Assistant Clinical Research Coordinator

Under the supervision of a Clinical Research Supervisor or 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 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, enroll, register, schedule and retain study subjects; record protocol specific treatments and assure collection and shipment of samples; assist research personnel to keep patients on study schedules; complete study forms to submit to sponsors and/or appropriate 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. 

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.

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. 

Data Management

Abstracts clinical data from medical records; 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

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

Required Qualifications:

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• 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