Regulatory Compliance Coordinator

Regulatory Compliance Coordinator

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

· Work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives.

· Person will be responsible for coordinating the posting of registration and disclosures on clinicaltrials.gov, EudraCT and other registries for company-wide studies. This comprises supervision of the vendor as well as coordination of company internal processes to ensure compliance with all relevant legal obligations (primarily clinicaltrials.gov and EudraCT disclosure).

· Database proficient with registrations and disclosures preferred.

· Has the ability to work cross-functionally and meet required deadlines.

· Ensures trial disclosure is in compliance with applicable regulations globally.

· Develops and maintains strong internal relationships across all levels of the clinical organization.

· Escalates issues to management in an expedient manner.

· Continually train and remain in compliance with all current industry requirements as they relate to clinical trial disclosures.

· Reviews of clinical and regulatory documents and regulatory submissions for data accuracy, consistency, formal quality and readability, resolving identified issues in collaboration with authors in a productive fashion

· Coordinates all Client clinical disclosure activities, acting as primary intermediary between the disclosure vendor and Client contacts 30

· Works with Client contacts to identify and resolve compliance gaps 30

· Supports continual improvements by evaluating disclosure business process, suggests and implements improvements to enhance compliance, documents processes and trains relevant personnel 20

· Maintains Client disclosure trackers and produces metrics reports for management 10

· Maintains Client product information for use in disclosure activities 10

Qualifications

· Bachelor's degree required

· At least 3 years working in the pharmaceutical industry in an R&D environment.

· Solid knowledge of clinical trial transparency principles, preferably on an international level

· Strong attention to detail and the ability to work as a part of a team across multiple departments

· Strong communication and influencing skills