Company & Job Description |
Clinical Research Coordinator
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 Coordinator that will handle the Philippine market. The candidate will work remote.
Job responsibilities:
Clinical Development Operations
* Coordinates with Site, Sponsor, University, and CRO to help ensure that clinical research is
performed in accordance with local, federal, and sponsor regulations, policies, and procedures.
* Assists PI in development of materials and tools necessary to appropriately train individuals
involved in the conduct of the study around issues related to (but not limited to) protocol
requirements, schedule of visits, execution of research plan.
* Assists PI to assure that all key personnel or persons 'engaged' in the research project have met
training requirements in accordance with federal regulations and Sponsor policies and
procedures.
* Prepares IRB/HRPO and any other regulatory submission documents as required by the
protocol.
* Prepares other study materials such as the informed consent document, case report forms
(CRFs), enrollment logs, and drug/device accountability logs.
* Establishes and organizes study files, including but not limited to, regulatory binders, study
specific source documentation and other materials.
* Collects documents needed to initiate the study (e.g., FDA Forms 1572, CVs, etc.).
* Assists screening subjects for eligibility using protocol specific inclusion and exclusion criteria,
documenting each potential participant's eligibility or exclusion.
* Conducts or participates in the informed consent process including interactions with the
IRB/HRPO and discussions with research participants, including answering any questions related
to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures
that amended consent forms are appropriately implemented and signed.
* Coordinates participant tests and procedures.
* Collects data as required by the protocol. Assures timely completion of Case Report Forms.
* Coordinates and facilitates monitoring visit.
* Coordinates auditing visit and collaborates with PI and institution to respond to any audit
findings and implement approved recommendations.
* Registers each participant in the billing matrix to ensure billing of study procedures to the
appropriate funding source.
* Maintains study timelines.
* Maintains adequate inventory of study supplies.
* Maintains effective and ongoing communication with Site, Sponsor, University, and CRO during
the course of the study.
* Participate in internal and external meetings
* Perform other duties as assigned by line manager
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