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Clinical Operations Associate Jobs in Gaithersburg, MD

Saratoga Medical Center

Registered Nurse

Bethesda, MD · On-site

... clinical operations, and collaborating with healthcare professionals to ensure positive patient outcomes. Required Qualifications: * Bachelor's Degree, Associate Degree, or Diploma in Nursing from an ...

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Clinical Operations Associate information

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$12

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How much do clinical operations associate jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for clinical operations associate in Gaithersburg, MD is $28.36, according to ZipRecruiter salary data. Most workers in this role earn between $19.23 and $32.74 per hour, depending on experience, location, and employer.

What is a clinical operations associate?

A Clinical Operations Associate supports the planning, execution, and management of clinical trials to ensure compliance with regulatory guidelines and company protocols. They assist in coordinating trial logistics, managing documentation, and communicating with study sites and stakeholders. Their role helps ensure studies run efficiently, meet regulatory requirements, and generate reliable data for drug development and approvals.

What are the key skills and qualifications needed to thrive in the clinical operations associate position, and why are they important?

To thrive as a Clinical Operations Associate, you need a solid background in clinical research processes, project management, and regulatory compliance, often supported by a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and Good Clinical Practice (GCP) certification is highly valued. Attention to detail, strong organizational skills, and effective communication are important soft skills that help manage complex studies and collaborate with cross-functional teams. These abilities are crucial for ensuring that clinical trials run smoothly, meet regulatory standards, and maintain participant safety.

What are the typical responsibilities and team dynamics for a clinical operations associate?

As a Clinical Operations Associate, your typical responsibilities include coordinating study activities, maintaining trial documentation, supporting regulatory submissions, and ensuring adherence to protocols and timelines. You will often work as part of a multi-disciplinary team that includes clinical research coordinators, data managers, and study monitors, frequently communicating with internal and external stakeholders to keep the study on track. Collaboration and adaptability are key, as priorities can shift based on site needs or regulatory updates. This role offers valuable exposure to the operations side of clinical research and can serve as a springboard to more senior roles such as Clinical Project Manager or Clinical Research Associate.

What are the most commonly searched types of Clinical Operations jobs in Gaithersburg, MD?

The most popular types of Clinical Operations jobs in Gaithersburg, MD are:

What are popular job titles related to Clinical Operations Associate jobs in Gaithersburg, MD?

For Clinical Operations Associate jobs in Gaithersburg, MD, the most frequently searched job titles are:

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What cities near Gaithersburg, MD are hiring for Clinical Operations Associate jobs?

Cities near Gaithersburg, MD with the most Clinical Operations Associate job openings:

Clinical Operations Associate jobs near you
Infographic showing various Clinical Operations Associate job openings in Gaithersburg, MD as of August 2026, with employment types broken down into 89% Full Time, and 11% Part Time. Highlights an 94% In-person, and 6% Remote job distribution, with an average salary of $58,980 per year, or $28.4 per hour.

Clinical Regulatory Writer, Associate Director / Manager

AstraZeneca

Gaithersburg, MD • On-site

$133K - $199K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 17 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

22nd of 86 rated pharmaceutical

Job description

Job Title: Clinical Regulatory Writer, Associate Director / Manager

Location: Boston, MA OR Gaithesrburg, MD- Hybrid (3 days onsite)

Introduction to role:
Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca's core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals.

Accountabilities:

As a Clinical Regulatory Writer, Associate Director, you will:

  • Independently manage clinical regulatory writing activities across a complex portfolio of work.

  • Author the most complex clinical-regulatory documents within a program, ensuring regulatory, technical, and quality standards are met.

  • Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency.

  • Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead.

  • Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery.

  • Interpret complex data and information, condensing it into clear, concise messages that meet customer information requirements.

  • Demonstrate strategic thinking and review capabilities.

  • Collaborate proactively with other functions at the program level.

  • Support the development of Clinical Regulatory Writing Managers.

  • Drive continuous improvement and operational excellence from a communications leadership perspective.
    Essential Skills/Experience:

  • Education/Experience required:
    Associate Director level : BS Life Sciences degree or simiilar, 7+ yrs medical writing experience in pharmaceutical industry or CRO. Manager level: BS Life Sciences degree or simiilar, 2-7+ yrs medical writing experience in pharmaceutical industry or CRO

  • Ability to advise and lead communication projects.

  • Understand drug development and communication process from development, launch through life cycle management.

  • In-depth knowledge of the technical and regulatory requirements related to the role.

  • Ability to advise and lead communication projects.

  • Understand drug development and communication process from development, launch through life cycle management.

  • In-depth knowledge of the technical and regulatory requirements related to the role.

Desirable Skills/Experience:

  • Advanced degree in a scientific discipline (Ph.D.)

This is a Hybrid role - minimum requirment 3 days per week onsite


When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca is where innovation meets collaboration. We harness diverse knowledge to move with agility, working seamlessly across functions globally. Our team is empowered to make quick decisions, influencing drug development strategy at all levels. With a science-driven approach, we bring life-changing medicines to patients, constantly asking questions and trying new things. Your professional growth is passionately supported here, with opportunities to work on projects at all stages of development.

Ready to make an impact? Apply now and be part of our dynamic team!

The annual base pay (or hourly rate of compensation) for this position ranges from $133,042.40 - $199,563.60 USD Annual. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

10-Aug-2026

Closing Date

31-Aug-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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