1. Job Purpose:
- This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations;
- The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.
2. Responsibilities:
- Planning of project activities and study timelines based on project goal andsponsor's expectation;
- Organize and Lead meeting/teleconferences for study activities implementation(e.g. investigator meeting, project review meeting etc), monitoring the progressof each CRA responsible sites, and assessing overall status of the project;
- Develop the project management plan, monitoring plan etc as required for thestudy;
- Develop study specific tools/forms, study templates as required for the study;
- Develop and manage project budget;
- Order and ensure all clinical supplies (including drug and nondrug) areadequate for all sites throughout the study period;
- Ensure all team members have timely access to appropriate systems and tools, ifapplicable (e.g. IVRS, eCRF etc);
- Organize and conduct site feasibility visits according to guidelines and makerecommendation for final approval;
- Track study progress and ensure project is conducted according to the plan;
- Communicate to monitors new study information, study timelines and goals,study requirements. Responsible for raising overall project specific issues tomanagement (e.g. Project Director, Senior Management);
- Submit the weekly project report to management (e.g. Project Director, SeniorManagement);
- Study site selection, initiation (SIV) and clinical monitoring;
- Perform prestudy visit to ensure eligible sites are selected according to sponsorsite selection criteria, including but not limited to adequate resources andexperience;
- Prepare and conduct SIV to ensure adequate study training for relevant site staffto proceed with study start and conduct in compliance with protocol andrelevant regulations;
- Provide ongoing training to site staff with regards to ICHGCP, GCP, studyprotocol, and requirements;
- Ensure timely collection of essential documents in compliance with protocol andregulations at study startup, during and at study closedown. Maintain andupdate these documents in investigator files, trial master files;
- Finalize budget and obtain signed contract from site, prior to site initiation visit;
- Provide guidance and training to entrylevel CRA/CRA I/CRA II in collaborationwith Line Manager.
- Submit the weekly project report to management (e.g. Project Director, Senior Management);
- Study site selection, initiation (SIV) and clinical monitoring;
- Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience;
- Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations;
- Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol, and requirements;
- Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files;
- Finalize budget and obtain signed contract from site, prior to site initiation visit;
- Provide guidance and training to entry-level CRA/CRA I/CRA II in collaboration with Line Manager.
3. Qualifications:
- Work location is based in Canada, business travel to Western US is required;
- Bachelor degree or above in Medical, Pharmacology or Biology related major;
- Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;
- At least 1-3 years of CRA experiences;
- Good command of written and verbal English;
- Good skills on Microsoft Word, Excel, PPT and Outlook, etc.;
- Other abilities such as Communication skills/Information-gathering skills. Knowledge and/or experience in medical practice is a plus.
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