Clinical Research Coordinator 3

The Stanford Department of Pediatrics, Division of Rheumatology is seeking a skilled, detail-oriented, motivated, collaborative Clinical Research Operations Assistant Director (CRC3) to join the Immune Behavioral Health/ PANS Research Team. The Stanford Immune Behavioral Health (IBH) Clinical Research Program operates adjacent a pediatric multidisciplinary clinic established in 2012 to care for patients with infection-associated neuropsychiatric deteriorations and co-morbid inflammatory conditions (i.e. arthritis, vascular inflammation, etc) symptoms. Led by PI Dr. Jennifer Frankovich, the research program collects longitudinal clinical data and biospecimens to carry out research looking at the immune system, proteomics, microbiome, metabolomics, and genomics at Stanford and with collaborators/ basic scientists globally with the ultimate goal of better understanding the underpinnings of illness and improving diagnosis, care, and treatment for affected individuals.

The Program’s hopeful Clinical Research Operations Assistant Director will work under the general direction of faculty and alongside leadership to develop, implement, and administer the vision, strategy, and goals of the assigned academic entity/program(s). Incumbent will provide operational and scientific leadership for the clinical research program. The role will oversee the current clinical database and biorepository; coordinate alignment with the new Aurora database; direct data-field design, validation, and cleaning; maintain database and biorepository SOPs; and oversee data and sample intake across current (Menlo Park) and any future sites. The incumbent will also oversee the Healthy Control Project, clinical research space and specimen storage, and 2-3 research assistants supporting database, biorepository, compliance, sample-distribution, and study activities.

Additional responsibilities include directing approved sample distributions and timelines; overseeing clinical data analyses and clinical-characteristics tables; coordinating annual IRB renewals, updates, amendments, and new submissions; and leading development, distribution, analysis, refinement, and publication of Delphi consensus questionnaires. The incumbent will design and implement new clinical studies, train study personnel, interpret results, and lead or contribute to abstracts, presentations, manuscripts, and grant applications. The role will provide clinical perspective to epidemiologists and basic scientists, coordinate student engagement with program leadership, and progressively assume responsibility for monitoring and managing the clinical research budget. The successful candidate will be highly organized, analytically strong, proactive, collaborative, and committed to research integrity, participant confidentiality, and a positive working environment.

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.
• Monitor and 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.
• Supervision of staff or students, as assigned, including hiring, performance management and coaching; mentoring and training of staff and assistance with preparation of performance evaluations for staff who do not directly report to this role, and performing related duties, in addition to instruction on project work.
• Audit operations, including performing internal monitoring, 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. May have specialization such as leading training for the group, leading quality program for the group or other specialized and more complex responsibilities.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries. Analyze completed study results to aid PI in the development of recommendations to enhance quality outcomes.
• 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. Develop and manage the financial timeline and personnel resources; may oversee post-award deliverable.
• Ensure regulatory compliance. Regularly inspect study documents 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.
• Write and edit content for proposals, peer-reviewed publications, and other program activities under the general direction of PI. Assist with the development of research grants, (i.e., may suggest new funding opportunities, write portions of grants, and/or summarize data for grant support), and consensus building efforts/publications.

  • - Other duties may also be assigned

  • This is an on-site (Palo Alto, CA), fixed term position for one (1) year at 100% FTE. The program will also consider hiring as hybrid. Opportunity for renewal based on funding availability.

  • To learn more about the lab and PI , please visit: https://med.stanford.edu/pans.html

  • The expected pay range for this position working in the California Bay area is anticipated to be $108,000-111,000 annually (??)

  • Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the University reasonably expects to pay for a position upon hire. 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.

