The Stanford Center for Clinical Research (SCCR), in collaboration with the Stanford Departments of Medicine, Neurosurgery, Bioengineering and Radiology, is conducting large, innovative longitudinal studies. SCCR is seeking to hire a Clinical Research Operations Specialist I to support duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the principal investigator and/or study Operations Manager.
SCCR provides infrastructure and research support to Stanford clinical research investigators. Its mission is to conduct and promote high-impact, innovative clinical research to improve human health.
The Clinical Research Operations Specialist will work within a multidisciplinary team, including physicians, athletic trainers, and coaches; and have direct interaction with participants. The Clinical Research Operations Specialist is required to have the ability to multi-task in a high-energy environment. This position may involve traveling to study sites and being able to attend the athletic games and practice sessions. The Clinical Research Operations Specialist is required to have flexibility in their work schedule and outstanding communication and organizational skills with attention to detail. The study visits may occur in the evenings and occasionally during weekends. The Clinical Research Assistant will be responsible for ensuring compliance with federal, state, local, and sponsor regulations and work under the direction of their supervisor.
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
Collect and manage patient data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
Participate in monitor visits and regulatory audits.
Perform site trainings and ensure research staff conduct and perform study assessments as per applicable regulations and SOPs.
* - Other duties may also be assigned
EDUCATION & EXPERIENCE (REQUIRED):
Two year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant 1-2 years clinical research experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
* - 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.
Occasional evening and weekend hours.
May be required to drive (required to possess a valid CA driver's license)
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.
Job Family: Research Job Series: Clinical Research Coordinator Job Code: 4924 Grade: F Exemption: Non-exempt Schedule: Full-time Additional Information
Location: School of Medicine, Stanford, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
Copyright 2017 Jobelephant.com Inc. All rights reserved.
Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 12000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford is an equal empl...oyment 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. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.