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Nurse Practitioner or Physician Assistant - Sub-Investigator (Must be Bi-lingual - English/Spanish). Nurse Practitioner or Physician Assistant.

Job Description JOB TITLE: Clinical Research Coordinator REPORTS TO: Research Executive Director FLSA STATUS: Exempt GENERAL DUTIES • Perform work independently under the general guidance of a supervisor., • Create and/or maintain all documents and records related to the study., • Ongoing visits and correspondence with study participants to monitor the condition of patients and collect study data., • Careful documentation of participant data per study guidelines. Maintains study records in a timely and detail-oriented fashion., • Create study specific documents (telephone screen questionnaire, source documents, site-level and master-level general logs, intake forms, etc.)., • Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol., • Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings., • Responsible for accurate and timely data collection, documentation, entry, and reporting., • Participates in required training and education programs. Participates in education and awareness of clinical research/active studies to clinical staff., • Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality., • Communicates with the physician regarding study requirements, need for dose modification, and adverse event reporting., • Ensuring that the necessary supplies and equipment for a study are in stock and in working order., • Manage the inventory of equipment, supplies, and laboratory kits and order more as needed., • Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur., • Knows the contents and maintenance of study-specific clinical research regulatory binders., • Receives supply and IP orders/shipments and confirms accuracy of delivery. This includes logging and storing the IP as per protocol and procedures., • Recruits and screens potential study participants and performs intake assessments., • Collects and processes laboratory specimens per protocol., • Sound knowledge of collection procedures for central and local laboratories., • Inputs data and patient information into electronic systems., • Administer questionnaires., • Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants., • Identifies, reports, and helps problem-solve protocol deviations and unanticipated occurrences., • Engage with study monitors and prepare for interim monitoring visits., • 2+ years of previous experience working in a research setting., • Excellent written and verbal communication skills., • Superior organizational and time management skills., • Capable of working independently with minimal supervision and also as part of a team., • Skilled with standard computer programs, including the MS Office suite., • Understanding of medical terminology as well as standard clinical procedures and protocols., • Attention to detail and the ability to accurately collect and record data., • Knowledge of good clinical practice (GCP) guidelines and regulations governing clinical research., • Proficiency in relevant computer software and electronic data capture systems., • Compensation depends on experience., • See benefits package for full list of benefits. Hours of work: Full-time position Monday - Friday; hours may vary based on the current needs of the company. Schedule will be based on a 40-hour work week. Overtime expectations: This position is not expected to have overtime. If overtime is expected, management will communicate with the Study Coordinator to adjust schedules with at least 2 weeks' notice. Work environment: Ability to lift up to 20 pounds for a short period and capable of standing for extended periods of time. Travel requirements: This position requires travel to the additional RASF/Gastromed locations if needed. Reporting To • 90-day probationary period upon commencement of employment, • Yearly evaluation with Vice President and Executive Director Employee Health Ins is covered at 100%. We also offer Dental, Vision, Life and 401K Benefits.