Clinical Research Coordinator I

• Overview Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites.
• At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients.
• We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
• As an employee of Velocity, you are the most integral part of our mission.
• For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance.
• Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
• Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Summary

The Clinical Research Coodinator I conducts and manages clinical trials in accordance with the study protocol,GCP, and Velocity’s SOPs.

Responsibilities

Duties/Responsibilities: Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s 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 Velocity 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 Velocity 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.