Clinical Study Specialist IV

A Clinical Study Specialist is a professional who will coordinate and oversee clinical operations of research projects. This person will assess and evaluate subjects / subject safety. In compliance with established clinical research organizational policies / procedures, Good Clinical Practices plan, will conduct clinical research protocols. 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 obtaining 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.

If study requires instrumentation, set-up and verify instruments and conduct study with instruments. Assemble instrument data for study analysis

Troubleshoot simple equipment or instrumentation issues if necessary

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.

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.

Qualifications :

Licensed health care professional such as RN, LPN or radiological technologist.

One year of licensed or registered professional health care experience in a Clinical Research setting preferred.

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.