol deviation tracking in CTMS
- Ensure appropriate issue escalation and tracking of these to resolution, proactive identification of areas of risk and develop risk management strategies
- Oversee safety reporting processes to ensure in line with local and regional regulatory requirements
- Provide guidance to CRA team through mentoring and consistent communication.
- Oversee data collection and query resolution throughout the project
- Prepare the Project Filing plan and ensure CRA team is trained on TMF filing requirements including submitting required documents for the TMF/eTMF/SSF/Novotech Network file on an ongoing basis throughout the project and ensuring TMF Quality Reviews are completed as per the Filing plan to validate TMF and current and complete.
- Oversee and coordinate timely reviews and documented reconciliations of the TMF by the project team at the indicated timepoints per the project filing plan.
- Assist PM with response to audit findings and assist CRAs with completion of any CAPA review and documentation
- May perform Accompanied Assessment Visit or co-monitoring visits as required
- Support PM with managing CRA resources to ensure monitoring activities are within budget and notifying the PM of any changes required or changes in scope
- Support PM with finance activities, e.g. timesheet review, pass-through review, forecasting, revenue recognition and change orders
- Assist the PM to oversee and coordinate the timely completion of Investigator payments by the project and finance teams in accordance the schedule detailed in the Clinical Trial Agreement.
- Track Investigator payments or ensure being tracked by Centralised Investigator Payment team
- Serve as back-up PM and back-up CRA as necessary during team absences.
To deliver clinical trial and research excellence for our clients, our people are 'best in class'.
At Novotech, we seek and nurture people with exceptional talent. We are committed to providing our people with regular internal and external training, a competitive bonus structure and a supportive work environment. We are also focused on providing our people with a wide variety of career growth and development opportunities.
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