Clinical Research Associate II

Job Responsibilities

• Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits
• Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team to ensure efficient preparation and delivery of study materials to investigator sites
• Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug
• Affiliate 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 EDC 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
• Manage 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 all investigator and site correspondence
• Identify and complete follow-up of SAEs at study sites
• Affiliate with data listing, data coding, patient profile reviews, database lock, and site close-out activities
• Ensure appropriate and timely submission of documents to the Trial Master File
• Perform investigational product (IP) inventory, reconciliation and reviews storage and security. 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 related to IP

Qualifications

• Bachelor’s degree in health science or related field
• 2+ 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
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)
• Ability to travel as required (50-75%)

Pay

The expected base salary range for this position is $80,000 - $110,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.