Clinical Research Associate II
1 week ago
We are seeking a highly motivated and experienced Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for managing clinical studies at participating sites, ensuring the quality of site performance, and closing clinical studies.
Key Responsibilities:- Evaluate, initiate, monitor, and close out clinical study sites
- Document all activities in clear, comprehensive, and accurate Monitoring Visit Reports, Contact Reports, and follow-up letters within required timelines
- Ensure that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements
- Properly train/re-train site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial
- Serve as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members
- Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines
- Ensure subjects' rights, safety, and well-being are protected
- Ensure compliance with the procedures to apply in the event of adverse events and serious adverse events
- Evaluate the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion
- Assist and support data validation and data cleaning procedures to ensure timelines are met
- Identify, assess, and resolve site performance, quality, or compliance problems and develop an appropriate intervention plan for the avoidance of redundant errors and deviations
- Communicate with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance
- Maintain audit-ready clinical trial documentation. Collect, review, monitor, and file required regulatory documentation during study maintenance and at study closeout. Verify investigator study records are reconciled with the contents of Sponsor files (Trial Master File)
- Verify the receipt, handling, accounting, storage conditions, and availability of study medications under investigation
- Ensure availability of non-clinical materials for sites
- Develop strong site relationships and ensure continuity of site relationships through all phases of the trial
- Gain an in-depth understanding of study protocols and related procedures
- BA/BS, preferably in the Life Sciences, or RN
- Minimum of 2+ years of experience in the pharmaceutical/biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock
- Strong Oncology monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials
- Good understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA, and patient privacy laws, and other relevant, local regulatory requirements
- Good knowledge of concepts of clinical research and drug development
- Strong working knowledge of EDC, IVRS, and CTMS systems
- Proficiency in the use of Microsoft Office
- Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific, and medical information
- Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem-solving, attention to detail, and interpersonal skills
- Works with a high-quality and compliance mindset
- Possess a valid driver's license
- Must be willing to travel and spend 8-10 days/month on site
We offer a competitive salary and a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, a global Employee Assistance Programme, life assurance, and flexible country-specific optional benefits.
At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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