About the Role: We are seeking a highly skilled Senior Clinical Research Associate to join our Clinical Operations team. As a Senior CRA, you will be responsible for setting up, monitoring, and closing out clinical trial sites, as well as negotiating budgets and liaising with regulatory authorities. You will work closely with Clinical Trial Managers, sponsors, project managers, and other team members to ensure study deliverables are met within project timelines.
Main Responsibilities:
* Contribute to site identification and feasibility assessments.
* Manage all aspects of study site management, including training site staff, ensuring supply of study materials, and monitoring recruitment updates.
* Collect and assess essential documents, perform reconciliation of Investigator Site File, and conduct pre-study visits, site initiation visits, site monitoring visits, and site closeout visits according to SOPs/WPDs.
* Assess IP accountability, dispensation, and compliance at investigative sites and prepare accurate and timely visit reports in accordance with the monitoring plan and/or SOPs.
* Collaborate with project functional leads as needed and attend internal and external project calls to provide required site updates.
* Demonstrate working knowledge of applications and systems, including CTMS, eTMF, IVRS/IWRS, and EDC.
* Facilitate site audits and audit finding resolutions, supervise work of less experienced CRAs, and serve as an observational visit leader.
* Provide feedback to management and cross-functional study teams on any current or potential risks or problems affecting the conduct of the clinical trial and escalate any issues related to Quality or Data integrity in a timely manner.
Key Requirements:
* Bachelor's degree in Nursing, Life Sciences, or Medical Sciences, or equivalent work experience required.
* Previous experience as a Clinical Research Associate with strong demonstration of clinical research fundamentals.
* Good experience in CTMS, eTMF, IXRS, and EDC systems.
* Previous CRO experience and proficiency in written and spoken English; fluent in host country language.
* Good knowledge of regional clinical research regulations and ICH-GCP.
* Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge.
* Ability to establish/maintain good relationships with sites/colleagues/clients and make decisions independently.
* Highly developed mentoring and motivational skills and advanced degree (Masters, MD, PhD).
* Competent in clinical trial planning and metrics management.