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The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI); coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF, and regulating agency policies. The incumbent's duties may include, but will not be limited to the coordination of activities in research studies focused on sleep disruption in healthy aging and neurodegenerative diseases. They will act as intermediary between services and departments while overseeing data and specimen management; will utilize electrophysiological sleep equipment and electroencephalography collection; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules and assist with training of Assistant CRCs; manage Investigator's protocols in the Committee on Human Research and Western Institution Board online systems, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators and attend team meetings; prepare at-home movement and sleep measuring devices; administer and analyze sleep and circadian recording; administer cognitive tests; and perform other duties as assigned. A proportion of this position will take place off-site, typically in a hotel setting, and will require having reliable transportation to various locations throughout the Bay Area. It will require flexible evening hours and may also require flexible daytime hours.
% of time (Nothing less than 5%) |
Essential Function (Yes/No) |
Key Responsibilities (To be completed by Supervisor) |
| 30% |
YES |
Study Coordination and Patient Management
- Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
- Schedule subjects for study visits; meet with them to administer questionnaires, train them on sleep equipment, collect medical history, and perform other 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; discuss study outcomes with providers to ensure continuity of care.
- Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
- Oversee subject reimbursement; work to resolve discrepancies and issues.
- Work with staff to ensure procedures are completed; required data collected at visits; and ensure correct shipping and labeling measures.
- Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
- Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
- Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
|
30% |
YES |
Data and Equipment Management
- Collect data during subject visits; enter data from visits, procedures, 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 PI.
- Maintain data collection forms for effective data collection, entry, and analysis.
- Perform queries and analysis in databases.
- Maintain complete and accurate data in the study database; analyze the data as they become available.
- Ensure electrode and sensor recording integrity by troubleshooting common recognizable defects/malfunctions.
- Manage the maintenance of the polysomnography equipment and at-home sleep/circadian and cognitive testing supplies.
- Check proper functioning of electrophysiological and testing equipment.
|
5% |
YES |
Staff training
- Assist with the training of staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, at-home sleep devices including actigraphy, apnealink, mobile EEG measures, and movement sensors.
- Attend and actively participate in regular team meetings.
- Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
- Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
- Implement and maintain periodic quality control procedures.
- Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.
- Modify data collection instruments.
- Help schedule staff time and coordinate staff schedules.
- Administer sleep assessments and neuropsychological assessments.
- Maintain subject tracking systems.
|
5% |
YES |
Quality control procedures |
10% |
YES |
Study Implementation |
10% |
YES |
Protocol Submissions and Adherence
- Enter all existing and new study protocols into the Committee on Human Research (CHR) online system and/or the Western Institutional Review Board system; seek assistance on maintaining all protocols in the system by communicating with UCSF Analysts.
- Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality.
- Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance.
- Renew, modify, and submit applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between IRB and study Investigators.
- Provide quality assurance checks to note if protocols or applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.
|
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.
- Interface with departments to obtain UCSF approval prior to study initiation.
- Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.
- Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
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100% |
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(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%.) |
Required Requirements * HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training. * 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. Preferred Requirements * AS or BS degree in related field * Experience working with patients or study subjects, preferably with individuals with neurodegenerative diseases. * Experience coordinating remote studies, clinical trials, and data collection. * Experience administering cognitive and neuropsychological assessments, and working with polysomnography sleep assessments and at-home sleep monitoring devices. * 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 substances, database building/analysis, and data management. * Prior experience or able to demonstrate ability to be trained to administer Multiple Sleep Latency Tests and/or Maintenance of Wakefulness Tests, process and score polysomnography sleep measures, ideally from both healthy and neurodegenerative populations. * Experience working with Ambulatory Monitoring Actigraphy devices, Philips Actiwatch Spectrum Plus, ApneaLink assessments for sleep apnea, Zeo for mobile sleep monitoring and/or Advanced Brain Monitoring Sleep Profiler. * Experience coding in Matlab, R and python. * Experience with EEG signal processing. * 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
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 Requirements * HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training. * 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. Preferred Requirements * AS or BS degree in related field * Experience working with patients or study subjects, preferably with individuals with neurodegenerative diseases. * Experience coordinating remote studies, clinical trials, and data collection. * Experience administering cognitive and neuropsychological assessments, and working with polysomnography sleep assessments and at-home sleep monitoring devices. * 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 substances, database building/analysis, and data management. * Prior experience or able to demonstrate ability to be trained to administer Multiple Sleep Latency Tests and/or Maintenance of Wakefulness Tests, process and score polysomnography sleep measures, ideally from both healthy and neurodegenerative populations. * Experience working with Ambulatory Monitoring Actigraphy devices, Philips Actiwatch Spectrum Plus, ApneaLink assessments for sleep apnea, Zeo for mobile sleep monitoring and/or Advanced Brain Monitoring Sleep Profiler. * Experience coding in Matlab, R and python. * Experience with EEG signal processing. * 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
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