Clinical Research Coordinator 2

Clinical Research Coordinators (CRCs) support, conduct, coordinate or manage the clinical research studies or trials on human subjects. Principal and co-investigators provide the overall direction in a clinical study, but CRCs can have significant roles in clinical study activities.

Stanford University is one of the world’s most renowned universities. Sitting in the heart of the San Francisco Bay Area among the valley’s most progressive companies.

You will be working with an unparalleled leading-edge community of faculty and staff that are fundamentally changing the world of health care. You will have the opportunity to influence and drive change with your innovative ideas, the ability to make a difference and participate in human advancements. Our culture is fast-paced, energetic, and growing all of the time.

We offer a variety of benefits beyond traditional medical, dental, retirement, and savings options:

• Events and program for children, sports camps, tuition options
• World-class intellectual stimulation through learning and development classes, workshops, and onsite conferences from leading-edge speakers and faculty
• Work/life and family-friendly policies and reimbursement
• Participation in Stanford’s social responsibility and sustainable programs for a better world
• A vibrant university culture that values the uniqueness of each individual

We are seeking candidates who are progressive thinkers, see challenges as simply problems to solve, and have the spirit and energy to change the world.

About the Department of Pathology

Comprised of extraordinary faculty and staff, our mission is to improve the ability to diagnose, treat and understand the origin and manifestation of human disease, and to care for those who have or are at risk to develop disease. We accomplish this through our clinical services (in all fields of anatomic and clinical pathology, including molecular and genomic pathology, histocompatibility testing and transfusion medicine) and be research (which includes basic, translational and clinical research into the origins and manifestations of

disease, including efforts to improve disease prediction and prevention as part of the goal of achieving precision medicine and health), and also by educating future leaders in pathology and related fields. Everything we do is to achieve the goals of providing the highest quality of clinical services to the patients for whom we passionately care, to advance our ability to understand, diagnose, monitor and ultimately to cure disease or to prevent or delay its occurrence, and to provide outstanding education and career development

opportunities to those who share these goals.

For more information about the department visit http://pathology.stanford.edu/

About the Center:

The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is the first of its kind, dedicated to advancing treatments and discovering underlying immune mechanisms to develop lasting cures for allergies and asthma in both children and adults.

Our interdisciplinary team of leading scientists, physician-scientists, and specialists from fields such as immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, and genetics collaborates on cutting-edge research aimed at understanding immune dysfunction that leads to allergic reactions.

As a global leader in allergy research, our Center works collaboratively with researchers worldwide, sharing data through an interlinked network of satellite centers to conduct innovative clinical trials. Our research efforts extend beyond allergies and asthma to encompass a range of immune-related disorders, including eczema, food allergies, eosinophilic conditions, drug allergies, and gastrointestinal diseases.

Through laboratory and computational research, clinical trials, and community outreach, we are committed to developing rational, evidence-based therapies that provide the safest and most effective treatments for patients. By combining innovative science with compassionate care, we strive to transform lives at both local and global levels.

About the Position:

The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is seeking a Clinical Research Coordinator 2 (CRC2) to manage life-changing clinical trials under the direction of project researchers, investigators, or managers.

The CRC2 will join a team of researchers that leads or participates in many clinical trials to develop new therapies for allergic disorders. The studies include a wide range of patients, representing a diverse group of ethnicities and socioeconomic backgrounds including Spanish-speaking participants. The CRC2 will be expected to be fluent in Spanish and able to communicate with Spanish-speaking participants.

The Center is aiming not only to find better treatments for children and adults with allergies and asthma, but to discover underlying immune mechanisms against the diseases and develop a lasting cure. Primary responsibilities as a CRC2 will include the oversight and coordination of complex clinical research trails, management of research coordinator associates and assistant coordinators, including the recruitment of participants, the creation of source documentation, adherence to all ICH/ GCP and HIPAA regulations, management of all

study participants, sample collections, data entry, and administration of the Investigator Site File.

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:

California State License in Phlebotomy

Prior experience in a clinical research setting

Bachelor’s degree in health science, biological sciences, life research, medical technology or clinical research.

Fluent in Spanish

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.

Due to the nature of the work, this position will work 100% on-site.

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.

Qualifications

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• 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.

Responsibilities

• 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.
• 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.
• Minimum Education and Experience
• 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: 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.
• Certificates and Licenses Required
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.