Senior Clinical Trials Associate

ProTrials Research, Inc.; Raleigh (NC); On-site; USD 75,000 - 115,000; Full time

Benefits offered by this job

Full medical, dental, vision insurance

Flexible PTO

401(k) with company match

Growth opportunities and career dev

Collaborative team environment

Job summary

ProTrials Research, Inc. is seeking a Senior Clinical Trials Associate (Sr. CTA) to join our Clinical Operations team. You will help plan, implement, and complete clinical studies, interact with sites, vendors, sponsors, and study teams, and maintain clinical systems and documentation.

The Sr. CTA role is non-exempt and focuses on ensuring FDA readiness, eTMF accuracy, and timely study trackers. Join a women-owned CRO committed to global health and professional growth.

Qualifications

• RN, Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training
• 2-3 years of prior experience as a Clinical Trial Associate preferred
• Advanced understanding and demonstration of proficiency in CTA tasks
• Experience setting up and maintaining eTMF
• Proficient with study start-up activities
• Solutions-oriented approach to problem solving
• Professional and engaging communication and interpersonal skills
• Remarkable Microsoft Word and Excel competency
• Ability to perform multiple tasks effectively and manage changing priorities
• Ability to read and understand regulatory documents and Standard Operating Procedures

Responsibilities

• Set-up and maintain the electronic Trial Master File (eTMF)
• Assist with Quality Assurance (QA) eTMF review and general FDA readiness
• Obtain, review, process and track study related documents
• Develop, maintain and disseminate multiple study trackers
• Participate and support sponsor audit activities
• Manage and track investigational product supplies for study centers
• Assist in preparation of materials for investigator meetings, monitor workshops, and study manuals
• Assist Clinical Project Manager/client in managing investigator meetings
• Assist in creating and developing meeting agendas and minutes with project teams, sponsors, or vendors with minimal comments
• Assist with vendor payments
• Develop reliable relationships with client/sponsor and disseminate study related information to project team
• Lead, train, and provide support with the new CTA onboarding program

Skills

CTA tasks proficiency

Multitasking

Communication skills

MS Word & Excel

Education

RN or Bachelor or higher in biological sciences

Tools

eTMF setup

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

Are you a highly motivated Clinical Trials Associate who is looking to join a remarkable company that cares about your professional growth? ProTrials is seeking a Senior Clinical Trials Associate (Sr. CTA) to join us as a critical member of our Clinical Operations team.

The Sr. CTA acts as a pivotal teammate for the designated clinical study. The Sr. CTA is engaged in the planning, implementation, and completion of clinical studies and will regularly interact with the study sites, vendors, sponsors, and study team. The Sr. CTA also plays a part in accurately updating and maintaining the clinical systems. The Sr. CTA prepares, distributes, reviews, and archives clinical documentation and reports.

This role is a non-exempt position.

HERE IS WHAT YOU WILL DO:

• Set-up and maintain the electronic Trial Master File (eTMF)


• Assist with Quality Assurance (QA) eTMF review and general FDA readiness


• Obtain, review, process and track study related documents


• Develop, maintain and disseminate multiple study trackers


• Participate and support sponsor audit activities


• Manage and track investigational product supplies for study centers


• Assist in preparation of materials for investigator meetings, monitor workshops, and study manuals


• Assist Clinical Project Manager/client in managing investigator meetings


• Assist in creating and developing meeting agendas and minutes with project teams, sponsors, or vendors with minimal comments


• Assist with vendor payments


• Develop reliable relationships with client/sponsor and disseminate study related information to project team


• Lead, train, and provide support with the new CTA onboarding program

HERE IS WHAT YOU BRING TO THE TABLE:

• RN, Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training


• 2-3 years of prior experience as a Clinical Trial Associate preferred


• Advanced understanding and demonstration of proficiency in CTA tasks


• Experience setting up and maintaining eTMF


• Proficient with study start-up activities


• Solutions-oriented approach to problem solving


• Professional and engaging communication and interpersonal skills


• Remarkable Microsoft Word and Excel competency


• Ability to perform multiple tasks effectively and manage changing priorities


• Ability to read and understand regulatory documents and Standard Operating Procedures

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.