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;

- Valuable 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.

Welcome passion and creative ideas' friends! Look forward to receiving your profiles.

📌 CRA/SCRA-Canada
🏢 Tigermed
📍 Canada