Live Support, Clinical Research Operations Specialist Ii (React)

2+ years

Not Disclosed

Remote, USA

10 Sept. 17, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Operations Specialist II
Location: Remote
Department: Stanford Center for Clinical Research (SCCR), Department of Medicine
Salary Range: $59,000 - $82,000 per annum (based on location)

About Us:
The Stanford Center for Clinical Research (SCCR) is a dynamic academic research organization within the Stanford Department of Medicine, dedicated to conducting and promoting high-impact, innovative clinical research to advance human health.

Role Overview:
We are seeking a Clinical Research Operations Specialist II to lead and manage a large multi-site clinical trial in cardiovascular medicine. In this role, you will be the primary contact for study sites, the study sponsor, and the principal investigator (PI), providing essential support and managing both virtual and in-person site operations.

Key Responsibilities:

Site Management: Provide live support to study sites for time-sensitive requests and manage overall site operations.
Participant Recruitment and Retention: Oversee recruitment and enrollment goals, and develop strategies to engage and retain participants in long-term trials.
Data Management: Develop and manage systems for data collection, organization, and reporting. Analyze and interpret data as needed.
Project Oversight: Create project schedules, targets, and accountabilities. Lead team meetings and prepare/approve meeting minutes.
Staff Supervision: Supervise, train, and mentor new staff or students. Handle hiring and performance evaluations as required.
Compliance and Audits: Audit operations to ensure regulatory compliance, including laboratory procedures. Monitor and respond to Institutional Review Board (IRB) submissions and queries.
Collaboration: Work closely with principal investigators and study sponsors to monitor and report serious adverse events and resolve study queries.
Process Improvement: Recommend and implement improvements to policies and processes. Define and promote best practices.
Budget Management: Develop study budgets, track milestones, and manage invoicing for sponsors according to study contracts.
Regulatory Compliance: Ensure adherence to regulatory requirements, including Investigational New Drug (IND) applications and IRB renewals.

Desired Qualifications:

Education: Bachelor’s degree in Clinical Research, Public Health, Business, or a related field.
Experience: 2 years in project management and clinical research, with a demonstrated ability to write manuals, present to stakeholders, and develop budgets.
Certifications: Clinical research certification from ACRP, SOCRA, or Stanford’s CROP is preferred.
Skills: Excellent communication, writing, and leadership skills. Proficiency in Microsoft Office and database applications. Knowledge of clinical research protocols, HIPAA, FDA regulations, and Good Clinical Practices.

Required Qualifications:

Education: Bachelor’s degree in a related field and two years of clinical research experience, or equivalent combination of education and relevant experience.
Knowledge and Skills: Strong interpersonal skills, proficiency in data management, and familiarity with medical terminology. Ability to supervise and mentor staff.

Physical Requirements:

Frequent standing, walking, and use of fine motor skills. Occasionally sit, perform desk-based tasks, and lift up to 40 pounds. Rarely engage in strenuous physical activities.

Working Conditions:

Potential exposure to hazardous materials and chemicals, and risk of exposure to contagious diseases. May require extended or unusual hours based on research needs.

Working Standards:

Demonstrate commitment to safety, work well with colleagues and external organizations, and adhere to university policies and procedures.

Why Stanford?
Stanford University offers a supportive and enriching work environment with opportunities for career development, a caring culture, excellent health and wellness benefits, and access to a range of unique resources and activities.

Application Process:
To apply, submit your application and ensure all information is accurate. Stanford University is an equal opportunity employer and provides reasonable accommodations for applicants with disabilities. For more details, visit our Cardinal at Work website or contact Stanford University Human Resources.

Contact Information:
For accommodation requests, contact Stanford University Human Resources at stanfordelr@stanford.edu. For other inquiries, please submit a contact form.

Equal Opportunity Statement:
Stanford University is committed to providing equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

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Live Support, Clinical Research Operations Specialist Ii (React)

Job Description

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