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Clinical Study Associate Jobs in Reston, VA (NOW HIRING)

MacroGenics, Inc.

Sr. TMF Manager

Rockville, MD · On-site

$34.25 - $46.75/hr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Maintain effective communication with clinical study teams, CRO staff and TMF vendor personnel throughout study start-up, maintenance and close out. * Propose, drive and support process improvement ...

Smithers Group

Study Coordinator

Gaithersburg, MD · Hybrid

$60K - $75K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... clinical services for all phases of drug development. PDS works with customers to develop and ... Study Coordinator I * Minimum of an associate degree in Biological Sciences or equivalent ...

Emmes

Senior Biostatistician

Rockville, MD · On-site +1

  • Medical

  • Retirement

May supervise Biostatisticians, Associate Biostatisticians and SAS programmers (all levels) and direct their work on clinical research studies. * Leads the project team's development of study ...

Emmes

Senior Biostatistician

Rockville, MD · On-site

$90 - $120/hr

  • Medical

  • Retirement

May supervise Biostatisticians, Associate Biostatisticians and SAS programmers (all levels) and direct their work on clinical research studies. * Leads the project team's development of study ...

Emmes

Senior Biostatistician

Rockville, MD · On-site +1

  • Medical

  • Retirement

May supervise Biostatisticians, Associate Biostatisticians and SAS programmers (all levels) and direct their work on clinical research studies. * Leads the project team's development of study ...

Abbott

Clinical Associate

Arlington, VA · On-site

  • Medical

  • Retirement

As a Clinical Associate on the U.S. Abbott EP team, you will provide clinical and technical support ... Participating in clinical studies/data collection; * Troubleshooting; and, * Leading/supporting new ...

IQVIA

MedTech Site Manager 1

Washington, DC

$74K - $124K/yr

Responsible for management of investigator site and Clinical Research Associate (CRA) activities for assigned studies. The In-House CRA will execute Clinical Affairs functions in accordance with Good ...

New

IQVIA

MedTech Site Manager 1

Washington, DC

$74K - $124K/yr

Responsible for management of investigator site and Clinical Research Associate (CRA) activities for assigned studies. The In-House CRA will execute Clinical Affairs functions in accordance with Good ...

New

Tenacity Solutions LLC

Be Seen First

Clinical Research Associate

North Bethesda, MD · On-site

$115K - $135K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • PTO

Participate in study kickoff meetings, investigator meetings, and required training. * Support ... Certified Clinical Research Associate (CCRA) through ACRP or equivalent certification. * Previous ...

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Showing results 21-40

All JobsClinical Study Associate JobsClinical Study Associate Jobs in Reston, VA

Clinical Study Associate information

See Reston, VA salary details

$13

$32

$57

How much do clinical study associate jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for clinical study associate in Reston, VA is $32.81, according to ZipRecruiter salary data. Most workers in this role earn between $22.02 and $43.27 per hour, depending on experience, location, and employer.

What is a clinical study associate?

Clinical Study Associates (CSAs) are professionals who support the planning, execution, and monitoring of clinical trials in the pharmaceutical, biotechnology, or medical device industries. They help coordinate study logistics, maintain study documentation, and ensure compliance with regulatory requirements. CSAs often work closely with Clinical Research Associates, study coordinators, and investigators to ensure that trials are conducted according to protocol and timelines. Their role is essential in ensuring the accuracy and integrity of data collected during clinical research.

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

AspectClinical Study AssociateClinical Research Coordinator
CredentialsBachelor's degree, often in life sciences; certifications like CCRP or CCRA beneficialBachelor's degree in health sciences or related field; certifications like CCRP advantageous
Work EnvironmentPharmaceutical companies, CROs, clinical trial sitesHospitals, clinics, research centers
Job FocusMonitoring clinical trials, ensuring protocol compliance, data accuracyManaging daily trial activities, patient recruitment, data collection
Employer & Industry UsageCommonly employed in pharma and CROsPrimarily in healthcare and academic research settings

Both roles involve clinical trial oversight but differ in focus: Clinical Study Associates primarily monitor and ensure compliance during trials, while Clinical Research Coordinators manage daily trial operations and patient interactions. Understanding these distinctions helps in choosing the right career path or job search focus.

What are the key skills and qualifications needed to thrive as a clinical study associate, and why are they important?

To thrive as a Clinical Study Associate, you need a strong understanding of clinical research processes, regulatory requirements, and typically a life sciences degree. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and GCP certification are commonly required. Attention to detail, organizational skills, and effective communication set top performers apart in this role. These competencies ensure accurate study documentation, regulatory compliance, and smooth coordination across research teams.

What are some common challenges clinical study associates face when managing multiple clinical trials simultaneously?

Clinical Study Associates often juggle several clinical trials at once, which can present challenges such as prioritizing competing deadlines, maintaining accurate documentation for each study, and ensuring consistent communication with cross-functional teams. Staying organized and proactive is essential, as unforeseen protocol amendments or site issues can arise. Building strong relationships with site staff and utilizing effective project management tools can help CSAs navigate these complexities and deliver high-quality results.

