Clinical Research Coordinator

About the Role

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Clinical Research Coordinator (CRC) to join the Cancer Immunotherapy Research & Clinical Translation (CIRCT) Program within the Division of Hematology/Oncology.

Key Responsibilities

• Independently execute, manage, and coordinate research protocols.
• Coordinate operations and data collection for concurrent clinical research studies under protocol, UCSF, and regulating agency guidelines.
• Support the management and coordination of single or multiple clinical research studies (sponsored, cooperative group, and investigator-initiated).
• Act as an intermediary between services and departments, overseeing data and specimen management.
• Manage and report on study results.
• Create, clean, update, and manage databases and comprehensive datasets and reports.
• Assist with training of Assistant CRCs.
• 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.
• Assist in maintaining relevant regulatory documents in partnership with the Regulatory department.
• Report study progress to investigators.
• Participate in internal and external audits or reviews of study protocols.
• Perform other duties as assigned.

Requirements & Tech Stack

• High School Diploma; or equivalent experience/training.
• Experience in clinical research or demonstrated research/training experience.
• Experience with medical charts and electronic records.
• Familiarity with specimen processing, or demonstrated ability to learn.
• Working knowledge of, or demonstrated ability to learn, federal, state, and local research regulations and guidelines, and research practice methods.
• Ability to interpret and apply policies, respond to requests, resolve issues, and provide assistance.
• Ability to work with a sensitive population of patients (oncology patients).
• Ability to work across several different programs, reporting to 2-3 different supervisors.
• Attention to detail.
• Strong interpersonal skills.
• Excellent, effective verbal and written communication skills.
• Ability to multi-task in a fast-paced environment.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects.
• Demonstrated knowledge and understanding of research, especially in biological sciences.
• Exceptional database management experience.
• Prior experience with various computer programs (Microsoft Office, internet-based databases) and specialized software (e.g., OnCore).
• Ability to sit and work at a computer for several hours per day.
• May need to travel between one or more campuses via UCSF shuttle.
• Ability to stand for several hours of the day.

Qualifications

• Bachelor's degree with a major in science or related (Preferred).
• Prior analytical and writing skills in a science/research environment (Preferred).
• Knowledge of clinical research in oncology (Preferred).
• Knowledge and experience in managing oncology clinical trials and experience with Phase I-III trials (Preferred).
• Membership in a clinical research professional society (Preferred).
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system (Preferred).
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation (Preferred).
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals (Preferred).
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA regulations, UCSF mission statement, patient safety, and confidentiality (Preferred).
• Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within platforms such as Access, Stata, SASS/ SPSS, and Teleform (Preferred).
• Experience applying the following regulations and guidelines:
• Good Clinical Practice Guidelines (Preferred)
• Health Information and Accountability Act (HIPAA) (Preferred)
• The Protection of Human Research Subjects (Preferred)
• CHR regulations for recruitment and consent of research subjects (Preferred)
• Effective Cash Handling Procedures (Preferred)
• Environmental Health and Safety Training (Preferred)
• Fire Safety Training (Preferred)