CRA/SCRA-Western based

About the role

This position is responsible for project management and study site management from site selection to initiation through monitoring and close-out of assigned clinical 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 ensures that all data generated by the assigned sites is of high quality, on time and within budget.

Responsibilities

• Plan project activities and study timelines based on project goals and sponsor expectations
• Organize and lead meetings/teleconferences for study activities implementation (e.g., investigator meeting, project review meeting), monitor the progress of each CRA responsible site, and assess overall project status
• Develop the project management plan, monitoring plan, and other required study documents
• Develop study-specific tools/forms and templates as required
• 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 (e.g., IVRS, eCRF)
• Organize and conduct site feasibility visits according to guidelines and make recommendations for final approval
• Track study progress and ensure the project is conducted according to the plan
• Communicate to monitors new study information, timelines, goals, and requirements; raise project-specific issues to management (e.g., Project Director, Senior Management)
• Submit weekly project reports to management
• Perform site selection, initiation (SIV), and clinical monitoring
• Conduct pre-study visits to ensure eligible sites are selected according to sponsor criteria, including adequate resources and experience
• Prepare and conduct SIVs to ensure adequate study training for site staff in compliance with protocol and regulations
• Provide ongoing training to site staff regarding 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 and trial master files
• Finalize budget and obtain signed contracts from sites prior to site initiation visits
• Provide guidance and training to entry-level CRA/CRA I/CRA II in collaboration with the Line Manager

Qualifications

• Work location is based in the Western U.S.
• Bachelor’s degree or above in a medical, pharmacology, or biology-related major
• Good understanding and knowledge of Good Clinical Practice and clinical trial operations processes/procedures
• At least 1–3 years of CRA experience
• Strong written and verbal English skills
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
• Strong communication and information-gathering skills
• Knowledge and/or experience in medical practice is a plus