Senior Clinical Trials Associate | Growth & Flexible PTO

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 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.