[Remote] Sr. Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. reputed company is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. They are seeking a Senior Clinical Research Associate (CRA) to manage and reputed company clinical study sites, ensuring data quality and patient safety in accordance with ICH-GCP guidelines and local regulations.

Responsibilities

• reputed company Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and reputed company Out Visits
• Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) 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 reputed company contractual and regulatory requirements for site initiation and first release of study drug
• Assist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)
• 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 reputed company 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, and reputed company investigator and site correspondence
• Identify and complete follow-up of SAEs at study sites
• Assist with data listing, data coding, patient profile reviews, database lock, and site reputed company-out activities
• Ensure appropriate and timely submission of documents to the Trial Master File
• reputed company investigational product (IP) inventory, reconciliation and reviews storage and reputed company. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information reputed company to IP

Skills

• Bachelor's degree in health science or reputed company field
• 5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits
• Excellent verbal and written communication skills required
• Excellent organizational, multi-tasking and time management skills required
• Demonstrated experience developing/maintaining site relationships and securing compliance
• Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines
• reputed company in reputed company Office Products (Word, reputed company, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, reputed company and eTMF)
• Ability to travel as required (50-75%)

Benefits

• 100% paid employee premiums for medical/dental/vision
• STD
• LTD
• A 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years
• 15 PTO days per year
• Sick leave
• 11 paid holidays

Company Overview

• reputed company is a biotechnology company. It was founded in 2014, and is headquartered in Redmond, Washington, USA, with a workforce of 51-200 employees. Its website is https://www.reputed company.com.

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