GENERAL PURPOSE:With direction from the Clinical Research Manager, assists with coordination of clinical research management activities for large international multi-site studies within the Clinical Cardiology Research Center to be consistent with Good Clinical Practice, applicable federal regulations, and standard study-specific operating procedures.JOB DUTIES AND RESPONSIBILITIES:
Processes receipt of applicable startup paper and electronic regulatory documents for clinical trials, including but not limited to, personnel information, IRB approval, signed training, financial disclosure, electronic access, curriculum vitae, professional licensure, and certification of human subjects protection and good clinical practice education in internal electronic tracking system. Reviews documents received to confirm submission requirements met. Provides report summary to team regarding document collection status and contacts sites for missing or erred documents.
Participates in the development, implementation and evaluation of:
Studydesign,proceduremanuals,consentformsand case report forms
Procedures,protocols
Standard OperatingProcedures
Recruitmentstrategies
Patient and site instructions congruent with study protocol and procedures
Supply and equipment requirements
Extracts and maps clinical data from test data media and analysis reports, source documents, and test procedure reports with subsequent entry of collected data using various electronic data capture systems/databases Including problem resolution correspondence with enrolling sites.
Utilizes internal tracking system to monitor IRB, medical license and certification expiration and contacts sites to obtain renewals as appropriate to study work instructions.
Corresponds in writing and by phone with enrolling site personnel to obtain information for completing study data including media and source documents media resolving discrepancies using system and manually generated metrics data reports. Includes weekly correspondence with sponsors on QA and study data issues. Provides remedial training on protocols, procedures, documentation, and use of study materials to subjects and team members as appropriate.
Archives data media, event source documents, regulatory and correspondence documents with detailed tracking and appropriate document renewal to meet study-specific and regulatory requirements.
Develops site communication during study start up, study maintenance phase and close-out.
Assists with coordination of enrolling site training meetings and on-line study training sessions for research study personnel at all member institutions and training of enrolling sites.
Other Duties as assigned.QUALIFICATIONS:
Bachelor’s degree required.
Less than 1 year of experience in research; or equivalent combination of education and volunteer experience required.
Knowledge of word processing, spreadsheets, and electronic data capture (EDC) software preferred.
Excellent interpersonal and communication skills, including writing skills preferred.
Strong attention to detail and organizational skills 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 ApplyAll applicants must apply online.EOE Minorities/Females/Protected Veterans/DisabledPay RangePay Range: $24.40 - $34.16 HourlyThe 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
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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
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