Clinical Event Committee Specialist
The Stanford Center for Clinical Research (SCCR) is a rapidly growing academic research organization within the Stanford Department of Medicine. Our mission is to conduct and promote high-impact, innovative clinical research to improve human health.
SCCR seeks a mission-driven Clinical Event Committee Specialist.
You will work with a high-performing team of clinical operations staff and clinical experts. Responsibilities will include ensuring compliance with GCPs and SOPs, and collaborating with clinical operations, finance, quality, education and business development managers. You will collaborate closely with the senior research manager, CEC, to train staff and ensure we can be nimble when needed and that resources can accommodate the natural ebbs and flow of clinical event committee projects.
The ideal candidate has significant experience in the operations of clinical event/endpoint committees also known as endpoint adjudication committees. You will also have exceptional interpersonal, communication and diplomacy skills. Additional qualifications include the ability to manage multiple projects. You will also have clinical research monitoring experience and have worked directly with clinical experts and industry sponsors. High integrity, and a commitment to excellence and continuous improvement is essential.
At SCCR, we strive to find team members who are passionate about their work, flexible, fun, and want to deliver results. We place a high priority on equipping our staff to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team to have a healthy balance between work commitments and life outside of work, and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research, we encourage you to apply!
Learn more about our work and core values: www.med.stanford.edu/sccr
- Develop event adjudication charter document, event review forms, and project tracking report templates to be used during endpoint review process. Assist in the development of study-specific endpoints and list of associated source documents
- Collection ad review of required documentation associated with each event before its submission to the CEC for review.
- Assist with training of the CEC members and be the point of contact for the CEC members for any study related queries.
- Follow-up with study sites to obtain additional supporting documentation for potential endpoints or events. Also provide appropriate follow-up with the study site to ensure that all potential endpoints or events have been reported
- Play a lead role in the preparation, scheduling and coordination of periodic CEC member meetings. Also attend the committee meetings as a facilitator.
- Develop CEC project budget with staff and principal investigator and track project specific milestones, and invoice sponsors according to project contract.
- Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
- Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
- Develop project schedules, targets, measurements, and accountabilities, as assigned.
- Support audit operations, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
- Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
- * - Other duties may also be assigned.
- DESIRED QUALIFICATIONS:
- Demonstrated excellent communication skills in speaking and writing
- Multi-site clinical trial management experience
- Project management experience
- 2-4 years of clinical research experience is a plus
- The incumbent should be very comfortable working independently and with minimal supervision
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor’s degree and three years of related experience or a combination of relevant education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Excellent communication skills and superb attention to detail.
- Experience with MS Office products and database applications required.
- Excellent inter-personal skills and customer service focus is required.
- Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.
- Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
- Strong writing skills.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver’s License.
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
- Occasionally sit, use a telephone or write by hand.
- Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
May require extended or unusual work hours based on research requirements and business needs.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
- Schedule: Full-time
- Job Code: 4941
- Employee Status: Regular
- Grade: H
- Requisition ID: 85568