Assistant Clinical Research Coordinator Neuro Spine

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; make PowerPoints; assist writing abstracts and manuscripts; coordinate meeting travel and budgets; and perform other duties as assigned.

Key Responsibilities

• 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. Assist the Senior Clinical Research Coordinator and the Principal Investigator in selecting study patients by reviewing inclusion/exclusion study criteria.

• 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. Collect clinical data during clinics and/or over the phone. Select the appropriate clinical forms according to patient’s diagnosis (cervical vs lumbar vs deformity). The clinical data that is being collected is patient reported outcomes based on a detailed questionnaire provided by the faculty/doctor. They are asking questions from this questionnaire and gathering the answers from the patient. Enter data into our database; submit required data with accuracy and timeliness.

• 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. Help maintaining clinical data organized and perform other 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.
• Experience in data science- machine learning or artificial intelligence.
• Training/experience in the conduct of clinical research trials in an academic research environment.
• Familiarity with UCSF processes and systems; experience and knowledge of CHR/IRB policy and procedure.
• Attention to detail