Clinical Research Coordinator
Job Summary The shifts will regularly extend to evening and overnight hours with an average of three weekend shifts per month.
This position supports a research program aimed at improving outcomes for of injured patients. This program enrolls human subjects who are hospitalized and receiving care at the University-affiliated Level 1 trauma center, Zuckerberg San Francisco General (ZSFG) and there is an affiliated wet-lab focused on understanding the biologic mechanisms of platelet function after injury.
The purpose of this clinical research coordinator (CRC) position is to carry out the needed tasks to support several ongoing and future clinical trials and translational research studies relating to critically-ill and injured patients at ZSFG.
This CRC position will screen and enroll subjects in interventional trials and observational cohort studies, perform data entry, and process biological specimens. CRC will obtain biospecimens, including serial samples of blood, urine, and tracheal aspirates with the assistance of nurses, respiratory therapists, physicians providing clinical care to enrolled study subjects. The CRC will label, process, and log these specimens according to study protocols. This work must be done on site at the hospital and trauma center and remote work is not an option for executing the job duties described below. Notably, all job duties may include direct interactions with patients with active SARS-CoV-2 infection. CRCs will wear appropriate personal protective equipment and are required to meet the University and Hospital requirements for COVID-19 vaccine status as well as infection control screening and testing guidelines. In addition, there are required night and weekend shifts standard in the schedule, which is shared with other CRCs with the same job description. There is not an opportunity to obtain a work visa as part of this position.
The primary focus of this work is to enroll patients in studies shortly after injury and critical illness and to follow them and collect data and biological specimens longitudinally during their hospital stay. The incumbent's effort will be dedicated to clinical and translational research projects run by physician scientists who are Critical Care providers with appointments in the Departments of Surgery. This work focuses on enrolling hospitalized patients with severe traumatic injuries, critical illness, or COVID-19 infection.
Under the supervision of the site principal investigators, the CRC will screen patients in the emergency department, and medical and surgical intensive care units for eligibility for randomized controls trials (RCTs) and work closely with study physicians to coordinate communications with pharmacy and blood bank staff members as well as patients and surrogates in efforts to obtain consent.
The CRC will implement the protocols that initiate preparation and administration of study drugs/blood products and monitor subjects in the hours and days after administration. The study investigators and clinical nursing staff will perform all safety checks and technical aspects of drug administration as these tasks are within their clinical scope of practice and the CRC will be responsible for facilitating transmission of documents, working with the investigator to ensure all documentation and checklists are completed as outlined in the standard operating procedures of each study.
As part of their responsibilities, the CRC will screen patients in the Emergency Department and Intensive Care Units for longitudinal cohort studies of patients with either risk of organ injury, with active SARS-Co-V2 infection, or severe traumatic injuries. These studies build large clinical data bases and biorepositories that support several independent lines of investigation. The incumbent will work closely with a group of CRCs that respond to all major trauma calls, and will screen all trauma patients according to several study protocols.
The CRC will obtain biospecimens, including serial samples of blood, urine, and tracheal aspirates with the assistance of nurses, respiratory therapists, physicians providing clinical care to enrolled study subjects. The CRC will label, process, and log these specimens according to study protocols.
The collection, processing, and storage of biospecimens will require mastery of basic laboratory techniques including but not limited to centrifugation and pipetting while following proper precautions for safe handling human biospecimens and disposal of reagents. The steps needed to complete this task include but are not limited to transferring whole blood collected by bedside clinicians to 1) centrifuge tubes using a pipet, spinning the tubes in a centrifuge and aliquoting, labeling and storing plasma and cell pellets or 2) assay wells/plates/tubes and adding standardized reagents for functional testing of clotting on specialized bench top laboratory equipment. The processing of biospecimens is anticipated to take 1 to 3 hours per sample depending on the type of processing required, and can be required during every shift depending on what patients are hospitalized. Training and support in proper equipment calibration and use will be provided.
The CRC will perform extensive medical record review on each enrolled subject and data entry for annotation of data fields in a HIPPA compliant web-based platform.
For the interventional and observational studies, the CRC duties may include, but will not be limited to supporting the management and coordinating the tasks of multiple clinical research studies, oversee data and biospecimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; help manage Investigator's protocols in the Committee on Human Research online system, 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; report study progress to investigators; participate in any internal and external audits or reviews of study protocols.
