Clinical Research Coordinator - Head and Neck Oncology

UCSF•San Francisco, CA

5d•$40 - $65

About The Position

The Clinical Research Coordinator works independently or with general direction at the fully operational journey level to execute, manage, and coordinate clinical research protocols, as directed by the Clinical Research Manager and Principal Investigator. The role may coordinate data collection and operations for several concurrent studies, depending on their size and complexity, while following research protocols and UCSF and regulatory agency policies. The coordinator supports study management and coordination, acts as an intermediary among services and departments, oversees data and specimen management, manages and reports study results, and creates and maintains databases, datasets, and reports. The role also supports staff scheduling and training, helps oversee research staff, maintains regulatory documentation, ensures compliance and data integrity, conducts quality-control procedures, obtains UCSF approvals before study initiation, reports progress to investigators, and participates in audits and protocol reviews. The position is in the UCSF Helen Diller Family Comprehensive Cancer Center, which integrates laboratory, clinical, patient-care, and population research focused on cancer. The coordinator supports head and neck oncology research and works with study participants, including oncology patients.

Requirements

High school graduation or equivalent experience.
Experience in clinical research, or demonstrated research knowledge or training that translates to a clinical research setting.
Familiarity with specimen processing.
Experience with Microsoft Office, internet-based databases, and specialized software such as OnCore.
Attention to detail; strong interpersonal skills; and effective verbal and written communication skills for coordinating with subjects, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment while working with a diverse subject population.
Ability to work independently, complete projects on time, and prioritize multiple projects to meet deadlines.
Demonstrated knowledge and understanding of research, especially biological sciences.
Ability to sit and work at a computer for several hours per day and stand for several hours per day; may need to travel between campuses via UCSF shuttle.
Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting.
Ability to apply relevant information to the assessment, interpretation, and processing of medical data.
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.
Ability to work with oncology patients, a sensitive patient population.

Nice To Haves

Prior analytical and writing skills in a science or research environment.
Fluency with the Committee of Human Research (CHR) online iMEDris system for protocol submissions, renewals, and modifications.
Understanding of the patient population and ability to build rapport while assessing realistic and appropriate patient participation.
Experience with electronic medical records.
Knowledge of UCSF and departmental policies for reimbursement, research, confidentiality, and HIPAA; the UCSF mission and research purpose; patient safety and confidentiality procedures; medical terminology; research policies and guidelines; and requirements for packing and shipping infectious substances.
Database-building, analysis, and data-management knowledge using tools such as Access, Stata, SAS, SPSS, or Teleform.
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, HIPAA, protections for human research subjects, CHR recruitment and consent regulations, Effective Cash Handling Procedures, Environmental Health and Safety Training, and Fire Safety Training.

Responsibilities

Work with the Principal Investigator, Clinical Research Manager, and research team to identify, screen, recruit, enroll, and retain study subjects.
Prepare protocols for study initiation, applying relevant research regulations, guidelines, and cancer center clinical practice methods.
Schedule study visits; administer questionnaires; collect medical histories; and perform study procedures.
Maintain communication and rapport with subjects, address their needs, arrange follow-up, act as an intermediary, and support continuity of care by discussing study outcomes with providers.
Review study information with subjects and advocate for patient safety throughout protocol procedures.
Oversee subject billing and reimbursements and resolve discrepancies.
Coordinate with study and clinic staff, other studies, technicians, and affiliated groups to complete procedures, schedule efficiently, and support patient safety.
Assess and recommend improvements to patient coordination, data collection and management, protocol adherence, and study collaboration; suggest process changes to improve efficiency.
Help educate clinical staff about protocol-specific care, study drugs, and study information for patients, under the supervision of the PI, investigators, and Clinical Research Manager.
Review medical charts and electronic records and extract information for studies.
Collect and enter data from visits, procedures, laboratory tests, and other study participation; manage follow-up data and respond to database queries in a timely manner.
Manage protocol databases, improve existing databases, create new databases as needed, and maintain subject-tracking systems.
Create and maintain source documentation, sample tracking, data collection forms, comprehensive datasets, procedure manuals, and records of protocol activities.
Maintain complete and accurate data in study databases and internal systems such as OnCore, and analyze data as it becomes available.
Use study data collection and reporting systems, including sponsored-study databases, OnCore, iMEDris, and Apex EMR.
Oversee data integrity and assess policies and procedures for recruitment, data collection, and data management; implement periodic quality-control procedures.
Ensure specimens are processed, stored, shipped, exchanged, and transported according to laboratory policies and safety measures; maintain specimen integrity and security.
Ensure data interpreted from samples is entered correctly into databases and reviewed by the Investigator.
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 and monitor submission timelines.
Document adverse events, submit them to appropriate departments, and protect patient confidentiality in communications.
Participate in internal and external audits and protocol reviews and prepare required documentation.
Assist with training staff and peers on protocols, procedures, data collection and entry, database procedures, chart review, and storage.
Attend and participate in team meetings and professional-development opportunities.
Participate in staff-wide assignments, including filing, maintaining study supplies and shared office and laboratory spaces, and developing policies and procedures.