CCT Research is adding two Clinical Research Regulatory Specialists to our team to join us in our Mission: Leading today's trials. Offering tomorrow's hope. And help make progress toward our Vision: For future generations to live in a world free of disease.
Your role as Clinical Research Regulatory Specialist is responsible for the completion, accuracy, and submission of all documentation related to research protocols. The regulatory team supports the smooth coordination of research activities with clinical research staff, sponsors, CROs, IRBs, and other internal stakeholders.
This position provides regulatory oversight, organization, and coordination of research involving physicians, clinicians, and other departments.
The ideal candidate will be self-driven and thrive independently, effectively communicate across multiple departments, and be thorough with details. This position will be a combination of office-based (Arizona or Omaha, Nebraska) and remote.
- You are Self-driven and capable of planning, organizing multiple projects, setting priorities, and working with efficiency and accuracy in a fast-paced environment.
- Effective communication is important to you.
- Software savvy. Microsoft Office programs (Outlook, Word, Excel). Use and edit Adobe PDF documents. You are comfortable using and learning software systems to organize information, produce reports, and maintain controls on documents.
- Type proficiently (35+ wpm)
- You have excellent interpersonal skills for a versatile work environment, working independently or with colleagues, supervisors, and external sources.
- Adapt well to changes in responsibilities and workloads.
- Integrity and confidentiality are imperative to you, and you can strictly follow HIPAA guidelines, subject matters, and other confidential information.
- You are a problem solver, think critically and creatively, and provide support through a consultative role.
- Understand human research policies, regulations, procedures, and standards according to FDA, ICH, GCP guidelines.
- Bachelor's Degree in healthcare or science-related field with prior Regulatory Specialist experience is preferred. An equivalent combination of education and experience may be considered for this position.
Regulatory Specialist I Essential Job Responsibilities:
- Update Clinical Trials Management System (CTMS) as needed with essential profile information (CVs, medical licensures, laboratory accreditations), IRB status, consent form versions (protocol/consent form evolution), and safety information.
- Prepare regulatory documentation packets and create all FDA 1572 Forms for IND filings. Distribute financial disclosure forms, protocol signature pages, and FDA 1572 forms to obtain investigator and staff signatures. Ensures all necessary documents are submitted to the Sponsor company to activate protocols.
- Post regulatory documents, such as protocols, amendments, consent forms, and SAE forms on the CTMS.
- Submit initial applications for study approval to the IRB. Submit continuing review reports, closeout reports, and other materials to the IRB for approval and process accordingly.
- Prepare, maintain, update, and audit study-specific regulatory files, IRB files per FDA guidelines and resolve queries, as necessary.
- Distribute IRB documentation and post IRB meeting information to study sponsors, research, and clinical staff.
- Communicate effectively with the company's coordinators, marketing staff, and management; pharmaceutical companies; IRBs; study sponsors; and other team members.
- Advise others on regulatory and compliance matters.
- Identify and interpret relevant regulatory guidelines.
- May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
- Contribute to essential medical research to make a positive impact in the future of healthcare. The work you do now can help millions of people live healthier lives.
- Grow with us! Be part of a growing company with a culture of growth and support and encourages promotion within. We have career pathway plans for advancing your role.
About CCT Research:
We're an integrated clinical research site network with skilled physician partners, proven processes, and technology solutions. Together, we research to validate innovative, life-saving medical treatments so that patients have safe and effective options to overcome their disease and bring hope to future generations.