Lead Clinical Research Coordinator (Fixed-term 2 years)

School of Medicine, Stanford, California, United States

Research

Post Date Aug 26, 2024

Requisition # 104378

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 Berger lab at the StanfordDepartment of Anesthesiology, Perioperative, and Pain Medicine,is seeking a Clinical Research Coordinator 2 (Fixed-term 2 years) 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 Berger lab focuses on elucidating the underlying mechanisms of postoperative neurocognitive disorders such as delirium among older surgical patients, and clarifying the relationships (and potential overlaps) between these disorders and Alzheimer’s Disease and Related Dementias. We are also interested in studying how the APOE4 allele contributes to synapse loss and an increased risk of Azlheimer’s Disease and Related Dementias, use a life course/lifespan approach across the full adult human age range.

Towards these goals, we use a transdisciplinary approach that combines elements of cognitive/systems neuroscience, molecular/cellular neuroscience, as well as elements from the clinical specialties of psychiatry, neurology, anesthesiology and geriatric medicine. We use a wide variety of research tools from these different disciplines, ranging from electroencephalography (EEG), functional MRI imaging, molecular and cellular biomarker assays, genetics and epigenetic assays, as well as cognitive testing, delirium screening, and anesthetic pharmacology studies. The CRC2 will oversee studies that use all of these methods, and will formally supervise entry-level clinical research staff and undergraduate/master’s level students.

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.

• 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.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Knowledge of principles of clinical research and federal regulations.

• Ability to effectively work in a fast-paced environment with multiple projects and timelines.

• Familiarity with IRB guidelines and regulations.

• Previous experience with REDCap/Qualtrics or other related database applications.

• Previous experience working with surgical patients is desired but not required.

• Experience/knowledge of neuroimaging, and cognitive and/or molecular/cellular neuroscience.

• 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, etc).

• 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.

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.

The expected pay range for this position is $69,100 to $92,000 per annum.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Additional Information

• Schedule: Full-time

• Job Code: 4923

• Employee Status: Fixed-Term

• Grade: H

• Requisition ID: 104378

• Work Arrangement : Hybrid Eligible