Title: Clinical Research Coordinator

Location: Clinical Pharmacology of Miami

Job Description:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late stage neuroscience drug development. With 21 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

The Clinical Research Coordinator participates in clinical research studies conducted by the Principal Investigator(s); performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical data. The Clinical Research Coordinator participates as a lead member of the clinical research team.

Responsibilities:

• Administration of study drugs as required by the specific protocol
• Ensures all study procedures are conduct as required by specific protocol (i.e. vital signs, draw blood, sample processing, sample shipping, etc)
• Assist in the capturing and reporting of adverse events, including serious adverse events
• Assist in the administration of the informed consent
• Maintains safety and well-being of study participants during assigned shift
• Monitors study events, meals, snacks and participants activities for assigned study protocol
• Verifies that participants are ready and that procedures commence on time
• Performs venipuncture, vital signs (including blood pressure, pulse, temperature, respiration), ECG, weight, height
• Assist staff and related medical staff with study participants care as requested, to include but not limited to, lifting patients, cardiopulmonary resuscitation, suctioning, bandaging, administering oxygen and other life saving measures as directed
• Clinical skills indicated by level of education, licensure, registration or certification
• Organize, train and supervise assistant clinical research coordinators, clinical supervisor and/or other designated staff in the proper implementation of study procedures and study conduct as indicated in study protocol
• Discuss and administer Informed Consent Form
• Ensure study data is collected following plan of care, guidelines and identified group resources
• Serve in rotation with other clinical research coordinators and/or assistant research coordinators
• Coordinates, prepares, and reviews all appropriate regulatory submissions within specified time-frame in conjunction with CPMI and the Sponsor
• Liaison between CPMI’s Regulatory Affairs and the Sponsor’s Regulatory division
• Reviews regulatory and related documents to ensure compliance

Educational:

• Maintains current licensure, registration and/or certification within educational background
• Maintains current BLS and/or ACLS certification
• Maintains necessary CEU’s for licensure, registration and/or certification
• Actively participates on CPMI’s ongoing Quality Assurance Program, HIPAA and Compliance Programs
• Keeps apprised of all new OSHA and GCP/ICH rules and regulations
• Attends all appropriate team meetings regarding study protocols
• Maintains skills in use of EKG machines, Holter hook-up and monitoring, diabetic monitoring and taking accurate vital signs
• Reads and understands CPMI policy and procedures manuals, SOP manual, and employee handbook

Skills and Qualifications:

• Education and experience

• A minimum of a high school diploma with 3 years research experience
• OR
• Professional Licensure, Registration and/or Certifications in a clinical or allied health field with a minimum of one year clinical research experience
• BLS and/or ACLS, phlebotomy and injection certifications preferred
• Clinical Research Coordinator Certification (CCRC) preferred but not required

• Requirements
  • Bilingual skills preferred but not required
  • Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • Excellent communication skills (interpersonal, written, verbal)
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)