Clinical Site Manager II (CRA II)
The Clinical Site Manager II is a self-motivated individual able to work in a small-team environment and to independently identify tasks/issues of critical importance. In this role, you will develop a thorough knowledge of GCP, ICH and CFR principles. The successful candidate will be a highly-organized individual who can multitask and adjust direction based on changing project/corporate priorities.
As the primary point of contact for investigator sites, the CSM II ensures the clinical trial is conducted according to appropriate guidelines and protocols. You will be responsible for the efficient execution of monitoring and other clinical trial management activities while tracking the progress of assigned studies and project. Proactively identifying potential challenges, the CSM II develops appropriate actions to resolve issues and achieve target objectives
Responsibilities:
- Perform investigator site pre-study site qualification visits including collection of site regulatory documents
- Assist with site start-up activities including site contracts and budget development/negotiation and preparation of IRB submissions (including follow through to successful outcomes)
- Prepare the study reference manual, including liaising with the sponsor 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
- Participate in/lead Investigator/Initiation Meetings and ensure that the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in-line with protocol requirements
- Assist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.).
- Track movement of laboratory samples and the resulting data, including the trans-shipment of samples to specialty laboratories or movement of samples to sample management storage
- 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, all investigator and site correspondence, and schedules of payment
- Identify and complete follow-up of SAEs at study sites
- Assist with data listing, data coding and patient profile reviews, database lock, and site close-out activities
- Ensure appropriate and timely submission of documents to the Trial Master File
Skills
- Thorough knowledge of ICH/GCP guidelines
- Strong written and verbal communication ability
- Strong PC skills (MS Word, MS Excel, MS Project)
- Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
- Experience with Outsourced Clinical Trials required
- Ability to travel 50-75% required
Knowledge and Experience:
- Minimum 2-4 years field-based monitoring or other relevant experience
- Proficient in written and oral English and fluent in relevant local language
Education:
- Educated to degree level (biological science, engineering or other health-related discipline preferred) or equivalent nursing qualification