Senior Clinical Research Associate

The company 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 the company, 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.

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 the company, 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.

Except as otherwise permitted or required by applicable law or regulatory requirements, the company 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 [link for members]

The company is an equal opportunity employer. The company 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.