Clinical Research Coordinator

School of Medicine, Stanford, California, United States

Research

Post Date Jun 06, 2024

Requisition # 103543

The Division of Cardiovascular Medicine, within Stanford University Department of Medicine, is a dynamic and innovative center dedicated to excellence in research, medical education, and clinical care. Our Division is driven by over 90 faculty members and a cadre of staff who are the pillar of strength in the Division's ongoing efforts into the prevention and treatment of cardiovascular disease.

We are seeking a Clinical Research Coordinator 2 (CRC-2) who is passionate about clinical research and wants to deliver results. The CRC-2 will have the opportunity to work with a robust clinical research team, hand in hand with the Principal Investigators, Clinical Research Manager and other associates in support of the Interventional Affinity Group and the Structural Heart Research Program.

The successful applicant will have the ability to supervise clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment. Exceptional diplomacy, interpersonal and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes.

If you are interested in supporting translational medicine and contributing to Stanford Medicine’s mission, we invite you to join our team.

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.

DESIRED QUALIFICATIONS:

• Relevant graduate degree and 3 years of experience in clinical research preferred.

• 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.

• Proven ability to work independently and take ownership of a project.

• Proven ability to work collaboratively and cooperatively in a team environment.

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

• Detail oriented with excellent organizational skills.

• Excellent communication skills.

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

• Fluency in Spanish is a plus.

• Clinical research project management experience.

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 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.

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.

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.

WORKING 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 Workwebsite 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.

Why Stanford is for You

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture andunique perksempower you with:

• Freedom to grow . We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.

• A caring culture . We provide superb retirement plans, generous time-off, and family care resources.

• A healthier you . Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.

• Discovery and fun . Stroll through historic sculptures, trails, and museums.

• Enviable resources . Enjoy free commuter programs, ridesharing incentives, discounts and more.

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.

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 at stanfordelr@stanford.edu. For all other inquiries, please submit 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.

Additional Information

• Schedule: Full-time

• Job Code: 4923

• Employee Status: Regular

• Grade: H

• Requisition ID: 103543

• Work Arrangement : Hybrid Eligible