Senior Clinical Trials Associate

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $75k - $99k / year

⏰ Full Time

🟠 Senior

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ProTrials Research Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

ProTrials Research Inc. is a clinical research organization (CRO) headquartered in the United States, offering a wide range of services to the pharmaceutical, biotechnology, and medical device industries. The company provides quality-driven site management, clinical monitoring, project management, data management, and supportive clinical development services. With a focus on therapeutic areas such as oncology, ophthalmology, central nervous system, infectious diseases, women's health, and medical devices & diagnostics, ProTrials is dedicated to delivering high-quality clinical research. Their services include project management, clinical operations, quality assurance, medical and regulatory support, and they also act as a functional service provider, emphasizing virtual trials and remote monitoring capabilities.

📋 Description

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

🎯 Requirements

• 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

🏖️ Benefits

• Full medical, dental, and vision insurance options for you and your family • Flexible PTO • 401(k) plan with a company match • Support and opportunities for professional growth and career advancement • Collaborative coworkers and work environment