CRA/SCRA-Western based

Tigermed; United States; On-site; USD 70,000 - 110,000; Full time

Job summary

Tigermed seeks a Project Manager/CRA to oversee clinical studies from site selection through initiation, monitoring and close-out, in line with ICH-GCP and sponsor SOPs.

The role emphasizes site management, budget oversight, timelines, data quality, and coordination with investigators and monitoring staff at a Western US-based site.

Qualifications

• 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.

Responsibilities

• Plan project activities and timelines based on goals and sponsor expectations.
• Organize and lead meetings for study implementation and monitor progress of sites.
• Develop project management plans, monitoring plans, and study tools/forms as required.
• Manage study budgets and ensure adequate clinical supplies across sites.

Skills

Communication skills

English proficiency

Education

Bachelor's degree in Medical, Pharmacology or Biology

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

• 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 Western US.
• 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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