Registered Nurse (Clinical Research)
Location
Covington, LA | United States
Job description
Are you a Registered Nurse looking for career advancement? THIS IS IT! Amazing opportunity to break into the Clinical Research industry and work on ground breaking research. Previous experience within clinical trials NOT needed, just well versed RN with great clinical skills. Apply today!
Hourly rate and annual bonuses!! Summary: - The Clinical Research Coordinator II/Research Nurse conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and SOPs.
Responsibilities
Role & 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 timelymanner and all queries are resolved, managing and reporting adverse events, serious adverseevents, and deviations, implementing new protocol amendments, providing all close outreports.
- Apply project management concepts to manage risk and improve quality in the conduct of aclinical research study
- Develop, coordinate, and implement research and administrative strategies to successfullymanage 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 tosponsor/CRO data capture systems and resolving queries
- Maintain confidentiality of patient protected health information, sponsor confidentialinformation and company confidential information
- Verify and escalate patient safety concerns by ensuring all adverse events, serious adverseevents, and adverse events of special interest are followed and reported in accordance withthe protocol and SOPs.
- Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timelymanner
- Ensure staff are delegated and trained appropriately and documented
- Create, collect and submit regulatory documents to Sponsors and IRBs as required perprotocol, 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 eachassigned protocol.
- Understand product development lifecycle and significance of protocol design includingcritical data points
- Understand the disease process or condition under study
- Collaborate with Clinical Research Team to develop Quality Control strategy for reviewingone's 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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Job tags
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