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Study Management Associate Jobs in San Ramon, CA

Primary Function of Position The Clinical Research Associate will play a key role in proactively ... The candidate will be required to work closely with clinical study managers, clinical trial ...

Primary Function of Position The Clinical Research Associate will play a key role in proactively ... The candidate will be required to work closely with clinical study managers, clinical trial ...

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Study Management Associate information

What is a study management associate?

A Study Management Associate is a professional who supports the planning, coordination, and execution of clinical trials or research studies. They typically assist study managers or project leads by handling administrative tasks, maintaining study documentation, and ensuring compliance with regulatory guidelines. Their responsibilities may include scheduling meetings, tracking study progress, managing study supplies, and liaising with study sites or vendors. This role is essential for keeping research studies organized and running efficiently.

What are the typical responsibilities of a study management associate?

As a Study Management Associate, you will play a key role in supporting clinical trials by coordinating study logistics, maintaining essential documentation, and ensuring compliance with regulatory guidelines. Your daily tasks may include organizing meetings, tracking study progress, preparing reports, and liaising with clinical sites and vendors. You will work closely with study managers, clinical research associates, and data management teams to ensure trials run smoothly and efficiently. This collaborative environment provides valuable exposure to various aspects of clinical research and can serve as a strong foundation for career advancement within the industry.

What are the key skills and qualifications needed to thrive as a study management associate?

To thrive as a Study Management Associate, you need strong organizational skills, attention to detail, and a background in life sciences or clinical research, often supported by a relevant bachelor's degree. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) tools, and knowledge of regulatory guidelines such as GCP are typically required. Effective communication, time management, and problem-solving abilities help facilitate collaboration among cross-functional teams and ensure smooth study execution. These skills are crucial for maintaining the quality, compliance, and efficiency of clinical studies.

What is the difference between Study Management Associate vs Clinical Research Coordinator?

AspectStudy Management AssociateClinical Research Coordinator
Required CredentialsBachelor's degree, relevant certifications often preferredBachelor's degree, often with certifications like CCRP
Work EnvironmentPharmaceutical companies, CROs, research institutionsHospitals, clinics, research sites
Employer & Industry UsageUsed in industry-sponsored trials and clinical research firmsCommon in academic and hospital-based studies
Search & Comparison IntentHigh overlap in job duties and qualificationsSimilar roles with some operational differences

The Study Management Associate and Clinical Research Coordinator roles share many similarities, including required education and work environments. However, the Study Management Associate typically focuses on supporting study operations within industry settings, while the Clinical Research Coordinator often manages patient interactions and site activities in clinical settings. Both roles are essential in advancing clinical research but differ slightly in scope and daily responsibilities.

What are popular job titles related to Study Management Associate jobs in San Ramon, CA?

For Study Management Associate jobs in San Ramon, CA, the most frequently searched job titles are:

What job categories do people searching Study Management Associate jobs in San Ramon, CA look for?

The top searched job categories for Study Management Associate jobs in San Ramon, CA are:

What cities near San Ramon, CA are hiring for Study Management Associate jobs?

Cities near San Ramon, CA with the most Study Management Associate job openings:

Clinical Trial Associate - Late Phase

San Francisco, CA • On-site

$39.50 - $54/hr

Other

Posted 5 days ago


Job description


  • Provide operational and administrative support for Latigo-sponsored clinical trials

  • Support clinical operations across study start-up, maintenance, and close-out activities

  • Review eTMF index/structure and perform eTMF set-up activities

  • Collect and track essential documents, site contact information, regulatory documents, and training documentation

  • Oversee maintenance of the electronic Trial Master File and perform interim quality checks

  • Organize and maintain internal study SharePoint sites

  • Maintain study trackers, contact lists, meeting action item logs, training trackers, vendor trackers, and other study management tools

  • Schedule study meetings, prepare agendas, draft minutes, distribute follow-up items, and track action items

  • Support clinical trial systems and portals, including access requests, user tracking, document uploads, and issue follow-up

  • Review and reconcile study documents, site correspondence, monitoring documentation, safety-related documentation, and vendor deliverables

  • Coordinate logistics for investigator meetings, study team meetings, site training, vendor meetings, and other clinical trial activities

  • Track clinical trial milestones, deliverables, risks, issues, and decisions; escalated delays or issues

  • Support backroom operations during regulatory inspections

  • Track invoices, budgets, contracts, and work orders

  • Maintain awareness of applicable clinical research regulations, ICH-GCP guidelines, study protocols, SOPs, and project-specific plans

  • Perform other clinical operations duties as assigned


Requirements

  • Bachelor’s degree or equivalent, preferably in a scientific discipline or health-related field

  • Minimum of 2 years of relevant industry experience

  • Working knowledge of clinical trial conduct, study start-up, maintenance, and close-out activities

  • Familiarity with ICH-GCP, CFR, and other applicable regulatory requirements for clinical trial conduct

  • Experience supporting Trial Master File activities preferred

  • Strong organizational skills and attention to detail

  • Ability to manage multiple priorities in a fast-paced, cross-functional environment

  • Excellent written and verbal communication skills

  • Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams

  • Ability to collaborate effectively with internal study teams and vendors

  • Demonstrated ability to follow established processes, identify issues, elevate appropriately, and support timely resolution of action items

  • Effective collaboration across time zones and with internal and external stakeholders


Core Competencies

Demonstrates expertise in clinical trial operations, including study start-up, maintenance, and close-out activities, while ensuring compliance with ICH-GCP guidelines and regulatory requirements. Proficient in managing documentation, tracking milestones, and facilitating effective communication among study teams and vendors.


Highest-signal resume keywords

  • Clinical Trial Operations

  • ICH-GCP Compliance

  • Trial Master File Management

  • Microsoft Office Proficiency

  • Organizational Skills


ATS Optimization Keywords
Hard Skills

  • Clinical Trial Conduct

  • Study Start-Up Activities

  • Study Maintenance

  • Study Close-Out Activities

  • ETMF Set-Up

  • Document Tracking

  • Regulatory Document Review

  • Quality Checks

  • Budget Tracking

  • Invoice Management


Soft Skills

  • Attention to Detail

  • Effective Collaboration

  • Strong Communication Skills

  • Ability to Manage Multiple Priorities

  • Problem-Solving


Industry Keywords

  • Clinical Research Regulations

  • CFR Compliance

  • SOPs

  • Study Protocols

  • Regulatory Inspections


Tools & Technologies

  • SharePoint

  • Clinical Trial Systems

  • Microsoft Word

  • Microsoft Excel

  • Microsoft PowerPoint

  • Microsoft Outlook

  • Microsoft Teams

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