Clinical Research Operations Assessment Specialist

Summary

Join Vitalief as a Clinical Research Operations Assessment Specialist for a short-term, remote contract (3 months, possible extension) supporting a multi-location community hospital system. Collaborate with the Lead Consultant and team to assess Non-Oncology clinical research operations, focusing on technology, organization, process, people, and finances. Conduct interviews with stakeholders, document findings, and contribute to recommendations for improvement. The ideal candidate possesses 7+ years of clinical research experience, a life sciences degree (or equivalent), and strong analytical and communication skills. The role involves working remotely (EST zone) with one early-stage on-site visit. Market-competitive pay is offered.

Requirements

• Minimum of 7 years’ experience in clinical research, ideally with exposure to site operations or trial management in a hospital setting
• Bachelor’s degree in life sciences, healthcare, or related discipline (or equivalent combination of education and experience)
• Familiarity with all functional areas within clinical research including: Study Start-Up & Regulatory Affairs (IRB/ethics submissions; Contract and budget negotiation, Feasibility assessments); Patient Recruitment & Enrollment; Clinical Operations / Study Coordination; Principal Investigator & Sub-Investigator Oversight; Data Management & Quality Assurance; Pharmacy / Investigational Product (IP) Management; and Laboratory Services
• Strong interpersonal skills and the ability to conduct effective interviews with diverse stakeholders
• Proficient in capturing and summarizing qualitative information clearly and concisely
• Detail-oriented with strong organizational and follow-up skills
• Ability to work effectively as part of a collaborative consulting team
• Strong analytical skills with the ability to quantify operational risks/deficiencies and financial/operational benefits
• Highly driven, results-oriented, and thrive in fast-paced, entrepreneurial environments

Responsibilities

• Function as an integral member of the Vitalief consulting team to deliver a comprehensive current-state operational assessment across Technology, Organization, Process, People, and Finances, with a strong focus on Non-Oncology programs and cross-system communication effectiveness
• Collaborate with the Vitalief team to design effective interview templates and assessment tools
• Conduct structured interviews with clinical research staff and other key stakeholders across all functional areas of clinical trials to gather current-state information
• Accurately document and summarize findings for review by the Lead Consultant and project team
• Assist in organizing and synthesizing interview results to identify potential process gaps and improvement opportunities
• Support the preparation of materials, reports, and presentations for the client
• Collaborate closely with the Lead Consultant and team members to ensure timely completion of deliverables

Preferred Qualifications

• Experience in both Oncology and Non-Oncology clinical research operations
• Familiarity with common research operations technologies (e.g., CTMS, EMR integration)
• Prior experience participating in operational assessments or process improvement initiatives

Benefits

• Pay Rate: Market competitive (depends on experience level)
• Location: Remote (EST zone work hours) with 1 early-stage on-site visit (expenses covered)