Live Support, Clinical Research Operations Specialist Ii (React)

2+ years

Not Disclosed

Remote, USA

10 July 31, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 (Candidates must indicate their location on the resume)

Organization Overview: The Stanford Center for Clinical Research (SCCR) is a dynamic academic research organization within Stanford's Department of Medicine, committed to conducting innovative clinical research to improve human health.

Position Overview: SCCR seeks a Clinical Research Operations Specialist II to manage a large multi-site clinical trial in cardiovascular medicine. This role involves providing live support to study sites, managing virtual and multi-site operations, and serving as the main point of contact for the study sponsor and Principal Investigator (PI). Key responsibilities include supporting participant safety data collection, reviewing study operations manuals, and assisting study sites to optimize enrollment and safety.

Core Responsibilities:

Recruitment and Enrollment: Oversee participant recruitment and retention strategies for long-term clinical trials.
Data Management: Develop systems for organizing, collecting, and analyzing data, ensuring accurate reporting and monitoring.
Project Management: Create project schedules, set targets, lead team meetings, and prepare meeting minutes.
Team Supervision: Supervise, train, and mentor new staff or students, including performance evaluations and project instruction.
Compliance Auditing: Ensure compliance with regulations, audit operations, and implement corrective actions.
Collaboration: Work closely with PIs and study sponsors, monitor serious adverse events, and address study queries.
Policy Improvement: Recommend and implement improvements to processes and best practices.
Budget Management: Collaborate with staff and PIs to develop study budgets, track milestones, and manage sponsor invoicing.
Regulatory Compliance: Ensure ongoing compliance with regulations and assist with Institutional Review Board (IRB) submissions.

Desired Qualifications:

Certifications: Clinical research certification from ACRP, SOCRA, or Stanford's CROP.
Education: Bachelor’s degree in Clinical Research, Public Health, Business, or related field.
Experience: 2+ years in project management and clinical research, with skills in writing manuals and procedural documents.
Communication: Excellent verbal and written communication skills, with experience in public speaking and stakeholder presentations.
Knowledge: Familiarity with Clinical Research Study Startup processes, including IRB submissions and site feasibility analyses.
Leadership: Strong leadership skills with a track record of mentoring and policy improvement.

Required Qualifications:

Education & Experience: Bachelor’s degree in a related field and two years of clinical research experience, or an equivalent combination of education and relevant experience.
Skills: Strong interpersonal skills, proficiency in Microsoft Office, and familiarity with research protocols and regulatory bodies such as HIPAA, FDA, and IRB.
Medical Terminology: Knowledge of medical terminology is required.

Certifications & Licenses:

Preferred: Certification from the Society of Clinical Research Associates or Association of Clinical Research Professionals.
Driver’s License: May require a valid California Driver’s License.

Physical Requirements:

Frequent standing, walking, twisting, bending, and fine grasping.
Occasional sitting, reaching above shoulders, desk-based tasks, and lifting objects up to 40 pounds.
Rarely kneeling, crawling, climbing ladders, or lifting heavier objects.

Working Conditions:

Potential exposure to hazardous materials, chemicals, blood, body fluids, or contagious diseases.
May require extended or unusual work hours based on research needs.

Working Standards:

Interpersonal Skills: Ability to work well with Stanford colleagues and external organizations.
Safety Commitment: Adherence to safety standards and practices.
Policy Compliance: Compliance with all University policies and procedures.

Compensation: This position offers a salary range of $59,000 to $82,000 per annum, depending on factors such as position scope, candidate qualifications, and location. Stanford University provides a comprehensive benefits package, details of which can be found on the Cardinal at Work website.

Why Stanford? Stanford University offers a unique work environment, fostering career growth and work-life balance. Benefits include career development programs, tuition reimbursement, health care benefits, fitness classes, and more. Join us to contribute to world-changing research and innovation.

Equal Opportunity Employment: Stanford University is committed to providing equal employment opportunities to all qualified applicants, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Application Process: Applicants requiring reasonable accommodations should contact Stanford University Human Resources at stanfordelr@stanford.edu. For general inquiries, please submit a contact form.