Senior Clinical Trials Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Establish and uphold the electronic Trial Master File (eTMF).

• Assist in Quality Assurance reviews of the eTMF and ensure overall FDA readiness.

• Acquire, assess, process, and monitor study-related documents.

• Create, sustain, and distribute various study trackers.

• Engage in and facilitate sponsor audit activities.

• Oversee and monitor investigational product supplies for study sites.

• Aid in the preparation of materials for investigator meetings, monitor workshops, and study manuals.

• Support the Clinical Project Manager/client in coordinating investigator meetings.

• Contribute to the creation and development of meeting agendas and minutes with project teams, sponsors, or vendors.

• Assist with processing vendor payments.

• Cultivate trustworthy relationships with clients/sponsors and communicate study-related information to the project team.

• Lead, train, and assist in the onboarding program for new Clinical Trial Associates (CTAs).

⛳️ Requirements

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

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

• Advanced knowledge and demonstrated proficiency in Clinical Trial Associate tasks.

• Experience in setting up and maintaining the eTMF.

• Proficiency in study start-up activities.

• Solutions-oriented mindset for effective problem-solving.

• Professional and engaging communication and interpersonal abilities.

• Exceptional competency in Microsoft Word and Excel.

• Capacity to manage multiple tasks efficiently while adapting to shifting priorities.

• Ability to read and comprehend regulatory documents and Standard Operating Procedures.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance options for you and your family.

• Flexible Paid Time Off (PTO).

• 401(k) plan with company matching.

• Support and opportunities for professional development and career advancement.

• Collaborative colleagues and a supportive work environment.