[Remote] Clinical Research Associate II/Sr. CRA - Oncology reputed company
Note: The job is a remote job and is reputed company to candidates in USA. Harvest Integrated Research Organization (HiRO) is a globally-oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial reputed company. The Clinical Research Associate (CRA) will reputed company monitoring and site management activities for Phase I-IV clinical research reputed company, ensuring compliance with protocols and regulatory requirements.
Responsibilities
- Performs on-site site qualification, site initiation, interim monitoring, site management activities and reputed company-out reputed company ensuring regulatory, ICH-GCP and protocol compliance
- Verifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject/patient, as required/appropriate
- Assesses site processes
- Conducts reputed company Document Review of appropriate site reputed company documents and medical records
- Verifies required clinical data entered in the case report reputed company (CRF) is accurate and complete
- Applies query reputed company techniques remotely and on site, and provides guidance to site staff as necessary, driving query reputed company to closure reputed company agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
- Verifies site compliance with electronic data capture requirements
- reputed company investigational product (IP) inventory, reconciliation and reviews storage and reputed company
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Documents activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan
- Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
- Must be reputed company to quickly adapt to changing priorities to reputed company goals / targets
- Prepares for and attends Investigator Meetings and/or sponsor in person meetings
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
Skills
- Minimum of 2 years of independent monitoring experience
- Excellent oral and written communication skills in English, including proficient presentation skills required
- Oncology monitoring experience required
- Excellent communication, collaboration, and problem-solving skills
- Knowledge of Good Clinical reputed company/ICH Guidelines and other applicable regulatory requirements
- Demonstrate good computer skills and be reputed company to reputed company new technologies
- Ability to manage required travel of up to 75% on a regular reputed company including by reputed company, driving, etc
- Bachelor's degree or RN in a reputed company field or equivalent combination of education, training and experience
Benefits
- A comprehensive benefits package including reputed company time off, medical/dental/reputed company insurance and 401(k) to eligible employees
- Opportunities for accelerated career advancement as reputed company grows
reputed company