Healthcare - Clinical Study Specialist IV

Job Description : 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.

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