Live Support, Clinical Research Operations Specialist Ii (React)

2+ years

Not Disclosed

Remote, USA

10 Aug. 20, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Position: Clinical Research Operations Specialist II
Location: Remote (U.S.)
Organization: Stanford Center for Clinical Research (SCCR)

About Us:

The Stanford Center for Clinical Research (SCCR), part of the Stanford Department of Medicine, is dedicated to conducting and promoting innovative clinical research to improve human health. As we expand, we are seeking a Clinical Research Operations Specialist II to manage a large multi-site clinical trial focused on cardiovascular medicine.

Role Overview:

As a Clinical Research Operations Specialist II, you will play a crucial role in overseeing the management of virtual and multi-site clinical operations. You will be the primary contact for study sponsors and principal investigators, providing essential support and ensuring smooth operation across study sites.

Key Responsibilities:

Site Management:
- Provide live support to study sites for time-sensitive requests.
- Lead efforts in collecting participant safety data and review study Operations Manuals and Documents.
- Offer non-urgent support to study sites to enhance enrollment and safety.
Project Oversight:
- Manage subject recruitment and study enrollment, including developing strategies to attract and retain participants.
- Oversee data management, including organizing, collecting, reporting, and analyzing data.
- Develop and manage project schedules, targets, and accountabilities. Lead team meetings and handle minutes.
Staff Supervision and Training:
- Supervise, train, and mentor new staff or students. Assist with performance evaluations and project-related training.
Compliance and Audit:
- Audit operations to ensure regulatory compliance, including laboratory procedures. Implement corrective actions as needed.
- Monitor IRB submissions and respond to requests and queries.
- Ensure adherence to regulatory requirements, including FDA submissions and IRB renewals.
Budget and Financial Management:
- Develop and manage study budgets with staff and principal investigators. Track milestones and invoice sponsors as per study contracts.
Process Improvement:
- Recommend and implement improvements to policies and processes. Define and promote best practices.

Desired Qualifications:

Education:
- Bachelor’s degree in Clinical Research, Public Health, Business, or a related field.
Experience:
- 2 years of experience in project management and clinical research projects.
- Clinical research certification from ACRP, SOCRA, or Stanford's CROP is preferred.
Skills:
- Excellent communication and writing skills.
- Ability to create manuals and procedural documents.
- Strong leadership skills with experience in staff supervision and mentoring.
- Knowledge of clinical research study startup processes, including IRB submissions and site feasibility analyses.
- Experience with budget development and financial management.
Knowledge and Abilities:
- Strong interpersonal skills and proficiency in Microsoft Office and database applications.
- Familiarity with research protocols, HIPAA, FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
Certifications:
- Certification from the Society of Clinical Research Associates or Association of Clinical Research Professionals is preferred.
- Valid California Driver’s License may be required.

Physical Requirements:

Frequently: Stand, walk, bend, twist, squat, and use fine grasping.
Occasionally: Sit, reach above shoulders, perform desk-based tasks, lift objects up to 40 pounds.
Rarely: Kneel, crawl, climb, and lift objects over 40 pounds.

Working Conditions:

Possible exposure to hazardous materials, chemicals, or biological agents.
May require extended or unusual hours based on research needs.

Compensation:

Salary Range: $59,000 to $82,000 per annum, based on location and experience.
Benefits: Comprehensive benefits package including health care, retirement plans, and more. Details available on the Cardinal at Work website.

Why Stanford:

Stanford University is committed to revolutionizing the world through groundbreaking research and innovation. Our diverse and dedicated staff enjoy numerous benefits, including career development opportunities, a supportive work environment, and a balance between professional and personal life.

Apply today to be part of a team making significant impacts in clinical research!

For assistance with the application process or to request reasonable accommodations, please contact Stanford University Human Resources at stanfordelr@stanford.edu.

Stanford University is an equal employment opportunity and affirmative action employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.