Clinical Research Coordinator - Neurological Surgery

UCSF Health, AG; Oakland (CA); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

The University of California San Francisco is seeking a Clinical Research Coordinator (CRC) to join the Traumatic Brain Injury (TBI) research team within BASIC at ZSFG Hospital. The CRC will coordinate studies, manage data, and liaise with neurosurgery, neurology, pharmacy and radiology to ensure protocol integrity and regulatory compliance.

Responsibilities include subject screening/enrollment, visit scheduling, data collection, and overseeing data quality, with opportunities to train and

Qualifikationen

• High School Diploma or equivalent experience
• Experience with patient reported outcomes and standardized assessments
• Experience with data abstraction and data entry
• Proficient in Word, Excel, Access, PowerPoint
• Strong verbal and written communication across diverse groups
• Ability to multitask in a fast-paced environment
• Strong organizational and analytical skills
• Ability to work independently and meet deadlines
• Team-oriented with collaboration across departments
• Familiarity with policies on reimbursement, privacy and safety regulations

Aufgaben

• Coordinate and manage multiple clinical research studies per protocols
• Screen and enroll study subjects and schedule visits
• Administer questionnaires and collect medical histories
• Maintain regulatory documents and databases
• Alliase with departments (neurosurgery, neurology, radiology) for data and logistics
• Assist training and oversight of other research staff
• Ensure compliance with regulatory agencies and audits
• Support data integrity and reporting to investigators

Kenntnisse

Communication

Data entry

Microsoft Office

Multitasking

Team collaboration

Independent work

Ausbildung

BA/BS in related field

Experience in clinical research

Tools

Electronic Medical Records

CHR IRB-iRIS

SQL/SPSS/Stata

Jobbeschreibung

Description & RequirementsJob Description

The University of California San Francisco is seeking applications for the Clinical Research Coordinator (CRC) to join the Traumatic Brain Injury (TBI) research team. Within the Department of Neurological Surgery, the Brain and Spinal Injury Center (BASIC) is a large clinical and research division with over 40 physicians, nurses, research faculty, staff and trainees at the ZSFG Hospital campus. Many colleagues from other departments, other universities throughout the US, and other countries form an active group of investigators and staff with whom we collaborate. The incumbent will serve as a member of the BASIC TBI clinical research team.

The CRC 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 Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

The CRC duties may include, but will not be limited to, supporting the management and coordinating the tasks of single or multiple clinical research studies, both industry and federally funded. Duties may include screening and enrolling study subjects, scheduling subjects for study visits, administering questionnaires, collecting medical history and performing study procedures. Coordination of studies will require the CRC to act as intermediary between services and departments (e.g., neurosurgery, neurology, pharmacy, radiology) while overseeing data and specimen management; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, and assist the Research Supervisor at BASIC and/or PI with training and oversight of other research staff; manage Investigator's protocols in the Committee on Human Research online system; help assure compliance with all relevant regulatory agencies; oversee study data integrity; 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; and perform other duties as assigned.

QualificationsRequired Qualifications

• High School Diploma; and/or equivalent experience/training
• Experience with administering patient reported outcome measures and standardized assessments
• Experience with data abstraction and data entry
• Excellent computer skills and demonstrated proficiency working with Microsoft Word, Excel, Access, and PowerPoint
• 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
• Excellent analytic and organizational skills, and an ability to operate independently, prioritize, and create detailed timelines and schedules for several different tasks, managing each task from beginning to completion
• Advanced interpersonal skills, judgment, and diplomacy when communicating with staff and faculty at different levels of an organization; ability to work with diverse groups including physicians, researchers, faculty, fellows, students, nurses, and support staff. A proven ability to interact and effectively influence within a dynamic organization
• Proven ability to be self-motivated and perform effectively under the pressure of deadlines and multiple competing projects.
• Ability to independently interpret and apply policies, respond to requests, resolve issues, and provide assistance to faculty and staff at all levels in a team-oriented environment
• Must be a team-player, participating in assignments and taking on tasks of coworkers as needed by the group, which includes participating in weekly team meetings, juggling competing priorities of individually assigned studies and those of the research team as a whole, and communication/development of best clinical practice procedures within the team

Preferred Qualifications

• BA/BS with a major in a related field, including two years of experience in clinical research
• experience with coordination of neurological/neurosurgical human subjects research studies
• Experience with electronic medical records
• 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 medical terminology, and the ability to apply it to the assessment, interpretation, and processing of medical data
• Excellent analytic and organizational skills, and an ability to operate independently, prioritize, and create detailed timelines and schedules for several different tasks, managing each task from beginning to completion
• 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 SQL
• Fluency in the usage of Committee of Human Research (CHR) IRB-iRIS (formerly iMedRIS) for submission, renewal, and modification of protocols through this system
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• 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