U

UCSF

Public health sciences university in San Francisco

Clinical Research Coordinator - Genitourinary Oncology Program

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 required.
  • Experience with Microsoft Office, internet-based databases, and specialized software such as OnCore is required.
  • Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting, is required.
  • The role requires attention to detail, effective verbal and written communication, interpersonal skills to coordinate with subjects and internal and external teams, and the ability to multitask in a fast-paced environment with a diverse subject population.
  • The role requires the ability to work independently, complete projects on time, and prioritize multiple projects to meet deadlines.
  • Demonstrated knowledge and understanding of research, especially biological sciences, 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; it may require travel between UCSF campuses via shuttle.
  • The role requires the ability to apply relevant information to the assessment, interpretation, and processing of medical data.
  • The role requires the ability to interpret and apply policies independently, respond to requests, resolve issues, and assist faculty and staff at all levels in a team-oriented environment.
  • The role requires the ability to work with oncology patients, a sensitive patient population.

Responsibilities

  • Execute, manage, and coordinate research protocols under the direction of the Lead Clinical Research Coordinator, Principal Investigator, and/or Research Personnel Manager for the Investigational Trials Unit and Genitourinary Oncology Program.
  • Coordinate data collection and operations for concurrent clinical research studies according to research protocols and UCSF and regulatory agency policies.
  • Support management and coordination of one or multiple clinical research studies based on 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 with training Assistant Clinical Research Coordinators and other team members, and assist the Research Personnel Manager and/or Principal Investigator with oversight of other research staff.
  • Help ensure compliance with relevant regulatory agencies and oversee study data integrity.
  • Implement and maintain periodic quality-control procedures; obtain UCSF approval before study initiation; maintain regulatory documents in partnership with the Regulatory department; report study progress to investigators; and participate in internal and external audits or protocol reviews.
  • Work with the Principal Investigator, Lead Clinical Research Coordinator, and research team to identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
  • Prepare protocols for initiation, including ensuring working knowledge of applicable research regulations, guidelines, and cancer-center clinical practice methods.
  • Schedule study visits; administer questionnaires; collect medical histories; and perform study procedures.
  • Maintain rapport and communication with subjects, respond to their needs, schedule follow-up appointments, act as their intermediary, and discuss study outcomes with providers to support continuity of care.
  • Review study information with subjects and advocate for patient safety during protocol procedures.
  • Oversee subject billing and reimbursements and resolve discrepancies and issues promptly.
  • Coordinate with study and clinic staff to complete procedures, improve scheduling efficiency, and support patient safety with affiliated groups.
  • Assess and recommend improvements to patient coordination, data collection and management, protocol adherence, and study collaboration; suggest process modifications to improve efficiency.
  • Under the supervision of the Principal Investigator, study investigators, and Lead Clinical Research Coordinator, educate clinical staff about protocol information relevant to safe patient care and relay study-drug and study information to staff and patients.
  • Review medical charts and electronic records to extract study information; collect visit data and enter data from visits, procedures, lab tests, and other subject participation into databases on time.
  • Collect, report, and manage follow-up patient data; manage and update protocol databases, create new databases as needed, and create and maintain comprehensive datasets and data-collection forms.
  • Create and maintain source documentation and tracking for blood and tissue samples and other protocol activities; respond to database queries and analysis requests promptly.
  • Maintain accurate data in study and internal databases, including OnCore; analyze data as it becomes available; use data instruments and platforms including sponsored-study databases, OnCore, iMEDris, and Apex EMR; and maintain subject tracking systems.
  • Assess adequacy of policies and procedures for subject recruitment, data collection, and management; maintain procedure manuals and consistency in data collection and entry; and oversee data integrity.
  • Process, store, and ship specimens according to laboratory policies and safety measures; arrange specimen exchanges and transport with collaborating investigators and staff; verify sample data entry and investigator review; and ensure sample integrity and security.
  • Ensure studies comply with 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 submission timelines, document adverse events, and submit them to appropriate departments.
  • Protect patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments; cooperate with internal and external audits and prepare necessary documentation.
  • Assist the supervisor in training staff, peers, and others on protocols, procedure changes, data collection and entry, database procedures, medical-chart review and storage, and other procedures.
  • Attend and participate in regular team meetings and professional-development opportunities.
  • Participate in staff-wide assignments outside protocol management, including filing, cleaning and maintaining study supplies, maintaining office and laboratory common spaces, and developing policies and procedures.

Desired Qualifications

  • Prior analytical and writing skills in a science or research environment.
  • Fluency using the Committee of Human Research (CHR) online iMEDris system to submit, renew, and modify protocols.
  • Understanding of the patient population to build rapport and assess realistic and appropriate patient participation.
  • Experience with electronic medical records.
  • Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality and HIPAA regulations, the UCSF research mission, patient safety and confidentiality procedures for electronic and paper records, medical terminology, research policies and guidelines, infectious-substance packing and shipping, database building and analysis, and data management using Access, Stata, SAS/SPSS, and TeleForm platforms.
  • Knowledge of clinical research in breast oncology.
  • Knowledge and experience managing oncology clinical trials.
  • Membership in a clinical research professional society.
  • Experience applying Good Clinical Practice Guidelines, the Health Insurance Portability and Accountability Act (HIPAA), the Protection of Human Research Subjects, CHR recruitment and consent regulations, 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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