SMA I

An In-house Clinical Research Associate will work closely with the Clinical Research Associates (CRAs) by providing centralized support to regional team members, assisting with the preparation, organization and follow-up of investigator/site communications and clinical monitoring tracking at a site, regional and global level. In addition, the In-house CRA will liaise with the study team to ensure study information is proper communication to the site and CRAs.

Performs remote site management and monitoring activities on assigned project(s) in accordance with FDA/EMA and/or local regulations and guidelines, ICH GCPs. Reviews study data from various sources remotely. Contacts study sites to collect study documentation, resolves issues and requests outstanding information. Provide general support to the CRAs to manage investigational sites and ensure protocol and regulatory compliance Remotely reviews EDC Remotely reviews drug accountability log (when possible) Ensures study systems are updated per agreed study conventions (e.g. CTMS) To assist local SSU specialist with contracts negotiations and RGL’s site documentation Perform QC of the eTMF (country/site level) for a certain study Assist investigational sites with study start-up activities to ensure study specific supplies are received Assist with the development of training content (monitoring visit training materials, monitoring visit reports, etc.) as needed To contact Clinical sites for specific requests between visits: Enrollment updates, challenges with recruitment, supplies Missing TMF documentation Data entry timelines, data query follow-up Follow-up on action items from previous site visits Track patient enrollment and assist with recruitment efforts by maintaining regular site contact To assist CRAs with preparation and follow-up for all types of site visits (Communicating data entry, queries, tracking reports IRT/DM/Imaging/eCOA/Labs, TMF support and maintenance, site performance, point of escalation, etc.) Serve as primary CRA back-up for the site May assist with tracking project specific training for site personnel Conduct Pre-Study visits and/or Close-out Visits as needed; Independently as approved Co-monitor on assigned studies as needed Assist with site quality management activities, including site audits and site inspections Assist the CRA with Action Item and Protocol Deviation review and follow-up Maintain FAQ list for assigned studies, as needed Document site and sponsor contact and study interactions in a timely and professional manner Assist with resolution of investigational site data queries, especially during interim activities and DB Lock May provide study-specific direction, training, and mentoring to the monitoring team members