Clinical Research Coordinator

About the Role

The Clinical Research Coordinator will execute, manage, and coordinate research protocols under the direction of the Clinical Research Manager and Principal Investigator (PI). This role may involve coordinating data collection and operations for multiple concurrent clinical research studies, adhering to research protocols, and UCSF and regulating agency policies.

Key Responsibilities

• Support the management and coordination of single or multiple clinical research studies.
• 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.
• Coordinate staff work schedules, assist with training of Assistant CRCs and other CRC team members.
• Assist Research Personnel Manager and/or PI with oversight of other research staff.
• Ensure 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.
• Maintain 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.
• Experience in clinical research or demonstrated knowledge of research or training experience that translates into a clinical research setting.
• Familiarity with specimen processing.
• Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting.
• Attention to detail.
• Strong interpersonal skills.
• Excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments, and outside institutions.
• Ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Demonstrated knowledge and understanding of research, especially in the areas of biological sciences.
• Prior experience with various computer programs (Microsoft Office; internet-based databases).
• Experience using specialized software such as 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.
• Ability to apply relevant information to the assessment, interpretation, and processing of medical data.
• 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.
• Ability to work with a sensitive population of patients (oncology patients).

Qualifications (Preferred)

• Knowledge of clinical research in breast oncology.
• Knowledge and experience in managing oncology clinical trials.
• Prior analytical and writing skills in a science/research environment.
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols.
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Experience with electronic medical records.
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA 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.
• Knowledge of guidelines for packing/shipping infectious substances.
• Knowledge of database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
• Membership in a clinical research professional society.
• 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