Clinical Research Associate - United, Pennsylvania, US

1. Job Purpose:

The information below covers the role requirements, expected candidate experience, and accompanying qualifications.

• 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 and sponsor's expectation;
• Organize and Lead meeting/teleconferences for study activities implementation (e.g. investigator meeting, project review meeting etc), monitoring the progress of each CRA responsible sites, and assessing overall status of the project;
• Develop the project management plan, monitoring plan etc as required for the study;
• 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 non-drug) are adequate for all sites throughout the study period;
• Ensure all team members have timely access to appropriate systems and tools, if applicable (e.g. IVRS, eCRF etc);
• Organize and conduct site feasibility visits according to guidelines and make recommendation 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 to management (e.g. Project Director, Senior Management);
• 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:

• 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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