Clinical Research Associate (CRA) II

Randstad USA; Lake Forest (IL); Remote; USD 60,000 - 80,000; Full time

Job summary

A leading company is seeking an experienced Clinical Research Associate for a fully remote role focused on managing Phase I-IV clinical trials. The ideal candidate will possess strong communication skills and a background in medical device clinical trials, contributing to impactful clinical studies.

Benefits

Health Insurance

401K contribution

Incentive and recognition program

Qualifications

• 3-5 years of experience in clinical research with strong understanding of GCP, FDA regulations, and ICH guidelines.
• Proven ability to monitor clinical trials and ensure adherence to study protocols.

Responsibilities

• Monitor Phase I-IV clinical trial sites for compliance with study protocols.
• Assist in protocol development and site training.
• Support evaluation and oversight of Contract Research Organizations (CROs).

Skills

Phase I

Phase II

Phase III

Phase IV

GCP

CTMS

Portfolio Management

Study Planning

ICH Regulations

Education

Bachelor's degree in a life sciences, healthcare, or related field

Job description

job summary:
Are you an experienced Clinical Research Associate with a passion for driving impactful clinical studies? This fully remote opportunity offers the chance to play a key role in the planning, execution, and monitoring of Phase I-IV clinical trials-helping bring innovative medical devices to market. The ideal candidate will have strong attention to detail, excellent communication skills, and prior experience in a regulated clinical research environment.

In this role, you'll collaborate with cross-functional teams to support protocol development, site training, CRO oversight, and data review. If you're looking to contribute to meaningful work in a dynamic and supportive setting-while enjoying the flexibility of a remote position-this could be the perfect next step in your clinical research career. Preference is given to candidates near major airports, with priority consideration for those on the East or West Coast.


location: Telecommute
job type: Contract
salary: $25.00 - 40.11 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:
Key Responsibilities:

• Monitor Phase I-IV clinical trial sites to ensure compliance with study protocols, ICH-GCP guidelines, and applicable regulations.
• Assist in protocol development and case report form (CRF) design to support study objectives and data accuracy.
• Coordinate and conduct site selection, initiation, and training visits to prepare investigators and staff for trial execution.
• Support the evaluation and oversight of Contract Research Organizations (CROs) to ensure quality and adherence to project timelines.
• Track patient enrollment, data collection, and CRF retrieval to ensure timely and accurate study progress.
• Participate in or lead study team meetings and assist in the preparation of regulatory submissions and study reports.
• Collaborate with internal stakeholders to address site performance issues and ensure data integrity throughout the trial lifecycle.

qualifications:
Required Skills & Qualifications:

• Must be authorized to work in the U.S. with no current or future need for visa sponsorship
• Must be located within the U.S. and near a major airport to allow for site visit flexibility.
• Bachelor's degree in a life sciences, healthcare, or related field.
• 3-5 years of experience in clinical research with a strong understanding of GCP, FDA regulations, and ICH guidelines.
• Proven ability to monitor clinical trials, track data, and ensure adherence to study protocols.
• Strong background in medical device clinical trials.
• Experience supporting or overseeing Phase IV studies.
• Familiarity with CRF development, CRO management, and site monitoring processes.
• Comfortable working independently in a remote environment, managing multiple priorities and timelines.

Preferred Skills:

• Previous experience working with AbbVie or in a similar large sponsor environment.

#LI-ST1


skills: Phase I, Phase II, Phase iii, Phase iv, GCP (Good Clinical Practice), CTMS, Portfolio Management, Study Planning, CTMS (Clinical Trial Management Systems), ICH Regulations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Required Skills & Qualifications:

• Must be authorized to work in the U.S. with no current or future need for visa sponsorship

• Must be located within the U.S. and near a major airport to allow for site visit flexibility.

• Bachelor’s degree in a life sciences, healthcare, or related field.

• 3–5 years of experience in clinical research with a strong understanding of GCP, FDA regulations, and ICH guidelines.

• Proven ability to monitor clinical trials, track data, and ensure adherence to study protocols.

• Strong background in medical device clinical trials.

• Experience supporting or overseeing Phase IV studies.

• Familiarity with CRF development, CRO management, and site monitoring processes.

• Comfortable working independently in a remote environment, managing multiple priorities and timelines.

Preferred Skills:

• Previous experience working with AbbVie or in a similar large sponsor environment.

#LI-ST1