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Clinical Trials Associate
2 months ago
We are seeking a highly skilled and experienced Senior Clinical Trials Associate to join our Clinical Operations team at ProTrials Research, Inc.
Key Responsibilities:- Set up and maintain the electronic Trial Master File (eTMF) to ensure compliance with regulatory requirements.
- Assist with Quality Assurance (QA) eTMF review and general FDA readiness to ensure the highest level of quality and integrity.
- Obtain, review, process, and track study-related documents to ensure accuracy and completeness.
- Develop, maintain, and disseminate multiple study trackers to ensure timely and efficient study progress.
- Participate and support sponsor audit activities to ensure compliance and quality.
- Manage and track investigational product supplies for study centers to ensure timely delivery and compliance.
- Assist in preparation of materials for investigator meetings, monitor workshops, and study manuals to ensure clarity and accuracy.
- Assist Clinical Project Manager/Client in managing investigator meetings to ensure effective communication and collaboration.
- Assist in creating and developing meeting agendas and minutes with project teams, sponsors, or vendors with minimal comments.
- Assist with vendor payments to ensure timely and accurate payment.
- Develop reliable relationships with Client/Sponsor and disseminate study-related information to project teams to ensure effective communication and collaboration.
- Lead, train, and provide support with the new CTA onboarding program to ensure a smooth transition and effective knowledge transfer.
- 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 read and understand regulatory documents and Standard Operating Procedures.
- 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.
This is a non-exempt, home-based position located in the Raleigh-Durham, NC area. The pay range is $65-95k/year. We offer competitive pay, career growth, full medical, dental, and vision benefit packages, 401(k) with match, commuter benefits, legal benefits, and the best coworkers, if we do say so ourselves.
ProTrials Research, Inc. is an equal opportunity employer. We do not discriminate against qualified applicants or employees with respect to any terms or conditions of employment based on race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.
