Clinical Operations Specialist (Pool)

vanguardclinical; California (MO); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Vanguard Clinical, Inc. in San Diego, CA, is seeking a Clinical Operations Specialist (COS) to drive key operational activities across Clinical Operations, SSU, TMF, Data Management, and Vendor Oversight.

This experienced professional will support site activation, study startup timelines, and cross-functional coordination. The COS will mentor Clinical Operations Associates, contribute to process improvements, and serve as a core operational contributor on assigned studies, with flexibility to

Qualifications

• Minimum 3 years of clinical research experience, preferably in CRO, sponsor, or academic settings.
• Proficiency with clinical systems such as eTMF, EDC, CTMS, IWRS, or study tracking tools.
• Strong understanding of ICH-GCP, GDP, and clinical research processes from start-up to close-out.
• Ability to independently manage multiple tasks and deadlines with minimal supervision.
• Flexible and adaptable to support diverse client needs with a customer-service mindset.

Responsibilities

• Lead cross-functional coordination across the clinical trial lifecycle.
• Manage study trackers, site updates, enrollment metrics, and operational reporting.
• Coordinate with CRAs, PMs, Data Management, SSU, Safety, and TMF teams.
• Support SSU activities: document QC, site activation readiness, and ICF customization.
• Support TMF management with QC, filing, and audit readiness.
• Mentor Clinical Operations Associates and support onboarding.
• Support onboarding for new team members and contribute to continuous improvement initiatives.

Skills

Clinical research experience

CRO/Sponsor oversight

eTMF/EDC/CTMS/IWRS familiarity

ICH-GCP/GDP knowledge

Cross-functional coordination

Tools

eTMF

EDC

CTMS

IWRS

Study tracking tools

Job description

Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA, USA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-active communication, and integrity, to facilitate the successful development of life-changing medicines and therapies.

We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a “white glove service” approach to clinical trials. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients’ needs as they evolve.

Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results.

Position Overview:

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.

This role expands on the foundational skills of the Clinical Operations Associate by taking on greater autonomy, ownership of study workstreams, deeper client-facing responsibilities, advanced documentation quality control, and cross-functional coordination.

The COS serves as a core operational contributor on assigned studies and may support internal process development, Clinical Operations Associate mentorship, and continuous improvement initiatives. This role is flexible and adaptable, allowing assignment into multiple functional areas depending on client and organizational needs (ClinOps, SSU, TMF, Data, Site Support, or hybrid functions).

Essential Duties & Responsibilities:

Clinical Operations Support

• 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.

Study Start-Up (SSU) Support

• 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.
• Review and support customization of site-specific and country-specific ICFs.
• Assist sites with IRB/EC submissions, regulatory queries, and document completeness.
• Contribute to contract/budget negotiation coordination (non-financial aspects).

TMF Management

• 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.
• Maintain knowledge of the TMF Reference Model, CDISC standards, and evolving industry best practices.

Data Management / Site Data Quality Support

• Perform high-level clinical data review in EDC systems; generate and track complex queries.
• Analyze data trends and escalat[e] site performance or data quality issues.
• Reconcile safety data, protocol deviations, logs, and other study-level data sources.
• Provide training/support to sites on data entry, documentation requirements, and system navigation.
• Collaborate with Sponsor Data Management and Clinical Science teams on data review packages.

Vendor & Site Management Support

• Serve as a point of contact for assigned vendors or site-level workstreams.
• Track vendor deliverables, timelines, system access, and documentation requirements.
• Assist CRAs with site communications, pre-visit logistics, regulatory follow-up, and performance oversight.
• Support maintenance of DOA logs, training logs, and essential study documentation.

Cross-Functional Study Support

• Support internal SOP/process improvements and contribute to template refinement.
• Draft and update study reference materials, trackers, presentations, and training guides.
• Mentor and provide training/support to Clinical Operations Associates.
• Support onboarding for new team members assigned to studies.
• Participate in continuous learning and contribute to operational excellence initiatives.

Experience & Skills:

• 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