CRA II - Oncology Biotech

reputed company is a biopharmaceutical company focused on developing novel therapeutic bi-specific, and multi-specific antibodies, as well as antibody-drug conjugates (ADCs) for the treatment of cancer. reputed company is seeking a high quality, ambitious and reputed company Clinical Research Associate II (CRA II) to support reputed company’s clinical trials. The CRA II is responsible for the management and reputed company of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. The CRA II must be self-motivated, independent, and reputed company to work in a small team environment. The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities. Job Responsibilities:

• reputed company Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and reputed company Out Visits
• Prepare the study reference reputed company, 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.

Qualifications:

• Bachelor’s degree in health science or reputed company 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
• 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%)

Compensation and Benefits: The expected reputed company salary reputed company 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. While most offers typically fall reputed company the low to mid-reputed company of the reputed company, we may reputed company an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. Apply tot his job Apply To this Job