The Clinical Operations Specialist (COS) is an experienced, cross-functional clinical research professional responsible for supporting and driving key operational activities across Clinical Operations, Study Start-Up (SSU), Trial Master File (TMF) Management, Data Management, Vendor Oversight, Site Support, and broader study execution.
Lead administrative and operational coordination across the clinical trial lifecycle.
Independently manage study trackers, site updates, enrollment metrics, and operational reporting.
Prepare agendas, lead or co-lead portions of meetings, and finalize high-quality minutes and action items.
Coordinate cross-functional workflows with CRAs, PMs, Data Management, SSU, Safety, and TMF teams.
Provide proactive solutions and anticipatory support to internal teams and Sponsor clients.
Independently manage essential document collection, QC, and readiness for site activation.
Conduct feasibility outreach, site qualification support, and site-level intelligence collection.
Lead start-up timeline tracking and drive accountability with sites and vendors.
Perform advanced QC review for TMF documents and root-cause identification for recurring issues.
Independently manage TMF filing, metadata application, and cross-checking for document dependencies.
Support audit/inspection readiness, including TMF remediation, reporting, and corrective action follow-up.
Perform high-level clinical data review in EDC systems; generate and track complex queries.

Requirements

Minimum 3 years of clinical research industry experience, preferably within a CRO, sponsor, or academic research setting
Proficiency with clinical systems such as eTMF, EDC, CTMS, IWRS, or study tracking tools
Strong working understanding of ICH-GCP, GDP, and clinical research processes across start-up to close-out
Demonstrated ability to independently manage multiple tasks and deadlines with minimal supervision
Flexibility and adaptability to support diverse client needs
Strong customer service mindset with a solutions-oriented approach
Demonstrated strengths in planning, organization, time management, problem solving, and attention to detail
Excellent oral and written communications and presentation skills; ability to communicate effectively with vendors and clients
Detailed knowledge of Microsoft Office suite of software programs.

Benefits

health insurance
401k retirement plan
paid days off
annual performance bonus

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchstudy trackingdata managementTMF managementQC reviewenrollment metricsfeasibility outreachsite qualificationclinical data reviewquery generation

Soft Skills

planningorganizationtime managementproblem solvingattention to detailcustomer serviceflexibilityadaptabilitycommunicationleadership