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Study Management Associate Jobs in Tustin, CA (NOW HIRING)

Heluna Health

Research Associate

Santa Ana, CA · On-site

$28.82 - $36.25/hr

The Research Associate will join the team under the general oversight of the Orange County TB ... Collect and manage study specific biological specimens (e.g., blood, sputum, and face mask samples ...

Heluna Health

Research Associate

Santa Ana, CA · On-site

$59.95 - $75.40/hr

The Research Associate will join the team under the general oversight of the Orange County TB ... Collect and manage study specific biological specimens (e.g., blood, sputum, and face mask samples ...

Heluna Health

Research Associate

Santa Ana, CA · On-site

$28.82 - $36.25/hr

The Research Associate will join the team under the general oversight of the Orange County TB ... Collect and manage study specific biological specimens (e.g., blood, sputum, and face mask samples ...

RICK

Be Seen First

Civil Engineer Project Manager Associate

Riverside, CA · On-site

... management and supervisory skills, and be adept in establishing and maintaining strong and positive ... Candidate's technical experience must include the following: preliminary engineering design studies ...

CellCarta

Associate Project Manager

Lake Forest, CA · On-site

$65 - $81/hr

Associate Project Manager As an Associate Project Manager (APM) at the CellCarta Lake Forest site ... Study Execution & Lifecycle Management: Partner with Senior PMs to plan, coordinate, and execute ...

CellCarta

Associate Project Manager

Lake Forest, CA · On-site

$65K - $81K/yr

Associate Project Manager As an Associate Project Manager (APM) at the CellCarta Lake Forest site ... Study Execution & Lifecycle Management: Partner with Senior PMs to plan, coordinate, and execute ...

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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.

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

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Study Management Associate jobs near you
Infographic showing various Study Management Associate job openings in Tustin, CA as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 90% Physical, 2% Hybrid, and 8% Remote job distribution.

Clinical Research Associate - Multiple Levels Available

Glaukos

San Clemente, CA • On-site

Full-time

Posted 19 days ago

Job description


The Clinical Research Associate (CRA) is responsible for establishing and maintaining the Study Master File, tracks critical trial information, and supports Regional Clinical Research Associates under the guidance of a Clinical leadership
Responsibilities
How will you make an impact?
Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level.
What will you do?
CLINICAL SITE MONITORING
  • Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits
  • Assist with selection of potential investigators
  • Conduct initial and ongoing site training throughout the course of the study Verify informed consent process is properly followed
  • Evaluate investigator compliance with the study protocol and applicable regulations
  • Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries
  • Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed
  • Verify and reconcile site's essential documents against the trial master file as required
  • Oversee and conduct monitoring activities, including remote monitoring when applicable
  • Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study

CLINICAL SITE MANAGEMENT
  • Assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study
  • Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance
  • Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity
  • Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability
  • Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites.
  • Create and maintain appropriate documentation (e.g., visit reports/letters)
  • Works independently with seldom supervision
  • Mentor/train new CRAs
  • Conduct peer to peer review visits
  • Provide FDA inspection support
  • Maintain strong productive relationships with study investigators, site staff, and study management personnel, including assessment and resolution of existing relationship issues
  • Participate in the development of source document templates, CRFs, CRF completion guidelines, monitoring plans, etc.
  • Executes department projects

How will you get here?
  • Clinical coordinating experience in ophthalmology required
  • Degree in biological science, nursing, or other related discipline preferred, or direct work experience
  • Experience medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels
  • Knowledge and understanding of Good Clinical Practices (ICH E6 R2)
  • Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies
  • Must have proficient computer skills and experience with Microsoft Office
  • Must be willing and able to travel approximately 75-80%, including overnight, domestic and international
  • Must have Self-directed behavior
  • Ideally will be located in Western US

#GKOSUS

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