Research engineer Jobs in Chesapeake, VA

Company Description

Eximia Research is a fully Integrated research sites network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). Our premier, multidisciplinary wholly owned research sites located across country and known for excellent trial execution, rapid subject recruitment / enrollment and delivery of a quality data.

Job Description

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 Eximia Research Network’s SOPs.

Role & Responsibilities :

• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Eximia Clinical Network’s SOPs
• Perform venipuncture, capillary puncture and / or other fluid collection within scope of the protocol and local law and regulations
• Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
• 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 and participating in the ICF process(es), 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 outreports.
• 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 in accordance with ALCOA-C principles 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 and Eximia Clinical Network 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 Eximia Clinical Network SOPs.
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner as set forth in Clinical Trial Agreement
• 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 lifecycle 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 one’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

Qualifications

Education / Experience :

Required Licenses / Certifications :

Required Skills :