What are the most commonly searched types of Clinical Study jobs in Reston, VA?

The most popular types of Clinical Study jobs in Reston, VA are:

What cities near Reston, VA are hiring for Clinical Study Associate jobs?

Cities near Reston, VA with the most Clinical Study Associate job openings:

Clinical Study Associate jobs near you
Infographic showing various Clinical Study Associate job openings in Reston, VA as of August 2026, with employment types broken down into 2% As Needed, 73% Full Time, 19% Part Time, and 6% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $68,251 per year, or $32.8 per hour.

Sr. TMF Manager

MacroGenics, Inc.

Rockville, MD • On-site

$34.25 - $46.75/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 11 days ago

Job description

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 150+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
This position provides TMF expertise and leads a cross-functional team in all aspects of management of the trial master file set up, design, and oversight. Responsibilities include managing timelines, and deliverables while maintaining quality and regulatory compliance.
Responsibilities and Job Duties:
TMF Planning
  • Partners, collaborates, and develops strong relationships within clinical operations and other functions, to understand the TMF needs to support corporate strategy, corporate objectives, and departmental objectives.
  • Leads enterprise-wide TMF strategy and lifecycle governance across global clinical programs.
  • Monitor technological advances and regulatory evolution and provide an analysis of TMF trends and changes including recommendations to the head of clinical operations for consideration.
  • Leads cross-functional alignment across Clinical Operations, QA, CROs and relevant external partners to drive TMF excellence.
  • Provides input into and/or drives the development of TMF operating procedures, work instructions, training materials, and tools.

TMF Delivery and Management
  • Owns the vendor governance framework, including KPIs, financial oversight and the escalation management for the TMF across all global clinical programs.
  • Work with the head of clinical operations systems to ensure continuing governance with the third-party vendors and that their support is aligned with departmental strategy, goals, and budget.
  • The Senior Manager of TMF Operations is responsible for all aspects of the 3rd party governance with input and oversight from the head of clinical operations systems including determination of key metrics to maintain oversight (% completeness, vendor performance, etc.)
  • Partner with CROs to ensure that system requirements for each trial are set up and delivered per timelines, quality, and budget, and that the end-of-study TMF integration is achieved.
  • Manage and lead TMF-related projects to ensure smooth system delivery and sound project management practices.
  • Maintain effective communication with clinical study teams, CRO staff and TMF vendor personnel throughout study start-up, maintenance and close out.
  • Propose, drive and support process improvement initiatives related to the TMF as required.
  • Lead projects to create, maintain and improve milestones and expected development tracking, timeline reports and dashboards for the TMF.
  • Perform general administrative tasks related to the TMF as required by the clinical study teams, directors, and the head of clinical operations systems.

TMF Inspection Readiness:
  • Work with audit inspection readiness teams, as needed, with a focus on preparing and supporting study teams for GCP and pre-approval related inspections on study TMF compliance and completeness.
  • Drives inspection readiness strategy, proactively identifying and mitigating TMF risks to ensure successful regulatory inspections.

TMF Subject Matter Expertise
  • Act as the TMF thought leader within MacroGenics, driving innovation through adoption of emerging technologies and industry best practices.
  • Provide principal leadership as the technical consultant for the TMF to ensure that changes and updates are implemented, and the system maintained appropriately.
  • Ensure awareness of trends in the industry in the field of innovation in trial management by scanning external and internal operational trends and evaluating new innovative technologies and practices.
  • Represent TMF technology innovation in trial management and develop a presence in industry-level forums. Act as representative on behalf of the head of clinical operations systems for select meetings and provide updates at operational and staff-wide meetings as required.

Minimum Qualifications
Education and Experience:
  • Bachelor's degree, with preference in physical, life sciences or computer sciences.
  • 7-10 years pharmaceutical industry or CRO experience with at least 4 years in trial management systems, clinical operations, and/or related clinical systems/technology innovation position.
  • Minimum of 4 years of exposure to using TMF on multiple domestic and international trials

Knowledge, Skills, and Abilities:
  • Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP), Good Documentation Practices, and International Council for Harmonization (ICH) E6(R2) and E6(R3) guidelines
  • Demonstrated knowledge of TMF systems, specifically Veeva TMF.
  • Understanding of the global drug development process, including international standards, health authorities and country/local regulatory requirements.
  • Demonstrated leadership in leading cross-functional teams and high-level project management expertise.
  • Demonstrated qualitative and quantitative skills in redesigning processes, improving productivity, and improving efficiency.
  • Ability to work independently with minimal oversight, however, is aware of when to escalate issues.
  • Excellent strategic thinking skills
  • Demonstrated matrix management skills and ability to influence internally and externally.
  • Excellent communicator and presenter
  • Experience with direct line management of team members or contractors
  • High level of competence and skill with TMF, web-based collaboration tools (MS Teams, SharePoint, etc.)
  • Willingness to travel up to 25%

Supervisory Responsibilities
  • Mentor and develop junior staff
  • May manage staff as required

Additional Information
The annual rate of pay for this position ranges from $144,300-$220,000. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.
The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Statement
MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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