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Stanford University's Department of Neurosurgery is seeking a Clinical Research Coordinator II (CRCII) 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. Studies may include drug/ device trials, longitudinal natural history studies, and other PI-initiated projects dealing with pediatric and adult neuro-Oncology treatments. The CRCII will directly coordinate 2 or more clinical studies, supervise and delegate tasks for 5 or more studies, and work under the close direction of the manager (CRM), regulatory specialist and principal investigator(s). The CRCII will support industry, federal and grant funded clinical research studies. The CRC II will manage 1-3 CRCAs and will be responsible for training, assigning tasks and reviewing their work. This CRC II position is a full-time position, and a commitment of at least two years is required. CRC IIs are expected to be available up to 5 days a week on site. This position may require occasional evening and weekend hours.
Interested candidates, please apply with your resume and a cover letter. Please describe your background, interests, and future goals in the cover letter.
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 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.
• Hybrid Work Agreement.

* Other duties may also be assigned.
DESIRED QUALIFICATIONS:

• Neurosurgery/ Oncology clinical trial coordination experience working with adults and children.
• Investigator Initiated clinical trial coordination experience.
• Experience with local and single-IRB submissions.
• Experience with protocol drafting and IND/IDE documents.
• Experience working with various databases such as REDCap, Oncore and various EDC systems.
• Knowledge of data-related research and presentation of research data.
• Enjoy working directly with patients and their families.
• Exceptionally organized and can balance multiple projects at once.
• Have the necessary patience and resourcefulness to interact well with individuals and their families.

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, including the ability to work easily with research participants and research team members.
• Strong general computer skills and ability to quickly learn and master computer programs.
• Proficiency with Microsoft Office and Adobe.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. IRB submissions.
• 2-4 years clinical research coordinator experience.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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 $86,248 to $100,158 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.
Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form.
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.