Note: The job is a remote job and is open to candidates in USA. SystImmune is seeking a high quality, ambitious and experienced Clinical Research Associate II (CRA II) to support SystImmune’s clinical trials. The CRA II is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
Responsibilities
- Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits
- Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites
- Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug
- Assist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)
- Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters or other potential creative solutions)
- Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication
- Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
- Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, and all investigator and site correspondence
- Identify and complete follow- up of SAEs at study sites
- Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities
- Ensure appropriate and timely submission of documents to the Trial Master File
- Perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP
Skills
- Bachelor's degree in health science or related field
- 2+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits
- Excellent verbal and written communication skills required
- Excellent organizational, multi-tasking and time management skills required
- Demonstrated experience developing/maintaining site relationships and securing compliance
- Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines
- Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)
- Ability to travel as required (50-75%)
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