Clinical trials associate vs research project coordinator

Differences between clinical trials associate and research project coordinator duties and responsibilities

Clinical trials associate example responsibilities.

• Manage trial master files and study document to meet GCP/ICH and internal guidelines for records retention.
• Audit TMF to ensure all require regulatory documentation are collected and lead.
• Work closely with investigators to recruit eligible patients to clinical protocols, manage data collection and preparation.
• Preform ICF customization in accordance with ICH guidelines, GCP s and local regulatory requirements.
• Support the setup, data entry and QC of the system to ensure accuracy and quality of data.
• Monitor clinical data and resolve inconsistencies according to FDA regulations and ICF guidelines.
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Research project coordinator example responsibilities.

• Manage study documentation throughout study life cycle including IRB annual renewals, modifications, patient study charts and regulatory binder.
• Recommend administrative revisions to IRB submit studies including inform consent documents.
• Demonstrate small molecule are protective against DNA damage in mouse model of melanoma.
• Conduct analysis using SPSS which result in developing a new software for students to selecting college.
• Conduct primary research through interviews with Boston area travelers and analyze raw data into reports via SPSS.
• Maintain FDA correspondence and government documentation.
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