Clinical Research Coordinator - Bilingual

Come work with a growing, multi-site clinical research team! Perfect for Research Assistants seeking a Coordinator-level role!

CLINICAL RESEARCH COORDINATOR

PURPOSE

To work as an integral member of the Rovia/Investigator site staff, maintaining the day-to-day operations and assist in the development of the Rovia network. This includes planning, coordinating, and executing clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor, CRO, and Rovia SOPs and any relevant local guidelines and regulations.

Responsibilities

Work directly as the patient/subject interface at research sites to deliver high-quality patient data in accordance with local regulations, agreed scope of work and as required by protocol.

• Attend and participate in investigator meetings, monitoring visits, audits, seminars and other regional or national meetings.
• Assist with screening and enrollment of subjects into assigned studies.
• Exhibit excellent customer service skills with trial subjects to encourage retention and future recruitment.
• Assist with the establishment of a recruitment and contingency plan for each study.
• Perform functions necessary for successful completion of all required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the investigator, in accordance with local county requirements.
• Complete source documents and case report forms accurately in both paper and electronic format.
• Assist investigator with recording and reporting of adverse events and SAEs per local regulatory authority guidelines.
• Perform other duties as assigned.
  
  

Required Knowledge, Skills And Abilities

• Sound knowledge of medical terminology.
• Sound knowledge of ICH/GCP and Regulatory requirements.
• Excellent interpersonal and organizational skills.
• Proficient in the use of Microsoft Office and Excel.
• Fluent in spoken and written Spanish and English.
• Ability to work independently and in a team environment.
• Ability to maintain confidentiality.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  
  

Minimum Required Education, Experience And Certifications

• Bachelor's degree or equivalent experience
• 1 years in clinical research required
• Regulatory experience strongly preferred
• Current CPR certification – can be provided upon hire
• International Air Transport Association (IATA) Certification – can be provided upon hire
• Good Clinical Practice (GCP) - can be provided upon hire
  
  

Job Type: Full-time

Benefits

• Paid time off
• Flexible schedule
• Advancement opportunities
• 401(k) with company match
• Health, dental, and vision insurance
• HSA with company match
• Life and disability coverage
• Employee referral program
• Referral program
  
  

Schedule

• Day shift
• Monday to Friday, 8:30AM-5:00PM
  
  

Work Location: Onsite at 9380 SW 150th St, Ste 140, Miami, FL 33176