Clinical Research Malaysia is looking for new potential candidates to fill in for Study Coordinator position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
Study Coordinator tasks;
- Report to Associate Regional Manager.
- Update Investigator database from hospital & satellite sites, Investigator GCP list and feasibility log.
- Manage & coordinate the feasibility study received from Feasibility Team, including meeting new & potential Investigators who are interested. To support and follow up the completion of feasibility questionnaires within timelines.
- Submit monthly ISR report to Associate Regional Manager on the ISR status including upcoming new trials, ongoing trials, closure status of the trials.
- Inform and update Associate Regional Manager on any new potential studies at project site.
- Assist in the preparing and conduct of site visit from sponsors/CROs including but not limited to site selection visit, site initiation visit, site monitoring visit, site closure visit and other.
- Act as liaison between Investigators and other clinical research stakeholders (including CROs/Sponsor, Regulatory Agency and others) to support site on audit and inspection readiness and subsequent implementation of recommended corrective actions as appropriate.
- To guide and support Investigators on the payment process of study budget.
- To conduct the task as delegated by the Investigator in accordance to the protocol, SOP and applicable guidelines.
- Assist in the recruitment of study subjects by performing pre-screening activities as delegated and in accordance to the SOP.
- Schedule and manage subject visit. Assist Investigator during subject’s visit in accordance to protocol.
- To ensure timely and accurate completion of Case Report Form (CRF)/e-CRF and queries resolution.
- Handling and preparing specimen for vendor’s collection.
- Handling of Investigational Product (IP) and manage the storage and record of IPs including resupply, dispensing, maintaining the accountability of IPs.
- Handling of clinical supplies and manage the storage and record of this including resupply, dispensing, maintaining the accountability of IPs.
- To assist Investigators in the subject safety management including timely reporting (Initial/FUL) of SAEs to the appropriate authorities.
- Adhere to all Standard Operating Procedures and guidelines provided under the ISO 9001:2015 requirements.
- Ensure relevant activities related to Clinical Operations are in line with Good Clinical Practice (GCP) and ISO standards.
BASIC JOB REQUIREMENTS
- Degree in Biomedical / Biotechnology / Nursing
- Knowledge in clinical trials is essential to be able to adapt to the job requirement
- Have prior experience in research field/clinical
- Meticulous, detailed, well-organized and able to work independently to meet datelines
- Excellent communication and interpersonal skills
- Resourceful and able to multitask
- Certified GCP, completed Hands On Training and Training Log Book
We are a government-owned company dedicated to promote and accelerate Clinical Contract Research in the country. Clinical Research Malaysia (CRM) is a Ministry of Health initiative under the National Key Economic Area for healthcare. CRM provide global health solutions for the people through clinical research. Our deep understanding of the local clinical research landscape with the international standards of operations coupled with fundamental backing of the MoH provide us an incomparable advantage to deliver research and create high skilled job opportunities.
Our vision is ‘To Establish Malaysia As a Preferred Destination for Clinical Contract Research’.
How To Apply
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