Job Description

Job title- Clinical Study Specialist

Job location-Neenah, WI,54956

Contract duration-12 months contract-Possible to extend

Shift-Typical office hours are between 7am-4pm.

We are needing someone who is available AT LEAST 3 days a week (HIGHLY PREFERED they are available all 5 days, Monday-Friday).

Pay Rate-$38/h to $40/h

(lease note, hours could vary every single week as the schedule is based on business needs and not a set schedule. There is NO GUARANTEE this candidate will get a set 40 hours every single week, do not guarantee any set number of hours to candidates.)

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:

• L icensed 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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