Note: The job is a remote job and is open to candidates in USA. ProTrials Research, Inc. is a Contract Research Organization supporting clinical research in the pharmaceutical, biotech, and medical device industries. The Senior Clinical Trials Associate supports the planning, implementation, and completion of clinical studies by coordinating documentation, study systems, vendors, sponsors, and clinical study teams. The role also contributes to audit readiness, investigator meetings, and CTA onboarding and training.
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
- RN, Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training
- 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
- 2-3 years of prior experience as a Clinical Trial Associate preferred
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, skill expansion, and career advancement.
- Collaborative community and supportive coworkers.
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