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Sr. Clinical Research Coordinator

Company: Medix---
Location: Chula Vista
Posted on: November 25, 2022

Job Description:

Medix is Hiring!
We are seeking a Sr. Clinical Research Coordinator to join a growing Site Management Organization (SMO) in the Chula Vista, CA area to join our team immediately.
Sr. Clinical Research Coordinator Position Summary:Coordinate all aspects of clinical research trials, ensures compliance with protocols, ensure regulatory compliance, liaison with monitors and sponsors, schedule visits for subjects and communicate effectively with Director of Clinical Operations /Site Director, Principal Investigators and Sub-Investigators. Must be able to work independently and handle multiple tasks. Must be able to work overtime if needed.
Sr. Clinical Research Coordinator Responsibilities:--- Serve as leader of a study team to execute clinical trials--- Mentor and train staff in the conduct of clinical trials, protocolrequirements, communication, and trial management skills--- Create training strategies and mitigation plans--- Conduct and manage clinical trials in accordance with the studyprotocol, GCP, ICH Guidelines and Velocity's SOPs--- Implement and coordinate assigned clinical trials including start up,vendor management, subject recruitment, source developmentreview, scheduling subjects, protocol training, collection of regulatorydocuments, conducting visits, ensuring data is entered in a timelymanner and all queries are resolved, managing and reportingadverse events, serious adverse events, and deviations,implementing new protocol amendments, providing all close outreports.--- Apply project management concepts to manage risk and improvequality in the conduct of a clinical research study--- Develop, coordinate, and implement research and administrativestrategies 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 memberswhen collecting and correcting data, transferring data tosponsor/CRO data capture systems and resolving queries--- Ensure confidentiality of patient protected health information, sponsorconfidential information and Velocity confidential information ismaintained by all team members--- Develop communication and escalation strategies within teams tothat ensure patient safety is upheld and all adverse events, seriousadverse events, and adverse events of special interest are followedand reported in accordance with the protocol and Velocity SOPs--- Ensure all data is entered into the sponsor's data portal and allqueries are resolved in a timely manner--- Ensure staff are delegated and trained appropriately anddocumented--- Ensure the creation, collection and submission of regulatorydocuments to Sponsors and IRBs as required per protocol, GCP/ICHregulations and IRB requirements.--- Evaluate potential subjects for participation in clinical trials includingphone and in person pre-screens.--- Create and execute recruitment strategies in conjunction with patientrecruitment staff--- Incorporate key timelines, endpoints, required vendors, and patientpopulation when planning for each assigned protocol.--- Incorporate understanding of how decisions affect the bottom lineincluding links between operations and company's financialperformance and how it is essential to create value of allstakeholders of the organization when planning for each assignedprotocol.--- Incorporate understanding of product development lifecycle andsignificance of protocol design including critical data points whenplanning 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 allindividuals.--- Understand the disease process or condition under study--- Other duties as assigned
Sr. Clinical Research Coordinator Qualifications: Education/Experience: --- 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 ClinicalResearch Coordinator
Required Licenses/Certifications: --- Phlebotomy if applicable and required by state law--- Intravenous/Intramuscular dose administration and preparation if applicableand required by state law--- Certified Clinical Research Coordinator through ACRP or SOCRA within sixmonths of being in the role
Required Skills:--- Advanced knowledge of medical terminology--- Proficient in the use of the following technology: Computers, MicrosoftOffice software, fax, copier, and multi-line telephone.--- Profcient 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 multipledeliverables and objectives--- Demonstrated ability to be flexible/adapt as daily schedule may changerapidly--- Must be detail oriented--- Proficient problem solving and strategic decision making ability.--- Advanced in accepting individual responsibility for actions taken anddemonstrating professionalism when judged, critiqued and/or praised.

  • --- Proficient leader, mentor and team builder

    Benefits:Full benefits coverage is offered. Should you elect to enroll, there are three levels of medical coverage to choose from, supplemental dental plans and term plans as well as the option to enroll your spouse and/or children. You can select the best combination that best suits your needs.
    401(k) Retirement PlanPaid time off benefits availableA limited benefit medical planDoctor visits with inexpensive co-payLimited Outpatient CareLimited Accident CoveragePrescription ProgramsDental PlanVision Discount ProgramTerm Life Insurance Plans
    Compensation: 60,000-80,000 annually
    Apply Today!

Keywords: Medix---, Chula Vista , Sr. Clinical Research Coordinator, Healthcare , Chula Vista, California

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