Clinical Research Associate

ost Job to: Monroe Branch: PhilippinesTemplate to use:Healthcare DepartmentClinical OperationsIndustryHealthcare SalaryPhp 60,000-70,000Years of Experience1-2 years experience in Clinical Monitoring LocationMetro Manila, PhilippinesEducation LevelBachelor's degree in Life Sciences, Chemistry or health related Company & Job Description Executive search firm 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. Key job responsibilities include: 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 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 Excellent communication, both written and verbal, and interpersonal skills Fluency in English is required Proficiency in MS Office programs SignatureAll applications will be treated in the strictest of confidence. If you are a suitable match for this position please send your application to

• Manila
• Permanent
• Negotiable