The Department of Anesthesiology, Perioperative, and Pain Medicine, at Stanford University’s School of Medicine, is a world-leading department that offers comprehensive training and perioperative patient care, pain management, and critical care medicine as well as cutting-edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education.
The Department of Anesthesiology, Perioperative, and Pain Medicine is seeking a Clinical Research Coordinator 2 (Fixed-term 12 months) to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.
The Brown laboratory focuses on understanding and preventing delirium and cognitive decline after surgery. First, a large focus of this position will be to spearhead the development and conduct of a new 4-center observational study to enroll patients undergoing aortic surgery with the goal of understanding mechanisms of postoperative neurocognitive dysfunction. Patients will undergo remote neuropsychological assessments by computer, in-person delirium assessments, and will have serial cerebrospinal fluid and blood samples collected from existing catheters and processed. At Stanford, patient-facing activities may occur at odd hours based on the surgical schedule and are anticipated to include approximately 4 consecutive days per patient, with 1-2 patients enrolled per month. The CRC-2 will help develop the study processes and protocols, will lead all patient-facing (e.g. surveys, sample collection) and data extraction tasks at Stanford (in collaboration with the PI and other staff), and will coordinate the processes to ensure study conduct at the other sites (in coordination with the PI). Second, the CRC-2 may assist in other similar cohort studies with similar goals (e.g. enrolling, delirium assessments, sample collection) and/or the development of new studies. Third, the CRC-2 will assist in managing, exploring, and interpreting data from other studies that is already available, in coordination with the PI and data analysts. Overall, the CRC-2 will be the lead for all regulatory responsibilities (IRB, NIH reporting, etc.). The CRC-2 will participate in other duties as needed with the overall goal of developing and conducting patient-enrolled studies or analyses of existing data to improve the perioperative care of older adults undergoing surgery.
At Stanford University School of Medicine, the work we do touches the lives of those today and tomorrow. Through education, research, and health care, the School of Medicine improves health through leadership, diversity, collaborative discoveries, and innovation in health care. Whether working in departments with faculty, or in units that support the school, our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health.
Stanford is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends, and benefits that increase financial stability and promote healthy, fulfilling lives. An award-winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers.
The School of Medicine and the Department of Anesthesia are committed to diversity, equity, and inclusion for its faculty, staff, residents, postdocs, and fellows. We aim to recruit, support, retain, and promote diversity in our department.
For more information on our department, please see our website: https://med.stanford.edu/anesthesia.html.
Duties include:
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Provide leadership and coordination for a four-center observational cohort study.
- Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
- 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.
- Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
- Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
- Develop study budget with staff and principal investigator, 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.
- Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
- Completion of patient reported outcome forms.
- Delirium assessments at bedside.
- Collection, processing, and tracking of patient biological samples.
- Interface with online platform for neuropsychological assessments.
- Provide leadership in coordinating a multi-center observational study.
* - Other duties may also be assigned
DESIRED QUALIFICATIONS:
- Knowledge of principles of clinical research and federal regulations.
- Willingness to adapt schedule to be in the hospital for patient assessments of sample collection/processing based on study needs.
- Ability to effectively work in a fast-paced environment with multiple projects and timelines.
- Familiarity with IRB guidelines and regulations.
- Previous experience with REDCap or other related database applications.
- Previous experience working with surgical patients is desired but not required.
- Minimum of two years related experience.
- Fast Learner.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Strong interpersonal skills.
- Proficiency with Microsoft Office and database applications (Redcap).
- 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.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver’s License.
PHYSICAL REQUIREMENTS*:
- 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.
WORKING CONDITIONS:
- 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 diseases and infections.
- May require extended or unusual work hours based on research requirements and business needs, including weekends or early or late hours. These requirements will be known several days in advance and can be discussed.
WORK 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.
