Assistant Clinical Research Coordinator

University of California, San FranciscoSan Francisco, CA

About The Position

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/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.

Requirements

  • HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities or equivalent training/experience
  • Excellent verbal and written communications and presentation skills
  • Excellent organizational skills
  • 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

Nice To Haves

  • Prior experience working on multi-site clinical high risk studies
  • Experience working with schizophrenia patient population
  • Demonstrated proficiency with medical terminology
  • Demonstrated proficiency with EEG
  • Ability to abstract data from medical records and transfer it to data collection forms or directly into databases
  • 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

Responsibilities

  • Patient Management: Working in collaboration with others, schedules, leads, and tracks patient visits, tests, procedures and follow up according to protocol; provides calendars and schedules to patients; 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.
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