  • DESIRED QUALIFICATIONS:

  • PhD or advanced degree in relevant research area (neuropsychiatry, immunology, and/or epidemiology) and four or more years of relevant experience and training.
  • Candidates should have a background in clinical research, neuroscience, immunology, epidemiology, biostatistics, or another similar discipline, with extensive experience working in a clinical research environment
  • Doctoral-level training in clinical research, epidemiology, biostatistics, public health, psychology, or a related field.
  • Prior experience directing projects in the clinical research environment including: supervising research assistants, directing compliance, directing specimen collection/biobanking, directing SOP development, directing protocol development, directing relational database including data-quality workflows, developing studies from beginning to end).

  • Demonstrated ability to supervise and develop research staff

  • Demonstrated experience maintaining rigorous standards for data quality, specimen stewardship, confidentiality, and regulatory documentation.

  • Experience in directing the design and implementation of clinical studies; developing analysis plans; interpreting clinical data; preparing clinical-characteristics tables; and contributing to grants, scientific presentations, consensus projects, and peer-reviewed manuscripts. Must have at least 3 first author papers in a peer-reviewed journal based on original research led by the applicant.

  • Experience with research budgets and interdisciplinary collaboration is preferred.

  • EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in a related field and four years of experience in clinical research, or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Excellent oral, written, and analytical skills, exhibiting fluency in our area of specialization (neuropsychiatry and immunology)

• Excellent interpersonal skills.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Demonstrated project/program leadership skills with experience and ability to mentor and manage team of students, staff, interns

• Ability to Maintain strict confidentiality of all study subjects

• Ability to develop program partnerships and funding sources.

• Assist with and direct new research proposals and applications for funding and grants.

• Lead preparation of papers for publication. May be a co-author on publications. Present ongoing work and findings to colleagues at academic conferences.

• Perform ongoing literature review to remain current with new procedures and related research; propose new research directions based on new advances discussed in literature.

• Must be intellectually curious, have strong problem-solving skills, critical thinking skills, and attention to detail.

• Strong analytical skills and excellent judgment.

• Ability to prioritize workload, adjust timelines, work under deadlines, and shift priorities based on program and scientific collaborators (with general guidance) is essential.

• Excellent organizational skills and demonstrated ability to complete detailed work accurately and thoroughly.

• Project management skills including ability to coordinate multiple studies and stakeholders; establish priorities and timelines

• Contribute to a positive working environment

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. CITI.

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.
• Extensive computer work- ability to remain at desk/on computer during perform desk-based computer tasks for lengthily periods of time (keyboarding, dexterity)

• Ability to use voice to present information/communicate with others.

• On-campus mobility

• Occasionally utilize the telephone

* - 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.

Additional PHYSICAL REQUIREMENTS: (remove if none)

WORKING CONDITIONS:

• Work will be conducted in an administrative office setting and in a pediatric clinic
• May work extended/ non-standard hours, evenings or weekends in support of research or project work
• May be exposed to blood borne pathogens.
• May travel locally- rare overnight travel

Core Duties:

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.

• Monitor and 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.

• Supervision of staff or students, as assigned, including hiring, performance management and coaching; mentoring and training of staff and assistance with preparation of performance evaluations for staff who do not directly report to this role, and performing related duties, in addition to instruction on project work.

• Audit operations, including performing internal monitoring, 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. May have specialization such as leading training for the group, leading quality program for the group or other specialized and more complex responsibilities.

• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries. Analyze completed study results to aid PI in the development of recommendations to enhance quality outcomes.

• 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. Develop and manage the financial timeline and personnel resources; may oversee post-award deliverable.

• Ensure regulatory compliance. Regularly inspect study documents 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.

Minimum Education:

Bachelor's degree in a related field

Minimum Experience:

Four years of experience in clinical research, or an equivalent combination of education and relevant experience.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Proficiency in 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.

• Demonstrated project/program leadership skills.

• Demonstrated disease knowledge / study design experience of studies under purview.

Certificates and Licenses Required

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

[REMOVE STATEMENT BEFORE POSTING - KEEP LANGUAGE BELOW, IF APPLICABLE. REMOVE IF NOT APPLICABLE]

Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver's License.

• Ability to drive day or night.

• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.