Clinical Research Coordinator

This position requires the candidate to have a high degree of proficiency in Mandarin, Cantonese or both languages (oral, comprehension, writing and reading) in order to perform the following tasks: Entry-level duties related to the support and coordination of clinical studies of participants with language difficulties enrolled within the UCSF Memory and Aging Center specifically within the Tee Lab.

• Coordination of one or more single or multi-site, active or follow-up trials
• Help prepare protocols for study initiation, design flow sheets, data forms and source documents, help recruit, enroll, register, schedule and retain study subjects
• Apply understanding of inclusion/exclusion eligibility criteria for protocols, 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
• Data: collect, enter and clean, maintain quality, assist w analysis and preparation of reports and tables

Responsibilities

of time

Essential Function (Yes/No )

Key Responsibilities

(To be completed by Supervisor)

30

YES

Study Coordination and Data Collection (Essential)

• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• Schedule subjects for study visits; send confirmations and paperwork before research visit; meet with them to administer questionnaires, collect medical history and perform study procedures.
• Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; communicate to health care provider research findings through a report prepared by the attending physician.
• Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure. Translates English documents such as surveys or consents into Chinese (Mandarin) as well as translating spoken English for our monolingual Chinese participants.
• Assist with the administration of neuropsychological assessments by translating English documents such as surveys or consents into Chinese (Mandarin) as well as translating spoken English for our monolingual Chinese participants and collect data in a standardized manner.
• Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.

30

YES

Data Management and reporting of results

• Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
• Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
• Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Perform queries and analysis in databases.
• Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.

10

YES

Regulatory responsibilities

• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations
• Initiate and follow-up on IRB submissions and modifications; track approval status.
• Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation

10

YES

Outreach activities

• Assist PI and Clinical Research & Community Outreach Coordinator in the development of educational material (flyers, handouts, presentations).
• Develop recruitment and retention strategies, and coordinate community outreach events.
• Compose PowerPoint presentations or prepare outreach materials (gifts and prizes)
• Identify subjects, develop recruitment and retention strategies, screen and enroll study subjects.
• Create and maintain recruitment databases for multiple studies.
• Query and analyze recruitment metrics for weekly updates, identify recruitment challenges and develop strategies to overcome them.
• Develop and maintain website for study projects and research lab, create education and research materials.

15
Yes
Quality control procedures

• Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
• Arrange the exchange of and transport of specimens with collaborating Investigators and staff. Ensure integrity and security of samples.

5
Yes
Protocol Submissions and Adherence

• Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts.
• Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance.
• Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators.
• Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed including accurate translation for study forms into Chinese.

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%.)

Qualifications

Required Qualifications

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities or equivalent combination of experience/training
• Native language abilities in Cantonese and/or Mandarin (expressive and receptive language as well as reading and writing) and English. This position will specifically reach out to Asian population in the Bay Area; therefore, a bilingual and bicultural candidate is required.
• 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 establish cooperative working relationships with patients, co-workers, & physicians.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Excellent analytical and problem-solving skills.
• Ability to establish cooperative working relationships with patients, co-workers, & physicians

Preferred Qualifications

• 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.
• Preparation of reports and PowerPoints and compilation of data for presentation at meetings
• 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: Access, Stata, SASS/ SPSS, and Teleform programming platforms
• Bachelor's Degree in relevant fields, and one or more years of recent, directly related work experience following degree completion, utilizing the techniques or methods required by the position; or an equivalent combination of education and experience.
• Experience in REDCap, Qualtrics, or other research software for data management; and experience in data management and data entry
• Experience working with patients or study subjects.
• Experience performing community outreach with Asian population.
• Bilingual (Mandarin-English) Medical Interpreter Certification.
• Knowledge or experience with basic clinical research techniques and methods, such as subject screening, consenting, and privacy practices (including CITI or similar certification); and knowledge of IRB procedures including study applications, renewals, and modifications
• 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