Clinical Research Prog Lead
El Camino Hospital
Mountain View , CA 94035
Posted 1 week ago
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- The Clinical Research Program Lead ensures 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.
This position will provide mentoring and training of new or junior research staff and work with the Director to develop adequate team coverage plans. Contributes to developing educational materials on study coordination and data completion processes for the research program. Prepares clinical research reports for Director, PIs, Service Lines, ECH Leadership and sponsors.
Develops and implements research Standard Operating Procedures (SOPs). Oversees and ensures completeness in appropriate AE and SAE reporting requirements as well as deviation reporting to sponsors and the (spell out when using for the first time) (IRB). In addition, incumbents 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 include supporting the management and coordinating the tasks of multiple clinical research studies, act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; assist PI with protocol preparation; manage Investigator's protocols in the Committee on Human Research, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval. The Clinical Research Program Lead provides transparent, constructive, professional communication with fellow team members to promote uniformity in research across service lines and within the Clinical Research Department. The Lead participates in any internal and external audits or reviews of study protocols and performs other duties as assigned.
1.Bachelor's or advanced degree preferred in nursing, biology or other health science field, operations research, or other related field, or equivalency.
2.Minimum five (5) years' 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.
3.Five (5) years of progressive leadership experience preferably in the clinical research industry.
4.Advanced knowledge and understanding of regulatory guidelines related to human subject research protections in clinical trial investigations.
5.Ability to assess functional processes, workflow and develop documented improvement plans for efficiency and quality output.
6.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.).
7.Clinical Trial Management Software experience (i.e., Clinical Conductor, OnCore, Velos).
8.Demonstrated ability to positively influence others in a team environment.
9.Proactive and critical evaluation of multiple aspects of clinical trial execution Background knowledge of assigned department's area of specialization
10. 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.
11. Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
12. Proficient in Excel, PowerPoint, and graphics programs.
13. 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
Environmental Health and Safety Training
1.Certified Clinical Research Coordinator (CCRC), Association of Clinical Research Professionals (ACRP), or Society of Clinical Research Associates (SOCRA) certifications preferred