Senior Clinical Trials Associate

About the role

ProTrials is seeking a Senior Clinical Trials Associate (Sr. CTA) to join their Clinical Operations team. The Sr. CTA acts as a pivotal teammate for the designated clinical study, involved in planning, implementation, and completion of clinical studies, interacting with study sites, vendors, sponsors, and study team. This is a non-exempt position.

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
• Absorb and assist in preparation of materials for investigator meetings, monitor workshops, and study manuals
• Absorb and assist in managing investigator meetings
• Absorb and assist in creating and developing meeting agendas and minutes with project teams, sponsors, or vendors with minimal comments
• Absorb and assist in vendor payments
• Lead, train, and provide support with 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

Qualifications

• None specified

Skills

• None specified

Benefits

• Full medical, dental, and vision insurance options for you and your family
• Flexible PTO
• Company match in 401(k) plan to help you reach your financial goals

Pay

N/A

Schedule

N/A