Assistant CRC

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.

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available here.

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

Salary Information

The final salary and offer components are subject to additional approvals based on UC policy.

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

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:

• N/A

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).

%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

60%

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.
• Upon case confirmation and patient follow-up, REDCap access will be provided to check if the patient enrollment is eligible for payment
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Assist with Processing of purchase orders (through Bear Buy) of supplies, computers, office supplies, service agreements, and repair services.
• Help with tracking , receiving, distribution and storage of research supplies using site tracker
• Help with monitoring of expenditures

20%

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.

• Assist with obtaining informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.

• Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.

• 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

• Maintain source data collection forms for effective data collection, entry, and analysis.

10%

YES

Data Management:

10%

• 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%.)

%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

60%

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.
• Upon case confirmation and patient follow-up, REDCap access will be provided to check if the patient enrollment is eligible for payment
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Assist with Processing of purchase orders (through Bear Buy) of supplies, computers, office supplies, service agreements, and repair services.
• Help with tracking , receiving, distribution and storage of research supplies using site tracker
• Help with monitoring of expenditures

20%

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.

• Assist with obtaining informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.

• Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.

• 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

• Maintain source data collection forms for effective data collection, entry, and analysis.

10%

YES

Data Management:

10%

• 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%.)