Title: Principal Investigator

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 Principal Investigator assists and performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data; participates as a senior member of the clinical research team and may be listed as a Sub-Investigator on regulatory documentation.

Responsibilities:

Clinical:

• Takes/reviews subject’s medical history
• Perform physical assessments, as required
• Conducts subject physical examinations and records the data in the subject’s record
• Administer study drugs as assigned
• When assigned, serve as Pharmacy Custodian (Refer to Job Description for more details)
• Records drug relationship for all Adverse Events
• Documents subjects medical history and physical examination information
• Accurate maintenance of records with regards to the research project
• Administration of study drugs as required by the specific research project
• Actively participates on CPMI’s ongoing Quality Assurance Program, HIPAA, and Compliance Programs
• Maintains good knowledge and keeps appraised of all new OSHA and GCP/ICH guidelines, rules and regulations
• Attends all appropriate team meetings regarding study protocols
• Maintains current ACLS certification
• Maintain current Florida professional license
• Maintains necessary CEU’s for licensure

Skills and Qualifications:

• Education and experience

• Medical Doctor (MD) or Doctor of Osteopathy (DO) with current state of Florida licensure

• Requirements
  • Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • Bilingual skills are preferred but not required
  • 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)