Clinical Research Coordinator
Role: Team LeadCompany: ICON
Job description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Title: Clinical Research Coordinator Location: On-Site San Antonio TX Job Type: Full Time, Permanent Duties: • Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance. • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. • Familiarize, understand, and apply all ICON standard operating procedures (SOP’s) applicable to job description • Travel (approximately 0%) domestic and/or international. • Participate in the early planning phases of clinical study by providing assistance to the Study Manager as appropriate to ensure that appropriate timelines are being met as to meet contractual obligations and study team timelines. • Evaluate, coordinate and ensure the completion of all protocol relates task to include: Development of Informed Consent, source documents, study related forms, procedural timelines and review of Lab packets and any other forms that may be needed or used in the clinical research process in relation to the project. • Obtain input from the appropriate staff as it pertains to the development of the above documents. Coordinate QC efforts of all documents and finalization of documents with Study Manager or applicable departments. • Coordinate and assist Regulatory Coordinator to ensure timely submission of regulatory documents to the IRB as outlined in the study timeline. Ensure any amendments are safety reports are submitted in a timely matter to the coordinator for additional submissions if applicable. . • Coordinate with Regulatory Coordinator the initiation of the site signature log. • Maintain and update regularly the clinical study enrolment log, deviation logs, study status logs (revenue and forecasting), stipend payments submissions – these duties can be delegated to the Research Assistant • Coordinate with Study or Project Manager to provide requested information for interim status report to sponsor. • Attend meetings with Sponsors for assigned protocol. • Participate in meetings to include (SIV, Internal/External Kick-off Meetings, Clinical Tracking or any ad hoc meetings that may occur for the project). • Lead and coordinate project specific interdepartmental start up meetings, (screening/recruitment, mock runs if applicable, Clinical Start-Up Meeting, Project Specialized Training) to ensure that all clinical staff is trained on the protocol and study specific procedures. • Coordinates with Study Manager, Screening and Recruitment to maintain timely execution of study enrolment. • Host and participate in monitor visits • Coordinate with the Study Manger and Data Coordinator timelines to ensure that data entry is met per the contractible timeline. • Assist and work with the Data Coordinator to assure a timely resolution of all queries (internal QC report, monitor reports, data queries etc.). • Assist in dosing and oversight of your clinical project while in the CPU. • Assist in ensuring that all documents and materials needed for outpatient visit are available for the department responsible for carrying out the procedures. • Carry out clinical study directives from the Principal/Sub Investigator. • Understand protocol requirements and communicate those requirements to applicable staff. To be successful, you will have: • Bachelor's Degree preferred • Minimum of 2 years medical / healthcare experience • Clinical research experience preferred • Excellent written, oral, and interpersonal skills • Detail oriented with excellent organizational skills • Proficiency with Microsoft Office • Self-starter with ability to work independently as well as on a team • Leadership skills Benefits of Working in ICON: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Requirements
• Minimum of 2 years medical / healthcare experience
• Excellent written, oral, and interpersonal skills
• Detail oriented with excellent organizational skills
• Proficiency with Microsoft Office
• Self-starter with ability to work independently as well as on a team
• Leadership skills
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Date Posted
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