Clinical Research Operations Assessment Specialist
Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. We bring deep clinical research expertise together with practical, results-driven consulting to help organizations operate more efficiently and achieve sustainable growth. The Role
We are seeking an experienced Clinical Research Operations Assessment Specialist to support a short-term operational assessment engagement for a multi-location community hospital system. This role will work closely with the Lead Consultant (Subject Matter Expert) and the Vitalief delivery team to gather insights, summarize findings, and contribute to recommendations for enhancing Non-Oncology clinical research operations and cross-system communication. The ideal candidate will be comfortable engaging with stakeholders, documenting key observations, and synthesizing input into clear summaries that help drive the overall assessment process. Engagement Details
- Work Hours: 40 hours per week
- Contract Duration: 3 months (possible extension)
- Pay Rate: Market competitive (depends on experience level)
- Location: Remote (EST zone work hours) with 1 early-stage on-site visit (expenses covered)
- 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.
- 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.
- 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.
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