The Assistant Clinical Research Coordinator will assist the PI with clinical research coordination of the following studies:

(1) a pediatric headache study sponsored by PCORI. UCSF is identified as an enrolling site. Under the PI and Clinical Research Manager; the incumbent may coordinate the data collection and operations of this trial (REACH) Responding with Evidence and Access for Childhood and Headaches under the guidelines of the Code of Federal Regulations, Good Clinical Practice, and UCSF policies.

(2) a pediatric headache study sponsored by Pfizer. Under the PI and Clinical Research Manager; the incumbent may coordinate the data collection and operations of this study Empowering Children and Adolescents Undergoing Needle-based Procedures for Headache Treatment through Implementation of a “Headache Procedure Comfort Menu”: a Novel Clinical Tool under the guidelines of the Code of Federal Regulations, Good Clinical Practice, and UCSF policies.

The incumbent’s duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies of varied size and complexity; help in research administration; assist with patient recruitment; help manage patient study source documents; perform data entry to study Case Report Form databases; collect, process and ship study specimens in accordance with study protocols; assist the PI with intermediary services and departments while overseeing data and specimen coordination; report study progress to the PI in regular team meetings; update spreadsheets tracking recruitment efforts; help coordinate subcontracts through collaborative effort with PI; assist with management of all Regulatory aspects of Investigator’s protocols in IRIS, the Committee on Human Research online system, including renewals and modifications of study protocols and the implementation of new studies; ensure study data integrity; assist with implementation of quality control procedures; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned as appropriate.

Required Qualifications:

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Excellent verbal and written communications and presentation skills ; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Proficiency with Microsoft Word, PowerPoint, and Windows.
• Excellent analytical and problem-solving skills.
• 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.
Proven trustworthiness with regards to confidential and highly sensitive information and documents

Required Licenses and/or Certifications:

Preferred Qualifications:

• Fluency in the usage of Committee of Human Research (CHR) online iIRISsystem 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.
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
• 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, Experience with electronic Clinical Research Form 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 and Fire Safety Training
• Experience in clinical trials. Experience with protocol compliance and patient safety for Investigational Medicinal Products (IMPs).
• Experience administering the Columbia Suicide Severity Rating scale (CSS-R).