Clinical Research Specialist

2 weeks ago

Miami, United States Quotient Sciences Limited Full time

About Quotient Sciences
Quotient Sciences is a leading accelerator in drug development and manufacturing, offering comprehensive programs and customized services throughout the entire development process. By breaking down barriers across various drug development capabilities, we assist biotech and pharmaceutical clients in efficiently bringing medications to patients.

With a dedicated workforce of over 1,300 professionals globally, we operate from advanced development, manufacturing, and clinical facilities in both the UK and USA. Our core values—Science, Agility, and Culture—drive our mission, allowing us to innovate and transform ideas into viable solutions and molecules into effective treatments swiftly.

Position Overview

  • Oversee, coordinate, and monitor study activities, including managing adverse events and administering study medications.
  • Ensure compliance with Good Clinical Practice (GCP) guidelines and relevant regulations.
  • Maintain high-quality data collection in alignment with GCP standards.
  • Prioritize subject safety throughout the study.
Key Responsibilities
  • Administer study medications to participants.
  • Utilize intravenous infusion techniques, including the use of pumps.
  • Supervise staff and study events in accordance with protocol requirements, adjusting staffing as necessary.
  • Monitor study timelines and evaluate study activities as they unfold.
  • Document and address adverse events appropriately.
  • Ensure that all necessary documentation, including informed consents and lab results, is prepared for each participant's admission.
  • Oversee clinical results and compliance, identifying issues that may necessitate participant exclusion or discontinuation.
  • Engage effectively with pharmaceutical representatives and clinical research organizations during the study.
  • Participate in essential study meetings, including site initiation visits and clinical kick-offs.
  • Ensure timely availability of all required source documents on-site.
  • Review study documents for accuracy and completeness.
  • Be familiar with emergency procedures and respond to medical emergencies as needed.
  • Assist with nursing duties as required.
  • Support the training of new employees by providing orientation on study procedures and responsibilities.
Candidate Profile
  • Bachelor of Science in Nursing (BSN) or Registered Nurse (RN) with experience in critical care or clinical research settings.
  • Possess a valid nursing license.
  • Hold current Advanced Cardiac Life Support (ACLS) certification.
  • Fluency in English and Spanish is preferred.
  • Proficient in Microsoft Office applications.
  • Exhibit high attention to detail.
  • Demonstrate excellent communication and interpersonal skills.
Commitment to Diversity, Equity, and Inclusion
Quotient Sciences is dedicated to fostering a diverse workforce and creating an inclusive workplace culture. We value the importance of representation and strive to reflect the diversity of society in our organization.

We do not discriminate based on any characteristic protected by law, including race, gender, age, disability, and more. This commitment applies to all employment aspects, including hiring, promotion, and training.

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