Clinical Research Assistant

Alcanza Clinical Research•Palmetto Bay, FL

About The Position

The Clinical Research Assistant (RA) supports Clinical Research Coordinators, the Site Manager, Principal and Sub Investigators, and other site staff. The role performs clinical, laboratory, and administrative tasks needed to operate the clinical research site and support assigned studies, in compliance with GCP, ICH, HIPAA, FDA regulations, SOPs, and study protocols. Alcanza is a multi-site, multi-phase clinical research company conducting Phase I–IV studies across several therapeutic areas.

Requirements

High school diploma.
At least 1 year of administrative or clinical experience.
Proficiency with Microsoft applications, email, electronic health records, and web applications.
Ability to type at least 40 words per minute.
Strong organizational skills and attention to detail.
Well-developed written and verbal communication skills.
Well-developed interpersonal and listening skills; ability to work independently and with coworkers, subjects, managers, and external customers.
Ability to handle multiple tasks and adapt to changing workloads and priorities.
Professionalism, respect for others, self-motivation, and a strong work ethic.
High degree of integrity and dependability.
Ability to work with minimal supervision, identify problems, and implement solutions.
Ability to handle sensitive information confidentially and professionally in compliance with HIPAA guidelines.

Nice To Haves

One or more years of clinical research or clinical experience.
Bilingual proficiency in English and Spanish.

Responsibilities

Assist with assigned studies and site support functions in collaboration with the clinical research site team.
Support CRCs and other site staff under the direction of the Site Manager/Director and Principal/Sub Investigators.
Assist with basic screening of patients for study enrollment and patient follow-up visits.
Document information in source clinic charts.
Enter data in EDC and respond to queries.
Obtain vital signs and ECGs; may perform blood draws.
Perform protocol-directed laboratory procedures, including blood specimen collection, centrifuge operation, specimen storage and shipping, specimen accountability, and courier pickup coordination.
Request and track medical record requests.
Help update and maintain study logs and file documents and charts.
Schedule subjects for study visits, send appointment reminders, and reschedule visits when needed.
Ensure study-related reports and patient results are reviewed promptly by the Research Coordinator and/or investigator.
Assist the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed.
Maintain confidentiality of patient, employee, customer, and company information and adhere to HIPAA guidelines.
Perform other duties as requested or assigned.