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 Senior 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 and on-site monitoring
- Excellent communication, both written and verbal, and interpersonal skills
- Fluency in English is required
- Proficiency in MS Office programs
