The posting
Job Description
**This position is a Limited Appointment for one year**
Under the supervision of the Principal Investigator (PI), the incumbent will perform entry-level duties related to the support and coordination of clinical studies and may receive training and development to prepare and advance for journey-level work at the next level within the series.
May be responsible for the coordination of one or more single or multi-site, active or follow-up clinical studies or trials; help prepare protocols for study initiation; help design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding clinical trial subjects; may apply understanding of inclusion/exclusion eligibility criteria for protocols; help recruit, consent, enroll, register, schedule and retain study subjects; and assure collection and shipment/transport of samples; assist research personnel to keep patients on study schedules if needed; complete study forms to submit to sponsors and/or appropriate funding agencies; collect, enter and clean data into study databases, maintaining data quality; assist with data analysis; assist with preparation of reports and tables; attend team meetings; and perform other duties as assigned.
UCSF Dermatology is a global leader providing outstanding care for patients with skin disease, training the next generation, advancing innovative research, and advocating for the health of our communities. We rank among the world’s top centers for skin research. We have over 20 research faculty working on cutting-edge research that spans fundamental skin biology to clinical trials. Our programs address key problems in skin biology and disease at the levels of the basic, translational, and clinical sciences. Our research faculty are also engaged in innovative work in public policy, public health, and epidemiology.
Responsibilities
%
of time
(Nothing less than 5%)
Essential Function (Yes/No)
Key Responsibilities
(To be completed by Supervisor)
40%
YES
Patient Management
Working in collaboration with others, schedules and tracks patient visits, tests, procedures and follow up according to protocol; provides calendars and schedules to patients; obtains insurance authorization for tests/procedures; in collaboration with team members, codes and documents toxicities and adverse events; reports adverse events to appropriate University and outside agencies; obtains, processes and ships specimens.
10%
YES
Patient Registration
Works with Investigators to verify history and medical information to assure inclusion/exclusion criteria are met; schedules screening tests and procedures;
registers and randomizes patients on trials and/or studies.
30%
YES
Data Management
Abstracts clinical data from medical records or other databases; enters data onto case report forms, study flow sheets, and other forms; submits required data and data forms in accordance with accuracy and timeliness requirements of the protocols; addresses and resolves data queries; identifies, investigates and resolves data quality issues
20%
YES
Miscellaneous
Helps prepare for audits/monitoring visits by sponsors and/or regulatory agencies;
Monitors study supply inventory and reorders as needed; maintains research charts and study binders; and performs other related duties as assigned.
100%
(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)
Qualifications
Required Qualifications:
- High School Diploma; or equivalent experience
- Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team
- Attention to details
- Proficiency with Microsoft Word, PowerPoint, and Windows
- Excellent analytical and problem-solving skills
- Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects
- Ability to establish cooperative working relationships with patients, co-workers, & physicians
Preferred Qualifications:
- Demonstrated proficiency with medical terminology
- Experience working with patients or study subjects
- Ability to abstract data from medical records and transfer it to data collection forms or directly into databases
- Fluency in the usage 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 and a relationship, while also giving insight to what is realistic and appropriate for patient participation
- Experience with electronic medical records
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA 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: RedCap, Stata, and/or R programming platforms
- 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 Safety Training
