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The Department of Medicine, Division of Cardiology, has developed a clinical research infrastructure within the Division. The goals are to increase industry-sponsored research, create a system that supports physicians in operationalizing investigator-initiated studies, and develop a general cardiology cohort study. The purpose of this position is to carry out tasks as part of ongoing and future clinical and translational research projects within the Division of Cardiology. Under the supervision of the Clinical Research Supervisor, the incumbent will perform duties related to the support and coordination of clinical studies and may receive training and development to prepare for advancement to the next level within the series. Required Qualifications: * High school graduate and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities * Attention to detail; strong interpersonal skills; excellent verbal and written communication skills to coordinate with subjects, team members, other departments, and outside institutions; and the ability to multitask in a fast-paced environment while working with a diverse subject population * Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure completion of essential tasks by deadlines * Demonstrated ability to exercise tact and discretion in sensitive communications with patients and others, including handling a variety of confidential information appropriately * Demonstrated positive interpersonal skills and problem-solving abilities * Willingness to travel (limited travel for investigator meetings) Preferred Qualifications: * Experience in clinical cardiology and clinical/cardiovascular research * Science, research, or medical background * Applied knowledge of drug and/or device trials * A two-year commitment preferred * Proficiency in the use of the Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols * Understanding of patient populations to build rapport and assess appropriate participation in research * In-depth knowledge of ICH/GCP and FDA requirements for INDs, IDEs, and NDAs * Experience building strong working relationships with sponsors, monitors, PIs, and other key stakeholders * Experience with electronic medical records (EPIC preferred) * Knowledge of biospecimen collection, processing, and transport * Knowledge of UCSF and departmental policies related to reimbursement, research guidelines, confidentiality and HIPAA regulations, the UCSF mission for research, and patient safety and confidentiality (including electronic and hard copy records, patient charts, and communication) * Knowledge of medical terminology, research policies and guidelines, shipping of infectious substances, database building/analysis, and data management using platforms such as Access, Stata, SAS/SPSS, and Teleform * Certification by the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP) * Experience applying the following regulations and guidelines: Good Clinical Practice (GCP) Guidelines Health Insurance Portability and Accountability Act (HIPAA) Protection of Human Research Subjects CHR regulations for recruitment and consent of research subjects Effective Cash Handling Procedures Environmental Health and Safety Training Fire/Life Safety Training License / Certification: * None Required Qualifications: * High school graduate and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities * Attention to detail; strong interpersonal skills; excellent verbal and written communication skills to coordinate with subjects, team members, other departments, and outside institutions; and the ability to multitask in a fast-paced environment while working with a diverse subject population * Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure completion of essential tasks by deadlines * Demonstrated ability to exercise tact and discretion in sensitive communications with patients and others, including handling a variety of confidential information appropriately * Demonstrated positive interpersonal skills and problem-solving abilities * Willingness to travel (limited travel for investigator meetings) Preferred Qualifications: * Experience in clinical cardiology and clinical/cardiovascular research * Science, research, or medical background * Applied knowledge of drug and/or device trials * A two-year commitment preferred * Proficiency in the use of the Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols * Understanding of patient populations to build rapport and assess appropriate participation in research * In-depth knowledge of ICH/GCP and FDA requirements for INDs, IDEs, and NDAs * Experience building strong working relationships with sponsors, monitors, PIs, and other key stakeholders * Experience with electronic medical records (EPIC preferred) * Knowledge of biospecimen collection, processing, and transport * Knowledge of UCSF and departmental policies related to reimbursement, research guidelines, confidentiality and HIPAA regulations, the UCSF mission for research, and patient safety and confidentiality (including electronic and hard copy records, patient charts, and communication) * Knowledge of medical terminology, research policies and guidelines, shipping of infectious substances, database building/analysis, and data management using platforms such as Access, Stata, SAS/SPSS, and Teleform * Certification by the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP) * Experience applying the following regulations and guidelines: Good Clinical Practice (GCP) Guidelines Health Insurance Portability and Accountability Act (HIPAA) Protection of Human Research Subjects CHR regulations for recruitment and consent of research subjects Effective Cash Handling Procedures Environmental Health and Safety Training Fire/Life Safety Training License / Certification: * None
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