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Clinical Research Coordinator 2
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School of Medicine, Stanford, California, United States • Research • 10 hours ago Post Date • 107839 Requisition #
Benefits
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
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 is the world's leading scientists, physician-scientists, and research teams come together to study and understand the molecular underpinnings of allergies and asthma. We are committed to finding causes, treatments, and cures for allergies and asthma, and bringing these to children, adults, and their families at local and global levels. Transforming lives with innovative science and compassionate care.
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. 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.
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.
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 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.
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.
Due to the nature of the work, this position will work 100% on‑site.
Expected Pay Range 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.
Why Stanford is for You
Freedom to grow. We offer career development programs, tuition reimbursement, or course auditing. 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.
General Job Information
Schedule: Full‑time
Job Code: 4923
Employee Status: Regular
Grade: H
Requisition ID: 107839
Work Arrangement: On Site
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.
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: 107839 Work Arrangement : On Site
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School of Medicine, Stanford, California, United States • Research • 10 hours ago Post Date • 107839 Requisition #
Benefits
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
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 is the world's leading scientists, physician-scientists, and research teams come together to study and understand the molecular underpinnings of allergies and asthma. We are committed to finding causes, treatments, and cures for allergies and asthma, and bringing these to children, adults, and their families at local and global levels. Transforming lives with innovative science and compassionate care.
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. 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.
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.
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 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.
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.
Due to the nature of the work, this position will work 100% on‑site.
Expected Pay Range 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.
Why Stanford is for You
Freedom to grow. We offer career development programs, tuition reimbursement, or course auditing. 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.
General Job Information
Schedule: Full‑time
Job Code: 4923
Employee Status: Regular
Grade: H
Requisition ID: 107839
Work Arrangement: On Site
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.
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: 107839 Work Arrangement : On Site
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