Clinical Research Coordinator

About the Role

The Clinical Research Coordinator (CRC) will execute, manage, and coordinate research protocols under general direction within the Department of Pediatrics at Benioff Children's Hospital in Oakland, CA. This position may support multiple investigators and divisions, with assignments potentially changing based on funding.

Key Responsibilities

• Coordinate the operations of concurrent clinical research studies under research protocols, UCSF, and regulating agency policies.
• Enroll patients in clinical studies.
• Perform data entry and management.
• Conduct biospecimen collection and processing.
• Attend and document proceedings at relevant meetings.
• Prepare grant proposals and reports.
• Complete regulatory documents, Institutional Review Board applications, revisions, and reports.
• Support the management and coordination of 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 and assist with oversight of other research staff.
• Manage Investigator’s protocols in the Committee on Human Research online system, including renewals and modifications of Institutional Review Board applications and implementation of new studies.
• Participate in the review and writing of protocols to ensure institutional review board approval within University compliance.
• Help 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 all regulatory documents.
• 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.
• Proficiency with Microsoft Word, PowerPoint, and Windows.
• Ability to establish cooperative working relationships with patients, co-workers, & physicians.

Qualifications

• Excellent verbal and written communications and presentation skills.
• Excellent organizational skills.
• Excellent interpersonal skills to work effectively in a diverse team.
• Attention to detail.
• Strong interpersonal skills.
• Excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments, and outside institutions and companies.
• Ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Excellent analytical and problem-solving skills.
• Ability to work well independently and complete projects in a timely manner.
• Ability to work in a fast-paced, team-based environment.
• Project management and coordination skills.
• Ability to prioritize tasks and meet multiple deadlines on concurrent projects.

Preferred Qualifications

• Demonstrate proficiency with medical terminology.
• Experience working with patients or study subjects.
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
• 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 UCSF guidelines for research, confidentiality and Health Information and Accountability Act (HIPAA) regulations, following the UCSF mission statement and purpose for research, and clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.).
• Experience applying the following regulations and guidelines:
• Good Clinical Practice Guidelines
• HIPAA
• The Protection of Human Research Subjects