Clinical Research Specialist I

General Summary
Under minimum supervision, coordinates clinical research studies, including recruiting and enrolling study participants. Maintains research study documentation. Completes Case Study Report Forms. Assists Principal Investigator and/or research team members in study procedures. Conducts data collection activities and prepares analytical reports regarding results of studies. Participates in writing articles and summary papers for various publications.

Principal Duties & Responsibilities

• Assists Principal Investigators PIs in planning and implementing clinical research studies as assigned.
• Under the direction of the PI, coordinates preparation of protocol applications for submission to the IRB, sponsor, or regulatory authority.
• As directed by the PI corresponds with the IRB, study sponsors, clinical research organizations, study participants, and referring physicians.
• Recruits study participants for enrollment in clinical trials. Follows individual study protocols.
• Completes informed consent procedures as assigned.
• Organizes strategies for recruiting study participants and screens study participants for eligibility on the telephone, in the clinic, and other settings as required.
• Completes follow-up with study participants in prescribed settings as required.
• Organizes study procedures and schedules study participants for study visits.
• Assists the PI during patient visits. Performs study procedures designated for the Study Coordinator.
• Completes record abstraction of source documents, conducts required study measurements, and completes study Case Report Forms in accordance with best practice methods.
• Conducts a QC check of completed CRFs prior to submission for data entry; coordinates resolution of all data queries.
• Completes data entry as warranted.
• Complies with all institutional policies and government regulations pertaining to human subjects' protections.
• Maintains regulatory binders, case report forms, source documents, and other study documents.
• Monitors the occurrence of clinical adverse events, reporting any to the PI, the study sponsor, and Committee on Clinical Investigations IRB. Updates protocol and amendment changes. Assists investigators in data and/or document preparation for journal publication.
• Performs literature searches and pulls articles.

Knowledge, Skills and Abilities

• Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.
• Well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions.
• Advanced writing skills.

To qualify, you must have:

• A Bachelor's degree and three years of relevant work experience.
• Master's degree is preferred with one year of relevant work experience.