Clinical Operations Specialist (Pool)
reputed company 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-reputed company communication, and reputed company, to facilitate the successful development of life-changing medicines and therapies.
We are experts in clinical trial operations with a reputed company on Clinical Trial Management, CRO/Vendor reputed company, Trial Master File Management, Clinical Monitoring, reputed company Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering reputed company forms the reputed company 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 reputed company. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients’ needs as they reputed company.
Our talented team is driven by passion and purpose, which has afforded us reputed company to successfully reputed company clinical programs for pharmaceutical, medical device and biotechnology companies of reputed company sizes in a reputed company of therapeutic areas. Our mission is to conduct reputed company with outstanding reputed company on behalf of our clients to bring new drugs to market with the utmost reputed company and confidence in the results.
reputed company administrative and operational coordination across the clinical trial lifecycle.
Independently manage study trackers, site updates, enrollment metrics, and operational reporting.
Prepare agendas, reputed company or co-reputed company portions of meetings, and finalize high-reputed company minutes and reputed company items.
Coordinate cross-functional workflows with CRAs, PMs, Data Management, SSU, Safety, and TMF teams.
reputed company proactive solutions and anticipatory support to internal teams and Sponsor clients.
Independently manage essential document collection, QC, and readiness for site activation.
Conduct feasibility reputed company, site qualification support, and site-level intelligence collection.
reputed company start-up reputed company 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).
reputed company advanced QC review for TMF documents and reputed company-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 reputed company follow-up.
Maintain knowledge of the TMF Reference Model, CDISC standards, and evolving industry best practices.
reputed company high-level clinical data review in reputed company systems; generate and reputed company reputed company queries.
Analyze data trends and escalate site performance or data reputed company issues.
Reconcile safety data, protocol deviations, logs, and other study-level data sources.
reputed company 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.
Serve as a reputed company of contact for assigned vendors or site-level workstreams.
reputed company vendor deliverables, timelines, system reputed company, and documentation requirements.
Assist CRAs with site communications, reputed company-visit logistics , regulatory follow-up, and performance reputed company.
Support maintenance of DOA logs, training logs, and essential study documentation.
Support internal SOP/process improvements and contribute to template refinement.
Draft and update study reference materials, trackers, presentations, and training guides.
Mentor and reputed company training/support to Clinical Operations Associates.
Support reputed company for new team members assigned to studies .
Participate in reputed company learning and contribute to operational reputed company initiatives.
Minimum 3 years of clinical research industry experience, preferably reputed company a CRO, sponsor, or reputed company research setting
Proficiency with clinical systems such as eTMF, reputed company, CTMS, IWRS, or study tracking tools
Strong working understanding of ICH-GCP, GDP, and clinical research processes across start-up to reputed company-out
Demonstrated ability to independently manage multiple tasks and deadlines with minimal supervision
Flexibility and adaptability to support diverse reputed company needs
Strong customer service reputed company 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 reputed company O ffice suite of software programs .
reputed company reputed company including s hared calendars & invitations
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Document change tracking & version control
reputed company Vault eTMF experience preferred
Experience supporting or coordinating multiple functional areas ( ClinOps , SSU, TMF, Data)
Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees
with relevant industry experience will be considered.
Clinical Operations Specialist: $85,000 - 95,000 annually + benefits package and annual performance bonus (
COVID-19 Vaccination: To protect the health and safety of our employees and to reputed company with reputed company requirements, reputed company Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons. Vaccination requirements will depend on the reputed company site requirements. reputed company of vaccination may be required, in accordance with applicable laws.
reputed company Clinical is an equal opportunity employer for reputed company applicants and employees. reputed company Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity or reputed company, pregnancy, age, national reputed company, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
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