Clinical Research Coordinator

University of California San Francisco•San Francisco, CA

16d•$34 - $55

About The Position

The Clinical Research Coordinator will manage and coordinate several clinical studies in the Department of Ophthalmology, working with one or more faculty members, depending on the trial or project. The clinical studies supported by this position take place primarily located at Zuckerberg San Francisco General Hospital, where the position is based, and occasionally at other UCSF campuses. 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) for the study/trial; may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. 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, depending on their size and complexity; interview patients and obtain consent for participation in research studies; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, and assist principal investigator with oversight of other research staff; 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; participate in any internal and external audits or reviews of study protocols; collect biospecimens such as patient blood samples; obtain basic non-invasive eye scans for research studies; and perform other duties as assigned. This position is responsible for managing clinical studies including: independently drafting institutional research board submissions, modifications and communications, data management, patient follow-up, and regulatory tasks. Additionally, this position is responsible for compliance auditing and regulatory documentation. Reporting to the Principal Investigator, the candidate has central responsibility for ensuring CHR approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts. The main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities. The candidate will assume primary responsibility for communications with the institutional review board on behalf of the supervising physicians. The candidate will interface with other research staff, post-doctoral fellows, and medical students. The candidate will manage clinical trials including: consenting and enrolling subjects; administering questionnaires; ensuring laboratory work and required tests are carried out on time and appropriately; discussing informed consent forms with patients directly; shipping and handling of specimens sent to collaborating research laboratories; communicating with local, national, and international research laboratories; and managing the research data. 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

Requirements

HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
Attention to detail
strong interpersonal skills
excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions
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
Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Windows
Database experience
Excellent analytical and problem-solving skills
Ability to establish cooperative working relationships with patients, co-workers, & physicians
Demonstrated ability to develop patient recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals
Project management skills to oversee the administrative operations of the clinical trials program
knowledge of strategies for recruiting human subjects
Exceptional analytical skills to evaluate the importance and urgency of problems
excellent demonstrated interpersonal, verbal and written communication skills
Ability to analyze complex and non-routine issues requiring innovative solutions
Ability to operate effectively in a changing organizational and technological environment
Ability to assess and respond to audit risk
ability to develop project plans/schedules and motivate team to meet deadlines
Ability to interpret and apply policies and regulations
Fluency in spreadsheet software
ability to develop complex spreadsheets independently
demonstrated skills in audit preparation, execution, and follow-up
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
Experience with electronic medical records
Ability to handle bio-specimens including experience with their processing, storage, and shipment
Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA 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
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 Equal Employment Opportunity

Nice To Haves

Ability to obtain and maintain an active phlebotomy license
Ability to perform technician ophthalmic skills including, but not limited, to noninvasive imaging, visual tests, refraction, and tonometry

Responsibilities

supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity
interview patients and obtain consent for participation in research studies
act as intermediary between services and departments while overseeing data and specimen management
manage and report on study results
create, clean, update, and manage databases and comprehensive datasets and reports
coordinate staff work schedules, and assist principal investigator with oversight of other research staff
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
participate in any internal and external audits or reviews of study protocols
collect biospecimens such as patient blood samples
obtain basic non-invasive eye scans for research studies
independently drafting institutional research board submissions, modifications and communications
data management
patient follow-up
regulatory tasks
compliance auditing and regulatory documentation
communications with the institutional review board on behalf of the supervising physicians
consenting and enrolling subjects
administering questionnaires
ensuring laboratory work and required tests are carried out on time and appropriately
discussing informed consent forms with patients directly
shipping and handling of specimens sent to collaborating research laboratories
communicating with local, national, and international research laboratories
managing the research data