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We are seeking a Regulatory Compliance Associate to join our team.

This is a remote position with some travel.

 

#LI-JD1

  • Maintain the regulatory documents at the site.
  • Follows the organization’s SOPs and provides guidance with staff comprehension and compliance with the SOPs. 
  • Assist with and coordinate development of clinical trial support documents.
  • Ensures maintenance of regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies.
  • Ensures IND safety reports are distributed to investigators and research team for review.
  • Ensures that all required regulatory documents are updated in the site’s regulatory binder throughout the life of the study.
  • Assembles, reproduces and archives (hard and electronic copies) technical documents, as appropriate for the document type.
  • Report on the status of clinical trials.
  • Facilitate communication with the IRB and/or Sponsors.
  • Ensure safety of all patients treated with investigational products and assist with all regulatory filings in this regard.
  • Represents Clinical Research Advantage/Radiant Research, Inc. to sponsor representatives and regulatory agencies.
  • Performs quality reviews of data generated from clinical trials.
  • Collaborates with the research team to facilitate overall protocol operations.
  • Keep documents organized and ready for audit and ready for regulatory filings when required.
  • Identifies problems and issues and takes corrective action and/or escalates appropriately.
  • Track sponsor and IRB approvals and renewals.
  • Generates and reviews reports of regulatory data using appropriate systems.
  • Assist in training programs as requested.
  • Uses appropriate IT and software tools to ensure the correct format and presentation of documents.
  • Ensures all assigned tasks are conducted in accordance with federal regulations and ICH/GCP.
  • Achieves appropriate quality standards in all documentation within the timelines dictated by project plans and company expectations.
  • Prioritizes personal workload in line with agreed project plans.
  • Support team activities and assume responsibility for activities, as necessary, to fulfill company needs.
  • Participates in business development activities.
  • May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
  • Travel as needed (Approx 20%)
  • A Bachelor’s degree and a minimum of 2+ years’ experience in Clinical Research, or an equivalent combination of education and experience is required.  Knowledge of GCP/ICH regulatory guidelines and clinical trial processes is required.  Document management and/or Regulatory experience a plus. 
  • Strong proficiency in Microsoft Office programs (Outlook, Word) and Web applications;
  • Exceptional organizational skills, attention to detail and follow through;
  • Ability to type proficiently (35+ wpm);
  • Excellent verbal and written communication skills;
  • Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers;
  • Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads;
  • Must be professional, possess a high degree of urgency and self-motivation, and have a strong
  • Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other confidential information.

We offer a comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!  

We are an Affirmative Action and Equal Opportunity Employer.

Accelerated Enrollment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrollment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

The array of  AES services include strategic enrollment solutions that offer speed, certainty and commercial value to our clients. Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.