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UCSF

Public health sciences university in San Francisco

Clinical Research Coordinator - Thoracic & Sarcoma Oncology

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeSan Francisco, CA, USA$40.14 - $64.55

About the Job

Requirements

  • A high school diploma or equivalent experience is required.
  • Experience in clinical research, or demonstrated knowledge of research or training experience that translates into a clinical research setting, is required; familiarity with specimen processing is needed.
  • Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting, is required.
  • Attention to detail and effective verbal and written communication skills to coordinate with subjects, team members, departments, and outside institutions are required.
  • The ability to multitask in a fast-paced environment while working with a diverse subject population is required.
  • The ability to work independently, complete projects in a timely manner, and prioritize multiple projects to meet deadlines is required.
  • Demonstrated knowledge and understanding of research, especially biological sciences, is required.
  • Prior experience with Microsoft Office, internet-based databases, and specialized software such as OnCore is required.
  • The role requires the ability to sit and work at a computer for several hours per day and to stand for several hours of the day; travel between one or more campuses via UCSF shuttle may be needed.
  • The ability to apply relevant information to the assessment, interpretation, and processing of medical data is required.
  • The ability to independently interpret and apply policies, respond to requests, resolve issues, and assist faculty and staff at all levels in a team-oriented environment is required.
  • The ability to work with an oncology patient population is required.

Responsibilities

  • Execute, manage, and coordinate research protocols independently or with general direction, as directed by the Clinical Research Manager or Principal Investigator; coordinate data collection and operations for concurrent studies under protocol, UCSF, and regulatory guidelines.
  • Support management and coordinate tasks for one or more clinical research studies according to their size and complexity.
  • Act as an intermediary between services and departments while overseeing data and specimen management; manage and report study results.
  • Create, clean, update, and manage databases, comprehensive datasets, and reports.
  • Coordinate staff work schedules, assist in training Assistant Clinical Research Coordinators and other team members, and assist the Research Personnel Manager or Principal Investigator with oversight of research staff.
  • Assure compliance with relevant regulatory agencies, oversee study data integrity, and implement and maintain periodic quality-control procedures.
  • Interface with departments to obtain UCSF approval before study initiation and maintain regulatory documents with the Regulatory department.
  • Report study progress to investigators and participate in internal and external audits or reviews of study protocols.
  • Work with the Principal Investigator, Clinical Research Manager, and research team to identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
  • Prepare protocols for initiation in accordance with federal, state, and local research regulations and guidelines and cancer-center clinical practice methods.
  • Schedule study visits; administer questionnaires, collect medical histories, and perform study procedures.
  • Maintain rapport and effective communication with subjects, respond to their needs, schedule follow-up appointments, and act as their intermediary; discuss study outcomes with providers to support continuity of care.
  • Review information with subjects and assess and advocate for patient safety throughout protocol procedures.
  • Oversee subject billing and reimbursements and resolve discrepancies and issues in a timely manner.
  • Coordinate with study and clinic staff to ensure study procedures are completed; communicate and coordinate with other studies, technicians, and affiliated groups to support scheduling efficiency and patient safety.
  • Recommend enhancements to patient coordination, data collection, data management, protocol adherence, and study collaboration; suggest study-process modifications to improve efficiency.
  • Under the supervision of the Principal Investigator, study investigators, and Clinical Research Manager, educate clinical staff about protocol information relevant to safe clinical care, and relay study-drug and study information to clinical staff and patients.
  • Review medical charts and electronic records to extract medical information and study data; collect visit data and enter information from visits, procedures, laboratory tests, and other participation into databases promptly.
  • Collect, report, and manage follow-up patient data; manage and update each protocol's database structure and create databases as needed to improve data analysis and management.
  • Create and maintain study source documentation, blood and tissue sample tracking, and other protocol activity records to ensure compliance; maintain comprehensive datasets and data-collection forms.
  • Respond to database queries and analysis requests; maintain complete and accurate study and internal databases, including OnCore, and analyze data as it becomes available.
  • Use data collection and reporting instruments and databases, including OnCore, iMEDris, and Apex EMR; maintain applicable subject-tracking systems.
  • Oversee data integrity and assess the adequacy of policies and procedures for subject recruitment, data collection, and data management.
  • Maintain a procedure manual for study-related procedures and ensure consistency in data collection and entry.
  • Process, store, and ship specimens in accordance with laboratory policies and safety measures; arrange specimen exchanges and transport with collaborating investigators and staff.
  • Ensure sample-derived data is correctly entered into databases and reviewed by the Investigator; maintain the integrity and security of samples.
  • Conduct studies according to the Code of Federal Regulations, Good Clinical Practice, and UCSF regulations; initiate and follow up on iMEDris submissions for single-patient exceptions, adverse-event reporting, and protocol violations.
  • Maintain regulatory documents, monitor data-submission timelines, document adverse events, and submit them to appropriate departments.
  • Maintain patient confidentiality when communicating with agencies, healthcare providers, studies, and outside departments; cooperate with internal and external audits and prepare necessary documentation.
  • Assist the Supervisor in training staff, peers, and others on new protocols, procedural changes, data collection and entry, database procedures, medical-chart review and storage, and related procedures.
  • Attend and participate in regular team meetings and professional development opportunities; support staff-wide assignments such as filing, cleaning and maintaining study supplies, maintaining shared office and laboratory spaces, and developing policies and procedures.

Desired Qualifications

  • Knowledge of and experience managing oncology clinical trials.
  • Analytical and writing skills in a science or research environment.
  • Fluency in the Committee of Human Research online iMEDris system for protocol submission, renewal, and modification.
  • Understanding of the patient population to build rapport and assess what is realistic and appropriate for patient participation.
  • Experience with electronic medical records.
  • Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality, and HIPAA; the UCSF research mission; patient safety and confidentiality procedures for electronic and paper medical records, patient charts, and communication; medical terminology; research policies and guidelines; procedures for packing and shipping infectious substances; and database building, analysis, and data management using Access, Stata, SAS, SPSS, or Teleform programming platforms.
  • Membership in a clinical research professional society.
  • Experience applying Good Clinical Practice Guidelines, the Health Insurance Portability and Accountability Act, protections for human research subjects, Committee of Human Research regulations for recruitment and consent, effective cash-handling procedures, Environmental Health and Safety training, and fire safety training.

About the Company

UCSF

Public health sciences university in San Francisco

UC San Francisco is a public research university in San Francisco focused solely on health sciences, combining professional education with biomedical research and patient care. Its schools of dentistry, medicine, nursing and pharmacy train clinicians and scientists, while teams investigate cancer, immunology, genomics and neuroscience. UCSF Medical Center and Benioff Children's Hospitals connect clinical care with faculty research and training, and university clinics serve patients across Northern California. Founded in 1864, UCSF is the University of California campus dedicated to graduate and professional education and biomedical research, based in San Francisco.

Company size
10,001+
Company stage
Not listed
Total funding
Not listed
Headquarters
Not listed
Founded
1864

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