Lead Clinical Research Coordinator
Lead Clinical Research Coordinator
Job Number: 78095
The Stanford Center for Clinical Research (SCCR), in collaboration with the Stanford Departments of Medicine and Radiology, is conducting one of the largest, most innovative, longitudinal studies in association with a leading Silicon Valley tech company and multiple high-profile academic partners. SCCR is seeking to hire multiple Lead Coordinators to support this exciting new study involving multiple disciplines, including cardiology, oncology and primary care.
SCCR provides infrastructure and research support to clinical research investigators and staff throughout the Department. Its mission is to promote high-quality, globally impactful clinical research to improve human health by working collaboratively within Stanford University and its affiliates.
The Lead Coordinator will work in a dynamic atmosphere and as part of a large team in a supportive environment. The role will be responsible for supporting multiple staff members, including coordinators and research assistants, physicians, nurses, respiratory therapists, and ophthalmic technicians. The Lead Coordinator will direct the operational logistics, ensure efficient participant flow, manage recruitment pipelines, oversee regulatory compliance, and ensure overall logistical progress on the project. The position will interface with faculty, collaborators, and SCCR senior leadership to report project progress and trouble shoot barriers. Outstanding communication and organizational skills, the ability to proactively manage challenges, and strong attention to detail are required in a successful candidate.
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection.
- Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
- 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.
- Audit operations, including laboratory procedures, 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.
- Manage resources within study budget, working with senior staff and principal investigators, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
- Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
- Ensure Institutional Review Board renewals are completed.
- Excellent leadership and management skills, including several years as a supervisor, mentor, or trainer
- Experience with large, complex, longitudinal research studies is desired
Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Strong interpersonal skills
- Proficiency with Microsoft Office and database applications
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License. A Nursing license is valued, but not required
- 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.
- Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious disease and infections.
- 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 bases 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.
Location: School of Medicine
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
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.