Clinical Research Coordinator - 247214

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

This opportunity is a 6 month contract to hire (based off performance / attendance)

Full-time Monday - Friday (40 hours a week)

Summary :

The Clinical Research Coodinator I conducts and manages clinical trials 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
• Coordinate, with supervision, 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.
• 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 and confidential information
• Ensure patient safety is upheld and 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.
• Execute recruitment strategies defined by Clinical Research Team
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
• Promote respect for cultural diversity and conventions with all individuals.