Senior Clinical Research Associate

Tigermed; United States; On-site; USD 60,000 - 90,000; Full time

Job summary

A leading clinical research organization is seeking a Clinical Study Manager responsible for overseeing project management and site management for clinical studies. The role requires a Bachelor's degree in a relevant field and at least 1-3 years of experience in Oncology as a Clinical Research Associate. Key responsibilities include planning activities, managing budgets, leading meetings, and ensuring compliance with study protocols. Strong communication skills and an understanding of Good Clinical Practice are essential for success in this position.

Qualifications

• Bachelor's degree or above required in relevant fields.
• 1-3 years of CRA experience in Oncology is preferred.
• Strong understanding of GCP and clinical trial processes.

Responsibilities

• Manage clinical study activities from selection to close-out.
• Plan project activities and timelines based on goals.
• Develop study management plans and budgets.
• Organize and lead meetings and teleconferences.

Skills

Project management

Oncology CRA experience

Communication skills

Information-gathering skills

Good command of written and verbal English

Education

Bachelor degree in Medical, Pharmacology or Biology

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

Overview

• 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.

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.

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 Oncology CRA experience;
• 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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