Integrity Partners Pte. Ltd. is looking for new potential candidates to fill in for CRA & SCRA position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
b) The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.
ROLE 1: 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 our client 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.
a) 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
– Ensure timely coordination of study materials (drug, non drug, equipment’s, 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.
b) Drug Safety
• 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.
c) Finance Administration
• Finalize budget and obtain signed contract from site, prior to site initiation visit.
• Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
d) Study Tools and system
• Update and maintain Study tools/systems in a timely manner
a) Provide guidance and training to entry level CRA/CRA I/CRA II in collaboration with Line Manager.
a) Academic/Major Bachelor degree or above in Medical, Pharmacology or Biology related major. College diploma can be accepted if the personal attributes and relevant project management experience are sufficiently justified.
b) Professional Skills
Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/ procedures. Good organization skills. Good working and proactive attitude. Value importance of teamwork. Ability to work independently .
c) Work Experience
At least two years and a half (for CRA with master degree or above) or three years of CRA experiences. Or qualified enough being assessed by LM with more than four years clinical research related experience or more than two years of clinical research management activities. Work experience on previous position at least 1 years
d) Language ability
Fluent in both written and spoken English Local languages fluency is preferred.
e) Computer Literacy
Excellent command of Microsoft offices.
f) Other abilities such as communication skill Information analysis skill. Knowledge and/or experience in medical practice is a plus.
How To Apply
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