Company: Confidential
Job Title: Sr. Clinical Research Associate
Job Number: 83754
Location: , US
Job Description
The Sr. Clinical Research Associate supports the initiation, execution, and compliance of clinical studies, ensuring accuracy and quality in a cost-effective manner. Collaborating with clinical operations and vendors, the Sr. CRA helps establish key practices and processes for future growth.
Responsibilities
* Develop and maintain investigator relationships, ensuring protocol adherence and regular progress reviews. * Ensure compliance with ICH-GCP and regulations. * Facilitate scientific discussions on product and protocol requirements. * Monitor and resolve vendor issues, guiding them on protocol and data questions. * Train and assist site staff in timely and accurate data collection. * Conduct site evaluations, initiations, monitoring, and close-out visits. * Provide protocol and study-related training to sites. * Monitor sites for compliance with protocols, SOPs, and regulations. * Manage device/medication inventory and accountability. * Ensure the accuracy and quality of data through regular reviews and source data verification. * Manage multiple tasks and unpredictable scenarios while meeting project timelines. * Provide regular project updates to Clinical Operations. * Ensure the protection of trial subjects and accuracy of data. * Perform all activities in compliance with regulations and company policies.
Required Skills
* Bachelor’s degree in a science-based field (Nursing preferred). * 5+ years of clinical trial monitoring experience; biotech, pharmaceutical, or medical device experience preferred. * Knowledge of GCP and ICH guidelines. * Proficiency in Microsoft Office and Adobe Acrobat. * Experience with clinical trial systems (e.g., TMF/eTMF, CTMS, EDC) preferred. * Strong organizational, problem-solving, and time management skills. * Track record of success in dynamic environments with effective communication and collaboration. * Up to 50-75% travel required.#LI-DNI
Application Deadline: 2024-09-30
To apply for this job please visit jobrxiv.org.