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Clinical Trial Research Coordinator - Regulatory

Accel Research Sites Tampa, FL

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

An incredible opportunity is available to join Accel Research Sites as a Clinical Trial Research Coordinator in our Tampa, FL locations. Accel Research Site is a multi-therapeutic network of clinical research sites dedicated to delivering treatment options to patients and providers. We partner with the most innovative and significant pharmaceutical, biotechnology, and medical device companies in the world to advance healthcare and wellness in the communities we serve.

We are in search of a Regulatory Coordinator to oversee our various phases of our ongoing Clinical Trials from a Regulatory Compliance management perspective to support our Tampa FL research site. The Clinical Trial Research Coordinator will help to advance medical treatment by overseeing clinical trials and establishing a legal basis for the acceptance of new service methods. The Regulatory Coordinator is responsible for preparing regulatory submissions by assembling, reviewing, and coordinating information and requirements for investigational and licensure applications.

Key Responsibilities:

  • Track study approvals and expirations to ensure uninterrupted project approval and sponsor and investigator-initiated amendment notifications and submit amended protocols, summaries, and consents to the Institutional Review Board (IRB).
  • Maintain regulatory electronic document management system & prepares regulatory documents, including consent forms for submission to research review committees.
  • Maintain and track current Informed consent forms to ensure accurate use by the clinical coordinators.
  • Submit study renewal applications and study progress reports to the IRB. Coordinates with study sponsor, investigator, and IRB to complete study closure activities.
  • Assist with process and policy issues and guides form preparation and submission. Maintains current knowledge of federal and institutional guidelines and requirements governing research.
  • Recommend and implements regulatory process improvements.
  • Maintain current documents for research staff, e.g., CVs, licenses, certifications, training, and development of CVs for new personnel.
  • Maintain the regulatory database to include data entry, queries, and reports and ensures that the database is always current.
  • Complies with all standard operating procedures and quality control systems. Attend appropriate professional meetings and review scientific and medical literature to increase research and regulatory knowledge.
  • Performs as the key of contact to the site directors and all clinical operations on the assigned sites, with regulatory elements and requirements.
  • Reviews research personnel training for the assigned portfolio to ensure that participating personnel has appropriate training in human subjects research protection, HIPAA, Good Clinical Practices.

Required Skills and Education:

  • Bachelor's Degree in a related field.
  • Experience in healthcare, research and/or clinical trials required.
  • 3 years of relevant work experience.
  • 3 years in quality and/or compliance in a clinical research or healthcare setting.

What We Bring:

Excellence in Clinical Research since 1998

Our Core Values: Empathy, Trust, Innovation, Collaboration, Empowerment, Precision

Our Mission: We use scientific and human precision to deliver the best clinical trial results for our clients, providers, and patients.

Our Purpose: We bring together families, healthcare providers, and researchers to improve the quality of life for current and future patients.

Our Vision: The Accel Research Sites network will set the industry standard for patient-centered clinical research delivered in the modern healthcare ecosystem.

Learn more about us at https://accelresearchsites.com/about-us/

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Accel Research Sites

Address

Tampa, FL
33601 USA

Industry

Healthcare

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