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Velocity Clinical Research, Inc. · 3 hours ago

Clinical Research Coordinator II

United States

Full-time

Onsite

Entry, Mid Level

$30/hr - $36/hr

2+ years exp

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. 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 Velocity’s SOPs.

Pharmaceutical

Responsibilities

Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s 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 and Velocity 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 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 pre-screens

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 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

Qualification

Clinical trial managementGCP knowledgeProject managementMedical terminologyRegulatory document submissionData entryProblem solvingCommunication skillsTeam playerDetail orientedLeadership ability

Required

Bachelor's degree and 2 years relevant experience in the life science industry OR

Associate's degree with 4 years relevant experience in the life science industry OR

High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year Clinical Research Coordinator experience

Demonstrated knowledge of medical terminology

Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone

Proficient ability to work in a fast-paced environment

Proficient verbal, written, and organizational skills

Proficient interpersonal and communication skills

Proficient ability to work as a team player

Proficient ability to read, write, and speak English

Proficient ability to multi-task

Proficient ability to follow written guidelines

Proficient ability to work independently, plan and prioritize with minimal guidance

Proficient ability to be flexible/adapt as daily schedule may change rapidly

Must be detail oriented