The Clinical Research Associate II (CRA II) is accountable for conducting monitoring activities of clinical sites in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. He/she performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA proactively identifies, resolves/mitigates, and escalates risks and/or issues, must work independently with team support. When not traveling, the CRA II will conduct remote monitoring, maintain eTMF, ensure data entry, and query resolution for sites, SAE follow-up until resolution, and any other clinical activities to support the team.
?CRA II Accountability:
- Delivering high-quality, timely monitoring reports for Manager approval per Clinical Monitoring Plan timelines.
- Scheduling remote and in-person site visits for monitoring as required by protocol Clinical Monitoring Plan.
- Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at sites as dictated by trial protocol, ICH-GCP/ISO 141155, and company requirements.
CRA II Responsibilities:
- Learning and comprehending a complex Phase III oncology study protocol
- Answering protocol related questions and relaying questions to the study team from sites regarding the protocol
- Monitoring data with a focus on data integrity and patient safety per protocol and in accordance with regulations.
- Planning activities for study monitoring and setting priorities by site.
- Preparing for and conducting study initiation, interim monitoring, and close-out visits at investigator sites.
- Working with the in-house team to ensure that visit metrics are maintained as required.
- Gauging the quality of data and addressing quality issues with team members.
- Ensuring that the investigator and site staff are adequately trained on protocol requirements, the investigational product, regulatory and ethical obligations, and A/E and Serious Adverse Events (SAE) reporting.
- Ensuring SAEs are reported by the site according to the protocol; ensure full SAE reconciliation has been completed at the site level.
- Obtaining, reviewing for quality and completeness, processing and maintaining regulatory, ethics and essential documents from investigator sites.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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