Clinical Operations Specialist

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee administrative and operational coordination throughout the clinical trial lifecycle.

• Take charge of study trackers, site updates, enrollment metrics, and operational reporting independently.

• Organize meeting agendas, lead or co-lead segments of meetings, and produce comprehensive minutes and action items.

• Facilitate cross-functional workflows in collaboration with CRAs, PMs, Data Management, SSU, Safety, and TMF teams.

• Offer proactive solutions and anticipatory support to internal teams and Sponsor clients.

• Independently handle the collection, quality control, and readiness of essential documents for site activation.

• Conduct feasibility outreach, support site qualification, and gather site-level intelligence.

• Execute advanced quality control reviews for TMF documents and identify root causes for recurring issues.

• Conduct high-level clinical data reviews within EDC systems and generate as well as track complex queries.

• Act as a point of contact for assigned vendors or site-level workstreams.

• Assist in the enhancement of internal SOPs/processes and contribute to the refinement of templates.

⛳️ Requirements

• At least 3 years of experience in the clinical research industry, ideally within a CRO, sponsor, or academic research environment.

• Proficient in clinical systems such as eTMF, EDC, CTMS, IWRS, or study tracking tools.

• Solid understanding of ICH-GCP, GDP, and clinical research processes from start-up to close-out.

• Proven ability to independently manage multiple tasks and meet deadlines with minimal supervision.

• Ability to adapt and be flexible to cater to diverse client needs.

• Strong customer service orientation with a focus on solutions.

• Demonstrated capabilities in planning, organization, time management, problem-solving, and attention to detail.

• Exceptional oral and written communication skills, with the ability to effectively engage with vendors and clients.

• Thorough knowledge of Microsoft Office suite software programs.

🏝️ Benefits

• Health insurance

• 401k retirement plan

• Paid days off

• Annual performance bonus