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 or Manager, 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:
HS graduate and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task 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 the completion of essential tasks by deadlines.
Demonstrated ability to exercise tact and discretion in sensitive communications with patients and others. Demonstrated ability in handling a variety of confidential information appropriately.
Demonstrated positive interpersonal skills and problem solving abilities.
Willing to travel (limited travel for investigator meetings)
Preferred Qualifications:
Experience in clinical cardiology and clinical/cardiovascular research
Science, research, or medical background
Applied knowledge in drug and/or device trials
A two-year commitment is preferred
Proficiency in the use of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.
Understanding of patient population to create rapport, while also giving insight to what is realistic and appropriate for patient participation.
In-depth knowledge of ICH/GCP and FDA requirements for INDs, IDEs, and NDAs.
Experience in 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 for dealing with reimbursement, guidelines for research, confidentiality and HIPAA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
Experience applying the following regulations and guidelines:
Good Clinical Practice Guidelines
Health Information and Accountability Act (HIPAA)
The 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:
No
Numbers & Facts
Location
San Francisco, CA
Skills
Cardiologyunmatched
Cardiovascularunmatched
Clinical Researchunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Data Managementunmatched
Database Analysisunmatched
Detail Orientedunmatched
Electronic Medical Recordsunmatched
Environmental Healthunmatched
Epic Systemsunmatched
Establish Prioritiesunmatched
FDA Requirementsunmatched
Fire Safetyunmatched
GCP (Good Clinical Practices)unmatched
HIPAA (Health Insurance Portability and Accountability Act)unmatched
IBM SPSS Statistical Packageunmatched
ICH Regulationsunmatched
IDE (Integrated Development Environment)unmatched
Interpersonal Skillsunmatched
Life Safety Systemsunmatched
Medical Recordsunmatched
Medical Researchunmatched
Medical Terminologyunmatched
Medicineunmatched
Multitaskingunmatched
New Drug Applicationunmatched
Order Picking/Packingunmatched
Organizational Skillsunmatched
Patient Chartsunmatched
Patient Confidentialityunmatched
Patient Safetyunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Regulationsunmatched
Reimbursement Guidelinesunmatched
Research Protocolsunmatched
Safety Processunmatched
Safety Trainingunmatched
Safety/Work Safetyunmatched
Scientific Researchunmatched
Society of Clinical Research Associates (SoCRA)unmatched
Time Managementunmatched
Training/Teachingunmatched
Translational Researchunmatched
Willing to Travelunmatched
Writing Skillsunmatched
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