Senior Clinical Research Associate

ProTrials Research, Inc.; United States; On-site; USD 130,000 - 155,000; Full time

Benefits offered by this job

Full medical, dental, vision insurance

Flexible PTO

401(k) with company match

Growth opportunities

Great teammates

Job summary

ProTrials is a women-owned, WBENC-certified CRO focused on delivering high-quality clinical research. The Senior Clinical Research Associate will monitor and manage trials, ensuring compliance with protocol, SOPs, ICH GCP, and all applicable regulatory requirements, with travel up to 65%.

Responsibilities include site qualification, initiation, monitoring visits, data integrity reviews, and regulatory support.

Qualifications

• RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience.
• Detail-oriented with strong organizational and communication abilities.
• Extensive knowledge of FDA regulations and practical implementation.

Responsibilities

• Monitor clinical studies from qualification through close-out, including site visits.
• Train site personnel on protocols, SOPs, and case report forms.
• Oversee investigational supplies, dispensing, inventory, and reconciliation.
• Review lab sample handling, data queries, and data integrity.
• Maintain regulatory documentation and study files; ensure timely communications.
• Coordinate with study centers, investigators, and sponsors to resolve issues.
• Support CRA I/II staff with issue resolution and project needs.

Skills

Detail-oriented

Organizational skills

Interpersonal skills

Problem-solving

Flexibility

Task prioritization

FDA regulations

Travel ability

MS Office (Word, Excel, PowerPoint)

Education

RN or Bachelor and/or advanced degree in biological sciences or related field

Tools

Microsoft Word

Excel

PowerPoint

Job description

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.

Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.

We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.

ABOUT THE JOB

The Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Sr. CRA include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. Sr. CRAs may be required to travel up to 65%.

HERE IS WHAT YOU WILL DO:

• Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits
• Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Manage and track the preparation and return of investigational supplies at individual sites
• Monitor and document investigational product dispensing, inventory, and reconciliation
• Monitor and document laboratory sample storage and shipment
• Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
• Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
• Review data queries and listings, and work with study centers to resolve data discrepancies
• Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues
• Maintain complete and accurate study files and review files to ensure all appropriate documentation is present
• Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials
• Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues

HERE IS WHAT YOU BRING TO THE TABLE:

• RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position
• Detail-oriented
• Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
• Flexibility with changing priorities
• Ability to efficiently perform and prioritize multiple tasks
• Familiarity with the medical and pharmaceutical industries, and related terminology and practices
• Extensive knowledge of FDA regulations and their practical implementation
• Ability to travel, including by air or by car on short notice
• Proficiency in Microsoft Word, Excel, and PowerPoint

HERE IS WHAT WE OFFER:

• Your wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family.
• We know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally.
• You invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals.
• At ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward.
• We have the best coworkers, if we do say so ourselves.

$130,000 - $155,000 a year

Our salary ranges are determined by various factors. The actual base compensation for this position may vary depending on experience, market conditions, education/training, skill level, and location.

Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.

Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact [e-mail].

ProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.