Human Subject Research Spec I

2 weeks ago

Rochester, United States University of Rochester Full time

Responsibilities General Purpose Human Subject Research Specialist I is an entry level clinical research coordinator responsible for coordinating the activities associated with human subject research. They will work under the supervision and guidance of the Principal Investigator (PI) and division research manager. This role will assume responsibility for less complex clinical research protocols, receiving guidance and instruction from senior level roles. Responsibilities Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others. Assists in Human Subject Screening Activities, Recruitment and Subject Visits Coordinates the administrative details required to initiate and conduct human subject research, such as, receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials Reviews study site patient databases and office records for patients that meet the protocol inclusion criteria. Screens potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment. Conducts visits to ensure research participant adherence with protocol requirements, Under supervision, maintains OnCore Database and Study Specific Research Logs Maintains logs including OnCore data entry, electronic medical records, according to UR and Department of Medicine Standard Operating procedures Assists in entering research data into study databases Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Communicates with Sponsor to clarify data queries to determine report format. Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits). Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training in provided to ensure changes to protocol and documents are communicated and adhered to. Complies with Good Clinical Practice (GCP) and Federal Regulations Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines. Demonstrates accountability for continuous learning in accordance with GCP guidelines. Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies and designs. Implements and monitors resulting study changes. Professional Development Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies Maintains CITI and other trainings/certifications as requires Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols Other duties as assigned Qualifications Bachelor’s degree required 3 years of experience in human subject research coordination required or equivalent combination of education and experience required Experience as Human Subject Research Coordinator I preferred Word processing and data analysis software required Professional Research Coordinator certification (SoCRA or ACRP) preferred The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations. How To Apply All applicants must apply online. EOE Minorities/Females/Protected Veterans/Disabled Pay Range Pay Range: $21.36 - $29.90 Hourly The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. Apply for Job Careers Sign In New User Location: Strong Memorial Hospital Full/Part Time: Full-Time Opening: Schedule:

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