Job Description

Looking for a strong Clinical Research Coordinator to join our team!

Schedule : M-F, 8-5; Need someone with flexible availability for evenings/weekends outside of normal work hours

Summary:

The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and SOPs.

Responsibilities

Duties/Responsibilities:

• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and SOPs
• Implement and coordinate assigned clinical trials including start up, vendor management,subject recruitment, source development review, scheduling subjects, protocol training,collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
• Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors.
• Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Maintain confidentiality of patient protected health information, sponsor confidential information
• Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and SOPs.
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
• Ensure staff are delegated and trained appropriately and documented
• Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
• Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
• Create and execute recruitment strategies defined by Clinical Research Team
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• Understand product development life cycle and significance of protocol design including critical data points
• Understand the disease process or condition under study
• Collaborate with Clinical Research Team to develop Quality Control strategy for reviewing ones work on an ongoing basis and in preparation for monitor visits.
• Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG,lab processing) within scope
• Other duties as assigned

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