To accomplish these goals, the CRC will work closely with the physician scientists, key study personnel and collaborating investigators, and other CRCs in the trauma and critical care research group. The CRC will strictly follow the study protocols; participate in meetings, teleconferences and site visits; maintain study logs, forms and files, and enter research data into databases. The CRC may be asked to sign non-disclosure agreements with industry partners. 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. The salary range for this position is $34.32 - $55.19 (Hourly Rate). To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html Department Description The UCSF Department of Surgery at Zuckerberg San Francisco General provides surgical services for the benefit of our patients and professional colleagues twenty-four hours each day, seven days a week. Our Trauma Center excels in the care of patients with injuries, burns, complex wounds, surgical infections and patients requiring surgical critical care. UCSF surgeons at Zuckerberg San Francisco General provide thoughtful consultation to our referring colleagues and state-of-the-art surgical care to our patients. The physicians in this group are all faculty members at the University of California, San Francisco and work through an affiliation with Community Health Network and value our close cooperation in the pursuit of excellence. The research efforts of this group include optimizing resuscitation of patients with shock after injury, preventing and mitigating organ failures after injury, and public health interventions to support trauma prevention and trauma recovery.
Dr. Lucy Kornblith's research group is dedicated to improving outcomes for critically injured trauma patients through basic and translational science (https://kornblithlab.ucsf.edu). Dr. Kornblith is a surgeon scientist and an expert in coagulopathy, platelet biology, functional laboratory measures of coagulation, and in nuances of biospecimen collection in large cohorts of severely injured patients. Her expertise in these domains facilitated leadership of international COVID-19 related platform trials targeting the hypercoaguable state observed in patients with severe complications of SARS-CoV-2 infection. Required Qualifications
- 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 Qualifications
- BA/BS degree in a related field
- Spanish or Cantonese language proficiency
- Previous experience/exposure to the prehospital environment, an emergency department, or an intensive care unit as a researcher, staff member, or volunteer
- Knowledge or experience with the basic laboratory techniques or methods required by the position (safe handling practices, preparing and labeling samples and reagents for studies, proper use, storage and disposal of reagents)
- Ability to work daytime as well as regular evenings/nights and weekend shifts, and some holiday coverage as the needed
- Ability to work up to 10-hour shifts
- Must be able to sit or stand for long periods of time.
- Able to adhere to specific protocols for all data collection
- Demonstrate positive interpersonal skills, especially when interacting with other medical professionals including nurses, respiratory therapists, physicians, and paramedics.
- Excellent verbal and written communications and presentation skills
- Demonstrate problem solving abilities
- Exceptional attention to detail
- Superb organizational skills, punctuality and record of reliability
- Ability to multi-task and task-switch in a fast-paced environment while working with a diverse subject population
- Demonstrated computer proficiency with knowledge and experience with word processing, spreadsheet and presentation software, such as Microsoft Excel, Word and PowerPoint
- Willingness to comply with University and Hospital employee vaccination and testing requirements and adhere to personal protective equipment guidelines from Infection Control and Occupational Health. These guidelines may be dynamic, and the candidate must be willing to interact with patients who have active and transmissible infections including but not limited to SARS-Co-V2 and influenza virus infections.
- Willingness to work with patients and families experiencing acute illness and trauma.
- Medical terminology and clinical exposure preferred
- Experience with electronic medical records.
- Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
- Experience in entering clinical data into electronic databases with a high degree of accuracy.
- Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.
- Experience building and maintaining databases in REDCap
- Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
- 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
- Experience working with populations with diverse language preferences and social determinants of health.
- Experience working with professional interpreter services.
- Experience with community outreach, conducting surveys and study subject interviews
- Knowledge of research policies and guidelines, guidelines for transporting, processing, and storing human biospecimens, database building/analysis, and data management within some of the following: Access, Stata, R, and SASS/ SPSS.
- 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 at diversity.ucsf.edu
Join us to find a rewarding career contributing to improving healthcare worldwide. Equal Employment Opportunity The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Job Code and Payroll Title 009335 CLIN RSCH CRD Job Category Research and Scientific Bargaining Unit University Professional Technical Employees - Research Support Professionals Unit (UPTE-RX) Location Zuckerberg San Francisco General (ZSFG) Additional Shift Details TBD Variable Work Schedule |
University of California - San Francisco Campus and Health
remote work
Oct 05, 2024