Sr. CRA- Medical Device-Cardiovascular

To support 1 protocol in the cardiovascular / electrophysiology medical device space.

What will you be doing?

• Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, etc.
• Contribute to quality Site Selection through participation in site feasibility and / or pre‐trial site assessment visits, providing recommendation from local area about site / investigator selection in collaboration with the trial team.
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial (investigator meetings, site visits, quality communication, etc.).
• Drive study compliance by executing activities within site initiation and start‐up, site monitoring, site management and site / study close‐out according to internal SOPs / WIs / IFUs and policies.
• Ensures site staff is trained, and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site is equipped to carry out the trial with adequate site study supplies (such as Non‐IP, lab kits, etc.) and clinical drug / device / biologic supplies. This will include oversight of proper handling, storage and return and / or destruction with accurate inventory maintained / documented.
• Ensures quality data (accurate, valid and complete) is provided by the site and queries resolved within expected timelines.
• Ensures trial subject safety in that all AEs / SAEs / UADEs / PQCs are reported within the required reporting timelines and documented as appropriate, with supporting data collected and verifiable with information in the source documents.
• Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF / IF) according to expectations (metrics) and archiving retention requirements, including storage in a secure area at all times.
• Focuses on Investigator engagement through timely follow up with sites. Completes follow‐up letter to communicate relevant information and required corrective action to the investigator and his / her team with required timeframes. Promptly communicates relevant status information and issues to appropriate stakeholders. Follows the corresponding Project Operations Manual (POM) / Monitoring Guidelines for each assigned trial.
• Collaborates with LTM / CTL for documenting and communicating site / study progress and issues to trial central team.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge sufficient for role and responsibilities.
• Works closely with LTM / CTL to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
• If applicable, will negotiate investigator budgets at site level, track costs and ensure payments are made at site level, maintaining site relationships.
• May participate in the HA and IEC / IRB submission and notification processes as required / appropriate.
• May contribute as a mentor to a less experienced site manager or to process improvement and training, as appropriate for business needs.
• Full utilization by timely and accurate time reporting.
• If applicable, region specific deliverables will be specified.
• Advanced :
• Autonomy in execution of site management services
• Depth of knowledge with site management services
• Process leadership