The Stanford Center for Clinical Research (SCCR) is a 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 Research Operations Specialist (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. This position is onsite.
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!
Duties include:
- Independently develop, draft and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies.
- Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
- Facilitate and participate in committee meetings, ensure procedures are followed. Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate.
- Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions.
- Collaborate on development of standard operating procedures, trainings, and documentation. May participate in delivering trainings.
- Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff and recommend related changes to leadership.
- May serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.
DESIRED QUALIFICATIONS:
- Demonstrated excellent communication skills in speaking and writing.
- Multisite clinical trial management experience.
- Some project management experience.
- 2-4 years of clinical research experience is a plus.
- Comfortable working independently.
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor’s degree and three years of related experience or a combination of education and relevant 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.
PHYSICAL REQUIREMENTS:
- 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.
WORKING STANDARDS:
- 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/.
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
