CLINICAL RESEARCH PROGRAM LEAD
El Camino Hospital, a non-profit organization with hospital campuses in Mountain View and Los Gatos, California, has been serving communities in the south San Francisco Bay Area for nearly 50 years. We have maintained our preferred workplace status by blending cutting-edge technology with high-quality patient care. Currently, we have an exceptional opportunity for a Clinical Research Program Lead to ensure that research at El Camino Hospital is conducted within protocol compliance and regulatory guidelines.
Duties include ensuring that ECH is providing quality source documents and data to sponsors, routinely monitoring compliance with eligibility, protocol requirements and data submission completion, while monitoring delinquency rates and outstanding query resolution across the research program. The incumbent will provide mentoring and training of new or junior research staff; work with the Director to develop adequate team coverage plans; contribute to developing educational materials on study coordination and data completion processes for the research program; prepare clinical research reports for Director, PIs, Service Lines, ECH Leadership and sponsors; develop and implement research Standard Operating Procedures (SOPs); and oversee and ensure completeness in appropriate AE and SAE reporting requirements, as well as deviation reporting to sponsors and the IRB. In addition, the incumbent will be expected to execute, manage and coordinate a portfolio of research protocols in the clinic settings with an emphasis on the scheduling, screening, enrollment and monitoring of patient candidates/participants. Duties may also include supporting the management and coordinating the tasks of multiple clinical research studies, serving as intermediary between services and departments while overseeing data and specimen management; managing and reporting on study results; creating, cleaning, updating and managing databases and comprehensive datasets and reports; assisting PI with protocol preparation; managing Investigator's protocols in the Committee on Human Research, as well as renewals and modifications of protocol applications and the implementation of new studies; and participating in the review and writing of protocols to ensure institutional review board approval. The Clinical Research Program Lead will provide transparent, constructive, professional communication with fellow team members to promote uniformity in research across service lines and within the Clinical Research Department, as well as participate in any internal and external audits or reviews of study protocols.
- Bachelor's or advanced degree preferred in nursing, biology or other health science field, operations research, or other related field, or equivalency
- Minimum five years of experience and demonstrated skills to successfully perform the assigned duties and responsibilities, i.e. coordinating research projects under specific guidance, training and/or experience in research methodology/research study design, hypothesis testing; OR experience in clinical trials protocols involving research methodology/research study design and hypothesis testing
- Five years of progressive leadership experience, preferably in the clinical research industry
- Advanced knowledge and understanding of regulatory guidelines related to human subject research protections in clinical trial investigations
- Ability to assess functional processes, workflow and develop documented improvement plans for efficiency and quality output
- Advanced knowledge of industry standards related to clinical trial coordinator functions and study data management activities (i.e., complex trial designs, data standards, data reviews, etc.)
- Clinical Trial Management Software experience (i.e., Clinical Conductor, OnCore, Velos)
- Demonstrated ability to positively influence others in a team environment
- Proactive and critical evaluation of multiple aspects of clinical trial execution
- Background knowledge of assigned department's area of specialization
- Attention to detail; strong interpersonal and collaborative skills; excellent, effective verbal and written communication skills and the 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
- Proficient in Excel, PowerPoint and graphics programs
- Experience applying the following regulations and guidelines: Good Clinical Practice Guidelines, Health Insurance Portability and Accountability Act (HIPAA), the Protection of Human Research Subjects, CHR regulations for recruitment and consent of research subjects, Environmental Health and Safety Training
Certified Clinical Research Coordinator (CCRC), Association of Clinical Research Professionals (ACRP), or Society of Clinical Research Associates (SOCRA) certifications preferred.
If you're looking for an enriching and professionally supportive environment, please apply online at http://www.elcaminohospital.org.
Equal Opportunity Employer