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Velocity Clinical Research, Inc. · 3 hours ago

Senior Clinical Research Coordinator

Los Angeles, CA

Full-time

Onsite

Mid, Senior Level

$70K/yr - $85K/yr

4+ 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 Senior Clinical Research Coordinator will lead clinical trial teams, mentor staff, and ensure compliance with protocols while managing all aspects of clinical trials.

Pharmaceutical

Responsibilities

Serve as leader of a study team to execute clinical trials

Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills

Create training strategies and mitigation plans

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

Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries

Ensure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team members

Develop communication and escalation strategies within teams to that 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

Ensure the creation, collection and submission of 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 in conjunction with patient recruitment staff

Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol

Incorporate understanding of how decisions affect the bottom-line including links between operations and company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol

Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol

Develop Quality Control strategies for team member projects

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

Understand the disease process or condition under study

Other duties as assigned

Qualification

Clinical trial managementGCP complianceRegulatory document submissionPhlebotomyProject managementAdvanced communication skillsTeam playerDetail orientedProblem solvingMentoring

Required

Bachelor's degree and 4 years as a Clinical Research Coordinator OR

Associate's degree and 6 years as a Clinical Research Coordinator OR

High School Graduate and/or technical degree and 8 years as a Clinical Research Coordinator

Phlebotomy if applicable and required by state law Intravenous/Intramuscular dose administration and preparation if applicable and required by state law Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role

Advanced 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

Advanced verbal, written, and organizational skills

Advanced interpersonal and communication skills

Advanced ability to work as a team player

Advanced ability to read, write, and speak English

Demonstrated ability to multi-task

Advanced ability to follow written guidelines

Demonstrated ability to work independently, plan and prioritize multiple deliverables and objectives

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

Must be detail oriented