Sr. Clinical Research Associate

Job description

Job responsibilities

• Contribute to all clinical research activities to ensure the successful start-up and management of clinical studies through FDA approval.
• Maintain and track clinical study data monitored and help in Investigator, Sub-Investigators qualification and selection, training, scrutiny of potential patient recruitment, and overall study status/progress…
• Co-Management of site start-up/activation process, including heavy contribution to the preparation of study-related documents and complete checklists, able to help with clinical trial agreements and budget negotiation,…
• Assist with eCRFs/EDC system, CTMS, eTMF and imaging Core Labs.
• Assist with review of IRB submissions, consents and applicable regulatory documentation with follow-through to ensure successful outcomes.
• Assist with amendments clinical study documents (ICF, CRFs, protocols, Monitoring Plan, study tools, etc.) as needed and assist clinical sites with institutional review board submission if necessary.
• Experienced with performing on-site and/or remote site qualification visits, site initiation visits, interim co-monitoring visits, and site close-out visits with or without the CRO.
• Conduct clinical study co-monitoring to ensure regulatory and protocol compliance and overall data accuracy in accordance with the study clinical monitoring plan.

Job requirements

• Previous experience implementing pharmaceutical trials. Significant knowledge of clinical and/or outcomes research study design. Experience with surgical trials is preferred.
• Possess advanced knowledge of Clinical investigation of investigational drugs for human subjects.
• Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements.
• Clinical research/clinical trial management certification/education preferred.
• Excellent ability to interact with physicians and other professionals inside and outside the company.
• Excellent communication skills.
• Experience with protocol and ICF development, and related amendments.
• Experience negotiating clinical research contracts and budgets.