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Monroe Branch: | Philippines | Template to use: | Healthcare | ||
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Department | Clinical Research Associate (CRAI/ CRAII) | Industry | Digital Health | ||
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Salary | Php 50,000-Php 60,000 | Years of Experience | At least 2 to 3 years of experience as CRA | ||
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Location | Remote work | Education Level | Bachelor's degree in life science, chemistry, or health is preferred. | ||
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Company & Job Description | Clinical Research Associate (CRAI/ CRAII) Executive recruitment company Monroe Consulting Group Philippines is recruiting on behalf of a multinational company that provides consulting and clinical trial support services for companies without entities in SEA. Our respected client is seeking a Clinical Research Associate that will handle the Philippine market. The candidate will work remote. Job responsibilities: Clinical Development Operations · Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects' rights, safety and well-being are being protected. · Primary point of contact of trial sites with regards to the conduct of the study/ project · Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work · Ensure that the sites are adequately trained on the protocol and other study specific requirements · Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan · Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF). · Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary. · Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution. · Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF) · Track site budget and payments · May be involved in preparation of status reports for clients · Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary · Act as mentor/coach to more junior staff as necessary · Travel as necessary according to project needs · Perform other duties as assigned by line manager
Regulatory: · Ensure study start up processes are done according to applicable SOPs and regulatory requirements · Prepare and submit regulatory and clinical documents to Regulatory Agencies and Independent Ethics committee (IEC)/Institutional Review Board (IRB) · Ensure that product labels are compliant with applicable regulatory requirements · Collect and submit necessary documents for study drug importation, return and/ or destruction · Ensure that all documents necessary for site activation are collected | ||||
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Job Requirements | · Bachelor's degree in life science, chemistry, or health is preferred. · ICH-GCP training is required · Relevant experience on conduct of clinical trials and on-site monitoring · Excellent communication, both written and verbal, and interpersonal skills · Fluency in English is required · Proficiency in MS Office program | ||||
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Signature | All applications will be treated in the strictest of confidence. If you are a suitable match for this position please send your application | ||||
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