Clinical Research Coordinator – Interventional Endoscopy

The distinguished Paul May and Frank Stein Interventional Endoscopy Center is the premier referral center in Northern California and the greater region for patients requiring complex endoscopic therapy. Led by Dr. Kenneth Binmoeller, who founded the Interventional Endoscopy Services (IES) program at California Pacific Medical Center in 2001, the Center provides the most advanced minimally invasive approach that endoscopy affords, providing an enormous benefit to patients as well as substantial healthcare cost savings. The center is dedicated to providing exceptional patient care, developing and performing innovative endoscopic treatments, and conducting cutting-edge medical research. We are currently seeking a highly qualified CRC to join this center, where you will play a vital role in coordinating and managing research activities within our interventional endoscopy program, contributing to the development of new interventions and improving patient outcomes.

The Clinical Research Coordinator (CRC) will join the California Pacific Medical Center Division of Interventional Endoscopy to manage clinical research studies related to innovative advanced endoscopic interventions and their associated outcomes. This individual will oversee and implement multiple clinical studies under research protocols developed in conjunction with Principal Investigators (PIs) and the CPMC Research Institute. The ideal candidate will have a strong background in clinical research, with specific expertise in procedural outcomes research.

In addition to management and coordination of multiple clinical research studies, the CRC will oversee data and specimen management, create research protocols, write and submit protocols for Institute Review Board approval, craft reports of study results, assist in comprehensive dataset development and management, support assistant CRC training, update protocol applications for renewal and modification, provide progress reports to study investigators, maintain quality control procedures to ensure data integrity and regulatory compliance. 

Job Responsibilities:

1. Study Coordination and Data Collection

• Identify, screen, and enroll potential subjects
• Develop and implement strategies for subject recruitment
• Obtain informed consent for research studies
• Work with PI and other investigators to ensure study protocol compliance
• Data extraction from medical records and patient interviews
• Prospectively monitor procedure outcomes and complications
• Monitor outcomes of follow-up procedures

2. Data Management and Result Reporting

• Timely data collection and database entry
• Maintain complete and accurate records
• Database creation and modification
• Query and analysis of existing data sets
• Attend regular Division of Interventional Endoscopy meetings to provide work in progress updates
• Assist in staff training regarding data collection and entry
• Assist in procedure video cataloguing and editing for research reporting

3. Research sub-investigator training

• Oversight of clinical resident and fellow research projects

4. Quality Control

• Maintain data accuracy and consistent, replicable data collection processes
• Develop and maintain quality audit process

5. Study Conduction

• Employ various data collection methods and processes
• Automate prospective data collection where possible
• Maintain process for study subject tracking 

6. Specimen Collection and Biobank

• Work with relevant Sutter, CPMC, and inter-institutional biobanks for specimen storage and analysis when appropriate for research study
• Maintain process for specimen tracking
• Work with relevant clinical division to attain radiologic and pathologic specimen interpretation information

7. Protocol Generation and Compliance

• Protocol Creation and Submission to Institutional Review Board
• Work with the CPMC Interventional Endoscopy Data Analyst to create data collection methods and electronic entry forms
• Generation of manuscripts for submission in collaboration with PI and sub-Investigators
• Renew and modify existing research protocols
• Monitor expiration dates of existing research protocols
• Monitor study progress, enrollment numbers
• Ensure adherence to protocol requirements and deadlines and address any deviations
• Monitor study progress, enrollment numbers,

8. Regulatory Compliance

• Ensure studies are conceived and applied in compliance with IRB, institutional, state, and federal regulations
• Store and maintain regulatory documents
• Prepare necessary documents for internal and external regulatory audits
• Ensure adherence to protocol requirements and deadlines
• Ensure compliance with ethical and legal patient privacy requirements throughout study development, implementation, and post-study reporting 

Qualifications:

Required

• Excellent organizational skills
• Independently motivated and self-directed to balance multiple projects and complete them in timely fashion
• Strong written and verbal communication skills for cordial, effective interaction with study subjects and institutional staff
• Interest in clinical or research-based medical career
• 2-year commitment
• BA or BS degree in life sciences or pre-health field (MD and/or PhD preferred)
• 1 year of clinical research experience
• Experience with Epic EMR
• Experience with database management
• Strong knowledge of research methodologies, data collection techniques, and regulatory requirements

Preferred:

• Experience with database management
• Experience in statistical analysis in outcomes research
• Master’s degree in life science or health-related field
• Experience working in a healthcare or academic research setting, preferably with exposure to endoscopic procedures and gastrointestinal disorders
• Prior experience with clinical trial management, protocol development, and IRB submission is highly desirable.