Clinical Research Operations Specialist I
Clinical Research Operations Specialist I🔍School of Medicine, Stanford, California, United States📁Research📅Oct 16, 2020 Post Date📅87565 Requisition #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. Duties include:
- 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 and laboratory 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.
- Ensure research staff conduct and perform study assessments as per applicable regulations and SOPs.
- 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 experience.
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
- 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.
- Occasional evening and weekend hours.
- 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, https://adminguide.stanford.edu.
Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
- Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
- A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
- A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
- Discovery and fun. Stroll through historic sculptures, trails, and museums.
- Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.
- Schedule: Full-time
- Job Code: 4924
- Employee Status: Regular
- Grade: F
- Requisition ID: 87565