The Role
Supports clinical studies from planning through completion by maintaining eTMF records, processing study documents, tracking supplies and study activities, supporting audits and investigator meetings, coordinating vendors and sponsors, and maintaining clinical systems. Leads CTA onboarding and provides training and operational support to study teams while ensuring documentation quality and FDA readiness.
Summary Generated by Built In
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.
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 [email protected].
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.
Skills Required
- RN, bachelor's or advanced degree in biological sciences or a related field, or an equivalent combination of relevant experience, education, or training
- Two to three years of prior experience as a Clinical Trial Associate
- Advanced understanding and demonstrated proficiency in Clinical Trial Associate tasks
- Experience setting up and maintaining an electronic Trial Master File
- Proficiency with study start-up activities
- Solutions-oriented problem-solving approach
- Professional communication and interpersonal skills
- Strong Microsoft Word and Excel competency
- Ability to manage multiple tasks and changing priorities effectively
- Ability to read and understand regulatory documents and Standard Operating Procedures
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The Company
What We Do
ProTrials Research, Inc. is a mid-sized, full-service clinical research organization (CRO) founded in 1996. It partners with pharmaceutical, biotechnology, and medical device sponsors to provide clinical operations services, including study management, site monitoring, biometrics, and regulatory support. The company is a woman-owned business headquartered in Los Gatos, California, with a global reach, committed to delivering high-quality research to advance clinical trial success and improve patient health.
