RESPONSIBILITIES

IRB Interactions

• Performs IRB submission of study related documents (protocol amendment, Informed consent forms and other documents) under the direction of the Chief Medical
• Ensures that all IRB related documents (IRB submission documents, IRB correspondence and approvals) are properly filed in the e-TMF
• Serves as a point of contact for IRB related issues

e-TMF Responsibilities

• Be responsible to set up and administrate the eTMF or set up the paper TMF files
• To maintain and complete the paper and electronic TMF for documents and appropriate filing of documents,
• Identify and prepare documents for country requirements in the framework of regulatory submissions as needed,
• Responsible for ensuring CRO e-TMF or paper TMF organization and completeness as per ICH GCP requirements
• Review and QC check of the TMF to ensure their quality and completeness in view of audits or /and inspection or

Administrative Responsibilities

• Assist Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project
• Assist CRAs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking
• Act as a central contact for the clinical team for designated project communications, correspondence and associated
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required
• Perform assigned administrative tasks to support team members with clinical trial

 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of applicable clinical research regulatory requirements, e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and FDA guidelines.
• Knowledge of IRB guidelines and processes
• Knowledge of applicable protocol requirements as provided in company training
• Knowledge of e-TMF set up and maintenance processes
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
• Good written and verbal communication skills including good command of English language
• Effective time management and organizational skills
• Ability to establish and maintain effective working relationships with coworkers

 

POSITION REQUIREMENTS

• Bachelor's degree in Sciences from an accredited
• At least 2 years of clinical research experience directly related to the duties and responsibilities

Please send CV and any inquires to hschiltz@oncoc4.com and hychou@oncoc4.com.