RESPONSIBILITIES
In house Clinical Research Associate (In-house CRA) will act as the clinical operations person to participate in IRB and TMF document submissions related to site selection, activation, maintenance, and closeout activities, in site monitoring and compliance management, and data integrity monitoring functions within OncoC4, supporting ongoing and future OncoC4 clinical trials of novel immune therapies for cancers.
IRB Interactions
- Supports IRB submission of study related documents (protocol amendment, Informed consent forms and other documents) under the direction of the Chief Medical Officer.
- 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 e-TMF
- Maintains and completes eTMF for documents and appropriate filing of documents
- Identifies and prepares documents for country requirements in the framework of regulatory submissions as needed
- Reviews and QC checks the TMF to ensure their quality and completeness in view of audits or /and inspection or archiving and per ICH GCP requirements
Trial Management Responsibilities
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance, and study close-out.
- Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines.
- Performs data analysis and compilation to monitor protocol deviations, site performance, and data management as needed
Administrative Responsibilities
- Assist Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- Assist CRAs with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
- Perform assigned administrative tasks to support team members with clinical trial execution.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical
- Practice (GCP), International Conference on Harmonization (ICH) guidelines and FDA
- 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 institution with strong emphasis in science and/or biology
- At least 1 years of clinical research experience directly related to the duties and responsibilities specified
Please send CV and any inquires to hschiltz@oncoc4.com and wwu@oncoc4.com.