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Advanced Practice Provider

2 months ago


Maitland, Florida, United States Alcanza Clinical Research Full time
Advanced Practice Provider - Clinical Research Specialist

Department:
Operations

Employment Type:
Full Time

Location:
Alcanza Clinical Research

Reporting To:
Andrea Marraffino

Overview

Alcanza Clinical Research is a dynamic and expanding multi-site clinical research organization with a robust network across various states.

We are recognized for our extensive involvement in Phase I-IV clinical trials across diverse therapeutic areas, including vaccine development, neurology, dermatology, psychiatry, and general medicine.

We invite you to be part of our growth journey.


Role Summary

The Advanced Practice Provider will serve as a Clinical Research Specialist, acting as a Sub-Investigator in clinical trials. Under the guidance of the Principal Investigator (PI), the role includes conducting comprehensive medical assessments and supporting the PI in managing participant care throughout the study.

This position may also encompass responsibilities typical of a Clinical Research Coordinator, overseeing daily research operations in compliance with established protocols and regulatory standards.


Key Responsibilities
  • Perform duties as Sub-Investigator on clinical trials, ensuring adherence to IRB-approved protocols, informed consent processes, and participant safety monitoring.
  • Conduct research-related procedures, including physical examinations, injections, medical history evaluations, and monitoring of vital signs and laboratory results.
  • Engage in pre-study and site initiation visits, investigator meetings, and other relevant interactions.
  • Support site management in implementing change and enhancing operational processes.
  • Assist in training and mentoring new staff members.
  • Guide team members on study-specific tasks and responsibilities.
  • Ensure availability of necessary equipment for safety and compliance with health regulations.
  • Collaborate with the Principal Investigator to uphold high standards of quality and patient safety.
  • Maintain regular communication with sponsor representatives and all stakeholders involved in the research process.
  • Uphold confidentiality of all patient and company information in accordance with HIPAA regulations.
  • Stay well-informed about the research protocol, case report forms, informed consent, and study medications.
  • Adhere to GCP, ICH, HIPAA, NIH, and FDA regulations while maintaining current regulatory documentation.
  • Commit to ongoing professional development and growth.
  • Perform additional duties as assigned.

Qualifications

Applicants should possess a Bachelor's degree along with a minimum of two years of clinical experience, or an equivalent combination of education and experience. A valid license to practice as an advanced practice professional in the relevant state is mandatory. Prior research experience is highly desirable. BLS/ACLS certification is required, and bilingual proficiency in English and Spanish is advantageous.


Required Skills
  • Proficient in Microsoft Office applications, electronic health records, and web-based tools.
  • Ability to type at least 40 words per minute.
  • Experience in performing basic clinical procedures such as measuring blood pressure, conducting EKGs, and administering injections.
  • Strong organizational skills with a keen attention to detail.
  • Excellent written and verbal communication abilities.
  • Effective interpersonal skills and the capacity to work independently as well as collaboratively.
  • Adept at managing multiple tasks and adapting to changing priorities.
  • Demonstrates professionalism, respect, self-motivation, and a strong work ethic.
  • Exhibits integrity and reliability in all professional interactions.
  • Capable of working with minimal supervision and resolving issues proactively.
  • Ability to handle sensitive information confidentially and in compliance with HIPAA guidelines.

Benefits
  • Full-time employees working a minimum of 30 hours per week are eligible for benefits, with coverage commencing on the first day of the month following the date of hire.
  • Comprehensive benefits package includes medical, dental, vision, life insurance, short and long-term disability, health savings accounts, supplemental insurance options, and a 401k plan with a safe harbor match.