CPT Clinical Operations Coordinator Jobs
Clinical Operations Coordinator roles involve managing clinical trial logistics, regulatory documentation, and site coordination, work that maps directly onto healthcare administration and public health curricula. CPT authorization requires your DSO to confirm the role is an integral part of your program, so bring a detailed job description to your DSO before accepting any offer.
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Get Access To All JobsINTRODUCTION
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
THE ROLE
At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Associate Operator. Under close supervision, this position is responsible for a variety of assembly and non-assembly functions in support of manufacturing goals.
This position will be onsite in Carlsbad, CA.
THE RESPONSIBILITIES
- Operates equipment used to manufacture products.
- Checks and inspects products against departmental procedures.
- Responsible for recognizing product or equipment problems that arise during the manufacturing process.
- May be required to assist with the set-up and clean-up of manufacturing equipment.
- Responsible for Lean Initiatives.
- Carries out duties in compliance with established business policies.
- Performs other duties and projects assigned.
THE INDIVIDUAL
Required:
- 0 - 2 years of related experience required.
- Basic knowledge of regulations (FDA, ISO, OSHA, etc.).
- Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
- Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- This position is not currently eligible for visa sponsorship.
Preferred:
- High school diploma or equivalent.
- Experience in medical device manufacturing.
- MS Office and manufacturing systems.
THE KEY WORKING RELATIONSHIPS
Internal Partners:
Mechanics, Engineers and Management
External Partners:
Vendors and Contractors
THE WORK ENVIRONMENT
The work environment characteristics are representative of a manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. Works on assignments that are routine in nature.
THE PHYSICAL DEMANDS
Position requires ability to lift up to 50 lbs. on a regular basis. May be required to perform repetitive manufacturing processes (e.g., manual lamination, manual cassette assembly, pouch inspection, etc.) up to 90% of workday. Walking, standing, and/or sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.
SALARY TRANSPARENCY
The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $41,365.59 - $52,741.13 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
EQUAL OPPORTUNITY
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.
INTRODUCTION
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
THE ROLE
At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Associate Operator. Under close supervision, this position is responsible for a variety of assembly and non-assembly functions in support of manufacturing goals.
This position will be onsite in Carlsbad, CA.
THE RESPONSIBILITIES
- Operates equipment used to manufacture products.
- Checks and inspects products against departmental procedures.
- Responsible for recognizing product or equipment problems that arise during the manufacturing process.
- May be required to assist with the set-up and clean-up of manufacturing equipment.
- Responsible for Lean Initiatives.
- Carries out duties in compliance with established business policies.
- Performs other duties and projects assigned.
THE INDIVIDUAL
Required:
- 0 - 2 years of related experience required.
- Basic knowledge of regulations (FDA, ISO, OSHA, etc.).
- Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
- Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- This position is not currently eligible for visa sponsorship.
Preferred:
- High school diploma or equivalent.
- Experience in medical device manufacturing.
- MS Office and manufacturing systems.
THE KEY WORKING RELATIONSHIPS
Internal Partners:
Mechanics, Engineers and Management
External Partners:
Vendors and Contractors
THE WORK ENVIRONMENT
The work environment characteristics are representative of a manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. Works on assignments that are routine in nature.
THE PHYSICAL DEMANDS
Position requires ability to lift up to 50 lbs. on a regular basis. May be required to perform repetitive manufacturing processes (e.g., manual lamination, manual cassette assembly, pouch inspection, etc.) up to 90% of workday. Walking, standing, and/or sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.
SALARY TRANSPARENCY
The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $41,365.59 - $52,741.13 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
EQUAL OPPORTUNITY
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.
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Get Access To All JobsClinical Operations Coordinator CPT: Frequently Asked Questions
Does a Clinical Operations Coordinator role qualify for CPT authorization?
It qualifies when your DSO can tie the job duties directly to your enrolled curriculum. Clinical Operations Coordinator work typically involves protocol management, IRB coordination, and regulatory submissions, which align with healthcare administration, public health, and clinical research degree programs. Bring a duty-specific offer letter to your DSO so they can confirm the integral-part-of-curriculum requirement before approving CPT.
What documentation do I need from my employer to start CPT?
You need a formal offer letter that lists your job title, start date, hours per week, and a description of your specific duties. Generic offer letters that only state the job title are rarely sufficient. Your DSO uses the duty description to verify curriculum alignment, so ask your hiring manager to include protocol tracking, site coordination, or data management tasks by name.
Can I work as a Clinical Operations Coordinator part-time on CPT while finishing my degree?
Yes, and part-time CPT is often the strategically better choice. Part-time CPT, defined as fewer than 20 hours per week, does not count toward the 12-month full-time CPT threshold that eliminates OPT eligibility. Many clinical research employers accommodate part-time schedules during dissertation or capstone semesters, making this a practical option for students in their final year.
How do I find Clinical Operations Coordinator employers who already understand CPT?
Search Migrate Mate to browse Clinical Operations Coordinator roles at employers with active work-authorization filing history. Employers who have filed for sponsored workers before are far less likely to withdraw an offer when you explain CPT requirements. Academic medical centers, contract research organizations, and large hospital networks tend to have established processes for hosting CPT students in clinical operations roles.
Will CPT experience in clinical operations count toward future H-1B sponsorship?
CPT employment itself doesn't create an H-1B filing obligation, but it builds the documented work history that strengthens a future petition. Clinical Operations Coordinator is a specialty occupation under USCIS standards when the role requires a degree in a directly related field. Employers who hire CPT students in this role often convert strong performers to full-time sponsored positions, so use your CPT period to establish that track record.
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