Clinical Research Associate II

Avania's Clinical Research Associate II (CRA II) establishes, maintains and supports clinical trials. Through the monitoring process, you will verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Further, you will ensure that the conduct of the trial follows approved protocols/amendment(s), with ISO14155 or ICH-GCP, and with applicable regulatory requirements.

Clinical Trial Monitoring

• Oversee clinical trial activities at investigational sites with a focus on Site initiation visits - SIV (will require travel to investigational sites)
• Conduct and write accurate visit reports in accordance with SOPs and GCP, including pre-study, site initiation, routine monitoring, and close-out visits
• Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols
• Ensure data entered on the CRFs by investigational sites is performed in a timely manner and verify that data is consistent with patient clinical notes, known as source data/document verification (SDV)
• Collaborate with analytical services as appropriate, to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data
• Monitor sites' completion of action items between visits

Study-Specific Documents and Files

• Prepare for audits and inspections
• Participate in internal TMF reviews
• Review and write informed consent forms
• Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development

Regulatory Affairs

• Prepare submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and assist in administrative tasks for submissions
• Prepare confidentiality agreements and complete templates of clinical trial/investigator agreements
• Prepare annual trial progress reports for IRBs/ECs and CAs/FDA under supervision
• (Assist in) reporting Serious Adverse Event to Sponsor, IRBs/ECs, CAs/FDA and investigators

Additional Responsibilities

• Participate in project meetings and investigator meetings; write and publish minutes
• Perform submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and follow-up until approval is obtained
• Prepare clinical trial agreements and discuss/negotiate between site and Sponsor

Skills & Other Requirements

CRA IIs require skills in planning and preparation; sourcing and collecting information; prioritizing tasks and actions; and displaying a proactive attitude to assist in project planning and study execution.