Stanford University School of Medicine
Clinical Research Coordinator 2 (Hybrid Opportunity)
Stanford University School of Medicine, Stanford, California, United States, 94305
Clinical Research Coordinator 2 (Hybrid Opportunity)
The Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is seeking a Clinical Research Coordinator 2 (CRC2) to conduct clinical research and work independently on progressively more complex projects and assignments. This role will involve independently managing significant and key aspects of a large study or all aspects of one or more small research studies.
The Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is comprised of a team of outstanding clinicians, scientists, and scholars dedicated to improving the lives of patients with serious lung disease. Our goal is to provide outstanding clinical and research training to the next generation of leaders in Pulmonary and Critical Care Medicine. We are committed to strong clinical investigations, including the evaluation of new pharmacologic agents and outcome studies characterizing clinical parameters to effect positive changes in patient care.
This is a hybrid eligible position.
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.
Desired Qualifications
Demonstrate sound judgement and problem‑solving skills that will protect volunteer safety and promote highest standard of clinical trial compliance.
Ability to organize work and multi‑task.
Exceptional attention to detail.
Ability to produce timely and accurate reports to monitor regulatory and clinical processes.
Practical knowledge and experience with internal School of Medicine clinical trial standards, including SPECTRUM, Patient Financial Services, HSSC and ISO data safety and security best practices.
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/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.
Benefits
Freedom to grow: career development programs, tuition reimbursement, audit a course, and opportunities to attend conferences.
A caring culture: superb retirement plans, generous time‑off, and family‑care resources.
Health and fitness: world‑class exercise facilities and health‑care benefits.
Discovery and fun: historic sculptures, trails, and museums.
Enviable resources: free commuter programs, ridesharing incentives, discounts, and more.
Pay Range $86,248 to $100,158 per annum. The pay offered to a selected candidate will be determined based on factors such as scope and responsibilities of the position, qualifications, departmental budget, internal equity, geographic location and external market pay for comparable jobs.
Equity and EEO Statement 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.
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.
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The Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is comprised of a team of outstanding clinicians, scientists, and scholars dedicated to improving the lives of patients with serious lung disease. Our goal is to provide outstanding clinical and research training to the next generation of leaders in Pulmonary and Critical Care Medicine. We are committed to strong clinical investigations, including the evaluation of new pharmacologic agents and outcome studies characterizing clinical parameters to effect positive changes in patient care.
This is a hybrid eligible position.
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.
Desired Qualifications
Demonstrate sound judgement and problem‑solving skills that will protect volunteer safety and promote highest standard of clinical trial compliance.
Ability to organize work and multi‑task.
Exceptional attention to detail.
Ability to produce timely and accurate reports to monitor regulatory and clinical processes.
Practical knowledge and experience with internal School of Medicine clinical trial standards, including SPECTRUM, Patient Financial Services, HSSC and ISO data safety and security best practices.
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/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.
Benefits
Freedom to grow: career development programs, tuition reimbursement, audit a course, and opportunities to attend conferences.
A caring culture: superb retirement plans, generous time‑off, and family‑care resources.
Health and fitness: world‑class exercise facilities and health‑care benefits.
Discovery and fun: historic sculptures, trails, and museums.
Enviable resources: free commuter programs, ridesharing incentives, discounts, and more.
Pay Range $86,248 to $100,158 per annum. The pay offered to a selected candidate will be determined based on factors such as scope and responsibilities of the position, qualifications, departmental budget, internal equity, geographic location and external market pay for comparable jobs.
Equity and EEO Statement 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.
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.
#J-18808-Ljbffr