A clinical research nurse (also known as a Study Coordinator in the clinical research industry) is a professional who will coordinate and oversee clinical operations of research projects. This person will participate in assessing, planning, implementing and evaluating subject treatment and safety in clinical research studies and will comply with established clinical research organizational policies and procedures, as well as carry out research. This person will work under the general supervision of the Principal Investigator/Clinical Research Manager (PI/CRM) responsible for the clinical studies.
Duties and Responsibilities
Obtain and review records for potential research subjects; maintain study records of research subjects that include documentation of study procedures and progress of research study subjects, following guidelines set forth by the protocol sponsors.
Review recruited clinical study subjects for eligibility; schedule appointments and interviews, and evaluate potential subjects.
Instruct potential research subjects and responsible family members, nursing staff, and ancillary staff involved in research on the study procedures, treatments, and side effects.
Educate subjects concerning protocol and explain informed consent procedures, including HIPAA authorizations and obtain subjects’ written consent. Evaluate and assist in developing subject education materials and give subjects and/or family members instruction on test article administration and other study information.
Perform nursing assessments and monitor subjects' progress during clinical studies and notify PI/CRM of any adverse events and serious adverse events, including evidence of unexpected side effects. Perform initial interview during each subject visit and plan appropriate procedures according to the protocol.
Coordinate research activities and procedures for study subjects. Complete case report forms for each study participant and document study data in subject study file.
Assess and document compliance of research subjects.
Attend staff meetings/conferences as part of a study team.
Act as principal investigator's representative as appropriate.
Maintain subject database information. Work with analysts and assist with queries related to data to evaluate the significance of compiled data.
Attend research meetings and conferences as required.
Provide orientation, information, training/cross-training, and assistance for new/existing personnel and research assistants, study staff to the research activities.
Participate in staff meetings and in-service education.
Maintain adequate inventory of research supplies necessary for research activities. Maintain exam rooms and laboratory.
Licensed Practical Nurse (LPN) or Registered Nurse (RN)
One year of licensed or registered professional nursing experience
Excellent oral and written communication skills
High degree of empathy for subjects
Ability to work independently.
Strong problem-solving abilities
Understands OSHA guidelines for handling hazardous biological and chemical materials
**Must have Pediatric, OB-Gyn, geriatric, hospital experience.
***Varried hours 10-30 per week, sometimes up to 40