Clinical Research Coordinator I - Non RN

Responsible for all study management tasks for studies in which they are assigned to as the Primary Coordinator. This is not an exhaustive statement of duties, responsibilities, or requirements. Employees will be required to perform any job, with related instruction given by their supervisor, subject to reasonable accommodation.

Acts as a liaison between the Principal Investigator (PI), Institutional Review Board (IRB), other hospital departments, and study participants for study management. Provides study information to physicians, nurses, pharmacists, and lab personnel. Arranges in-service trainings as appropriate. (40%) Assists physicians in identifying eligible patients and in the informed consent process.

Depending on study, may perform informed consent process. Coordinates all research activities of study participants, identifies lab work necessary for each study, and oversees study drug administration. Monitors and reports adverse events according to IRB and protocol guidelines. Depending on study, may implement a system for obtaining, labeling, processing and shipping specimens in collaboration with the lab and hospital units.

(30%) Submits required documentation to IRB including opening/closing of studies, informed consent documents, and amendments and renewals of study protocols. Assists Principal Investigator in identifying potential sponsors/studies. (25%) Responsible for study drug/device accountability, including ordering study drugs/devices, distribution/dispensation of study drugs/devices, and when appropriate, maintaining study drug/device accountability records and returning unused study drug/device to sponsor.

(5%) All job qualifications listed indicate the minimum level necessary to perform this job proficiently. LEVEL OF EDUCATION Minimum: Bachelor's Degree in biomedical or healthcare related field or Bachelor's Degree in unrelated field with relevant research experience. CERTIFICATIONS, LICENSES, REGISTRATIONS Minimum: Must attain certification listed in preferred by 3rd year to maintain job position.

Upon hire Preferred: Certified Clinical Research Professional (CCRP), Certified Research Coordinator (CRC), or Certified Clinical Research Coordinator (CCRC) TECHNICAL REQUIREMENTS Minimum: Excellent communication and writing skills. Basic Microsoft Word, Excel, PowerPoint, and Outlook skills. Preferred: Familiarity with HIPAA regulations and regulations governing human subjects in research.

Demonstrated knowledge and understanding of the IRB process. Working knowledge of scientific and medical concepts and terminology, and strong familiarity with biomedical research protocols. YEARS OF RELATED WORK EXPERIENCE Minimum: 6 months of experience in research/healthcare environment (i.e. academic research experience) Preferred: Two or more years of research experience.

KNOWLEDGE, SKILLS, and ABILITIES All knowledge, skills, and abilities listed indicate the minimum level deemed necessary to perform this job proficiently. Capable of working independently with minimal direction. Able to comprehend guidelines of clinical trial protocols with general guidance from physician investigator(s).

Effectively work with frequent interruptions, multi-task, and pay attention to extreme detail. Possess strong follow-through skills. Strong interpersonal skills, including diplomacy, dependability, empathy, a positive attitude and conscientiousness. Ability to work with both children and adult study participants, colleagues and community.

Excellent verbal and written communication skills that reflect a positive attitude and a sense of commitment to our patients, work associates and community. Excellent organizational skills