New · posted Nov 10
IQVIA · Medical Devices
Clinical Research Associate, Sponsor Dedicated, IVD
- Carlsbad, CA +2 more
- On-site
- Full-time
- Associate & Specialist
The role
The Clinical Research Associate (CRA) will be responsible for designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to:
- Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements;
- Validating product performance claims;
- Supplying data for critical Regulatory submissions;
- Defining the functional and clinical utility of investigational products, and
- Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders.
The CRA is responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
What you need
Education Requirements
- Minimum - Bachelor's degree in science or relevant field.
Medical technology degree preferred, but not required if R&D background is adequate
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $90,200.00 - $197,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Experience, Skills and Knowledge Requirements
- ≥2 years of experience as a Clinical Research Associate, with specific in vitro diagnostics study experience
- CRA certification by recognized professional organization is a plus, but not mandatory
- Excellent oral and written communication skills
- Excellent planning, organizing, interpersonal and leadership skills
- Ability to work independently to make sound decisions and to analyze and solve problems
- Demonstrated experience in computer skills to include Microsoft Word, Excel, and basic templates
Pay and benefits
$90,200 – $197,500 a year
Employer providedHealth and welfare benefits
Incentive plans
Bonuses
Where you'll work
Carlsbad, CA +2 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: Carlsbad, CA (also Overland Park, KS · Durham, NC · Parsippany, NJ)
More jobs in Carlsbad, CA +2 moreWorking conditions
Job Function/Responsibilities
- Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout.
- Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met.
- Interfacing with other cross functional staff to support post launch activities.
- Reviewing cases with investigators to resolve discrepancies.
- Understanding and implementing federal regulations, helping to develop standard operating procedures in order to ensure that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and client policies and procedures.
Equal opportunity, accessibility and legal noticesIQVIA's statements, word for word
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 40% above the US median for Clinical Research roles at this level.
This roleEmployer provided
Associate & Specialist roles in California9 roles publishing pay
Associate & Specialist roles in the US65 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $90,200 | — | $197,500 |
| California (middle half) | $102,500 | $111,500 | $130,500 |
| All US (middle half) | $85,000 | $102,500 | $125,000 |
This role: IQVIA's own published range. Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Research
The general path across 243 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not IQVIA's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 18 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct4
- Investigations and CAPA2
- Validation and qualification2
- Collaboration and leadership2
- GMP and compliance1
- Lab testing and methods1
- Documentation and SOPs1
- Regulatory submissions1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Research work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
Company hiring pulse
IQVIA on Regulatory Jobs
- 89
- Open roles
- 89
- Distinct roles
- 28
- Locations
By discipline
- Clinical81 86%
- Regulatory10 11%
- Quality3 3%
By level
- Associate & Specialist48 51%
- Manager18 19%
- Senior & Principal15 16%
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Clinical Research Associate, Sponsor Dedicated, IVD at IQVIA
Open until filled. $90K–$198K a year, employer provided.