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Study Management Associate Jobs (NOW HIRING)

Eurofins

Specimen Management Associate

Lancaster, PA · On-site

... clinical studies, as well as having an emerging global presence in Contract Development and ... The Sample Management Associate (SMA) is primarily responsible for processing incoming specimens ...

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Study Management Associate information

What are the key skills and qualifications needed to thrive as a Study Management Associate, and why are they important?

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 are the typical responsibilities of a Study Management Associate in a clinical research team?

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 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 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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Study Management Associate jobs near you
Infographic showing various Study Management Associate job openings in the United States as of May 2026, with employment types broken down into 95% Full Time, 4% Part Time, and 1% Contract. Highlights an 93% Physical, 5% Hybrid, and 2% Remote job distribution.
Senior Clinical Research Associate - Bilingual

Senior Clinical Research Associate - Bilingual

atricure

Mason, OH • On-site

Other

Posted 13 days ago

Job description

POSITION SUMMARY:

The Senior Clinical Research Associate (Sr. CRA) at AtriCure plays a vital role in the Clinical Affairs department, independently managing and overseeing site management and/or monitoring activities during clinical trial execution. This position requires a high level of autonomy and leadership, providing guidance to junior team members and ensuring compliance with regulatory standards and protocols. The Sr. CRA is instrumental in maintaining the integrity of clinical data and adapting to evolving study needs.

ESSENTIAL FUNCTIONS OF THE POSITION:

Site Management

  • Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel.
  • Conduct Site Qualification, Initiation, Interim and Close-Out training visits.
  • Facilitate required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes.

Site Communications

  • Act as the primary point of contact for site communications and inquiries.
  • Liaise with clinical study management, field personnel, and CROs, addressing moderately complex protocol or study related issues as necessary.

Compliance

  • Ensure clinical study sites adhere to assigned protocols and regulatory standards, independently reviewing individual site compliance and addressing issues with study management.

Data Management

  • Review and analyze data for accuracy and completeness.
  • Lead the creation, management, and resolution of data queries for assigned sites
  • Support development of data cleaning reports and metrics in collaboration with data and operations management teams.

Monitoring

  • Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements.
  • Assist in reviewing peer interim monitoring visit (IMV) reports.

Safety

  • Manage the processing of product complaints and adverse events, collaborating with safety specialists to gather materials for CEC meetings.

Study Management

  • Draft study-related materials, such as patient brochures and recruitment tools.
  • Support the coordination of activities with study-specific committees, vendor services, and core labs.

Leadership and Development

  • Provide mentorship and guidance to junior team members, fostering a collaborative environment.
  • Engage in continuous professional development and contribute to strategic project management activities.

Other Duties

  • Ensure appropriate translations for study documents and engage in global process improvement initiatives.
  • Mentor less experienced clinical team members and participate in core team activities.
  • Contribute to departmental SOPs and work instructions, driving revisions as necessary.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable work performance
  • Ability to work under fast-paced conditions
  • Ability to make decisions and use good judgement
  • Ability to prioritize various duties and multitask as required
  • Ability to successfully work with others
  • Additional duties as assigned

BASIC QUALIFICATIONS:

  • Bachelor’s degree with a minimum of 5 years of clinical research experience.
  • Must be bilingual in French and English.
  • Strong leadership, organizational, and communication skills with the ability to work independently and as part of a team.
  • Proficiency in Microsoft Office Suite and familiarity with clinical data management systems.
  • Willingness to travel between 10-75% of the time.

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as needed
  • Ability to occasionally bend and push/pull as needed

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