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Inside Higher Ed · 1 week ago

Clinical Research Coordinator 2 – Surgical Planning

Stanford, CA

Full-time

Onsite

Mid, Senior Level

$86K/yr - $100K/yr

2+ years exp

Stanford University is seeking a Clinical Research Coordinator 2 as part of the new Surgical Planning Clinical service. This role involves providing leadership and oversight for clinical research projects, managing operations, ensuring regulatory compliance, and collaborating with various professionals to support complex scientific and research programs.

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Responsibilities

Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials

Supervise the implementation of and adherence to study protocols

Educate research staff on established policies, processes, and procedures

Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials

Develop consent forms for approval by Human Subjects Panel

Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies

Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies

Submit Investigational New Drug applications to the FDA as required

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 and expertise in identifying and completing research grants

Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group

Lead or chair committees or task forces to address and resolve significant issues

Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences

Analyze trends in recruitment and assure there is a limited number of competing trials

Make recommendations for a variety of options within a trial; track physician compliance

Assist with analysis of data and preparation of manuscripts and scientific presentations

Support complex scientific and research programs; analyze data, monitor and oversee experimental process, and design and develop prototypes, specialized equipment, and/or systems

Collaborate with scientists, engineers, surgeons, clinicians or senior administrative officers to oversee complex non-routine analyses, select optimum solutions, design and develop special purpose equipment and/or systems, and perform corrective modifications to equipment and system designs

Contribute to or may have lead responsibility for the planning, design, and implementation of scientific, clinical or engineering initiatives, and work toward project objective

Oversee and make decisions independently for operation, maintenance, and development of laboratory space and clinical program

Oversee and prepare periodic financial and technical reports and operating plans

Lead all negotiations with billing and insurance with regards to program activities reimbursement

Establish, communicate, and enforce compliance with health and safety policies and procedures

Oversee development of training manuals and safety guidelines, and train new instrumentation users, researchers, and/or technical staff

Qualification

Clinical research managementRegulatory complianceData analysisProject managementMechanical engineeringBiomedical engineeringSoftware engineeringImage analysisTeam leadershipMicrosoft OfficeTrainingInterpersonal skillsCommunication skillsAttention to detailMentoring

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

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

Demonstrated managerial experience

Demonstrated knowledge and skills of advanced scientific or engineering principles and practices

Extensive experience applying complex scientific and engineering principles and performing special technical services and the ability to articulate and translate implementation requirements to the planning, design, development, operations, and performance of complex equipment and systems

Demonstrated ability to oversee, maintain, and develop a laboratory space including demonstrated ability to and supervise the work of technicians and other staff associated with the group

Demonstrated ability to critically review research proposals, evaluate research capabilities, and make recommendations

Demonstrated ability to establish, communicate, and enforce compliance with health and safety policies and procedures

Demonstrated ability to effectively supervise and train a diverse work staff

Demonstrated ability to contribute to health care policy formulation when working in partnership with a multidisciplinary team of health care providers

Demonstrated ability to delegate responsibly to others, activities according to ability, level of preparation, the standards of practice and regulatory guidelines

Demonstrated ability to develop programs and lead process improvement projects

Demonstrated ability to establish the strategic direction and business plans for a functional group

Demonstrated ability to initiate and implement change conducive to the improvement of the quality and safety of patient care delivery

Demonstrated ability to supervise, coach, mentor, train, and evaluate work results

Demonstrated ability to communicate effectively, both orally and in writing

Demonstrated ability to establish and maintain effective relationships with widely diverse groups, including individuals at all levels both within and outside the organization and gain their cooperation

Demonstrated ability to plan, organize, prioritize, work independently and meet deadlines

Preferred

Significant prior research and management experience, preferably in an engineering or cardiovascular-related field

Background in mechanical engineering, biomedical engineering, bioengineering, computer science or related quantitative and or health field

Strong engineering fundamentals in fluid and solid / continuum mechanics, numerical methods, and/ or computational science, preferably with a PhD in engineering or related field

Solid software engineering skills including as programming in Python and / or Matlab

Experience with CAD software and/or 3D modeling software

Familiarity with image analysis (3D Slicer, Mimics) or medical imaging

Experience running engineering simulations and performing associated analysis of simulation results. This includes finite element methods or computational fluid dynamics (Simvascular). Confidence with troubleshooting simulation results to ensure high quality outputs is needed

If coming from an engineering-oriented background, basic knowledge of anatomy/physiology are recommended

Advanced writing and reading ability, which could be demonstrated via prior publications

Knowledge of cardiovascular/cardiopulmonary anatomy & physiology. Developmental biology knowledge may also be beneficial as our work focuses on congenital heart diseases

Prior experience leading a team and project management working in a multidisciplinary environment, including excellent communication skills

Ability to independently develop efficient workflows for performing computational modeling and simulation in a fast-paced clinical setting

Excellent attention to detail and ability to implement quality assurance protocols for image segmentation and simulation results

Society of Clinical Research Associates or Association of Clinical Research Professionals certification

Benefits

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position.

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.