Inside Higher Ed
Clinical Research Manager (6-Month Fixed-Term) (Hybrid Opportunity)
Inside Higher Ed, Palo Alto, California, United States, 94306
Clinical Research Manager (6-Month Fixed-Term) (Hybrid Opportunity)
Stanford University is seeking an experienced and collaborative Clinical Research Manager (CRM) to join our expanding clinical research program in the Division of Pulmonary, Allergy, and Critical Care Medicine (PACCM) for a 6-month fixed-term position. This is an opportunity to work in an intellectually stimulating and collaborative research environment focused on the care of patients with lung diseases from a variety of causes.
Duties
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators.
Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
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.
Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
Lead or chair committees or task forces to address and resolve significant issues.
Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
Assist with analysis of data and preparation of manuscripts and scientific presentations.
Education & Experience (required)
Bachelor’s degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master’s degree preferred.
Knowledge, Skills and Abilities (required)
Excellent 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.
Demonstrated managerial experience.
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.
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.
Pay Range $124,521 to $153,615 per annum.
Benefits
Freedom to grow. Career development programs, tuition reimbursement, audit a course, TedTalk, film screening, or listen to renowned author or global leader speak.
A caring culture. 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. Excellent health care benefits.
Discovery and fun. Historic sculptures, trails, museums.
Enviable resources. Free commuter programs, ridesharing incentives, discounts and more.
Schedule
Full‑time, Fixed‑Term – Hybrid Eligible
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Duties
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators.
Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
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.
Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
Lead or chair committees or task forces to address and resolve significant issues.
Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
Assist with analysis of data and preparation of manuscripts and scientific presentations.
Education & Experience (required)
Bachelor’s degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master’s degree preferred.
Knowledge, Skills and Abilities (required)
Excellent 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.
Demonstrated managerial experience.
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.
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.
Pay Range $124,521 to $153,615 per annum.
Benefits
Freedom to grow. Career development programs, tuition reimbursement, audit a course, TedTalk, film screening, or listen to renowned author or global leader speak.
A caring culture. 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. Excellent health care benefits.
Discovery and fun. Historic sculptures, trails, museums.
Enviable resources. Free commuter programs, ridesharing incentives, discounts and more.
Schedule
Full‑time, Fixed‑Term – Hybrid Eligible
#J-18808-Ljbffr