Mexico, Brazil, Malaysia, Poland, Hungary, Bulgaria, Croatia, US, Australia
Mexico, Brazil, Malaysia, Poland, Hungary, Bulgaria, Croatia, US, Australia.
1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.
1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.
Part I: Project Team Leadership and Management
Planning of project activities and study timelines based on project goal and sponsor's expectation.
Organize and Lead meeting/teleconferences for study activities implementation (e.g. investigator meeting, project review meeting etc), monitoring the progress of each CRA responsible sites, and assessing overall status of the project.
Develop the project management plan, monitoring plan etc as required for the study.
Develop study specific tools/forms, study templates as required for the study.
Develop and manage project budget.
Order and ensure all clinical supplies (including drug and non-drug) are adequate for all sites throughout the study period.
Ensure all team members have timely access to appropriate systems and tools, if applicable (e.g. IVRS, eCRF etc).
Organize and conduct site feasibility visits according to guidelines and make recommendation for final approval.
Coordinate the application of specimen export permit, if applicable.
Maintain and manage all project trial master files throughout the study period and coordinate the long term archiving and handover to sponsor at the end of the study.
Conduct the co-visit at site with CRA according to Tigermed SOP.
Track study progress and ensure project is conducted according to the plan.
Communicate to monitors new study information, study timelines and goals, study requirements. Responsible for raising overall project specific issues to management (e.g. Project Director, Senior Management).
Submit the weekly project report to management (e.g. Project Director, Senior Management).
Communicate to sponsor study status and key issues.
Generate monthly project status report to sponsor.
Part II: Study Implementation
2.5 Site management:
Study site selection, initiation (SIV) and clinical monitoring.
Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.
Track study recruitment to ensure recruitment target is achieved in all studies.
Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.
Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.
Assemble site specific EC submission dossier, and ensure submission to EC.
Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.
Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.
Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.
Prepare/complete study records’ archiving according to protocol and sponsor requirements.
Ensure safety information is disseminated to all sites according SOP and applicable regulations.
Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.
Finalize budget and obtain signed contract from site, prior to site initiation visit.
Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
Study Tools and system:
Update and maintain Study tools/systems in a timely manner
Part III: Mentoring
provide guidance and training to entry level CRA/CRA I/CRA II in collaboration with Line Manager.
3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;
3.2 At least 1 year of CRA experience;
3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;
3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.