Community Health Network Indianapolis , IN 46218
Posted 1 month ago
Hours: Mon-Fri 8:00 am to 5:00 pm
Join Community
Community Health Network has an excellent opportunity available within our Clinical Research Department as a Research Regulatory Coordinator. If you are looking for challenging work and meaningful advancement, then you should consider a career with Community.
Make a Difference
The Research Regulatory Coordinator leads, coordinates and oversees regulatory processes across multiple studies of different therapeutic areas and phases, in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes independently. Studies may be large, nationwide, or moderately complex involving multiple sites and/or assessments/interventions. This role will maintain close, collaborative working relationships with key stakeholders in multiple product lines and Community Health Network to effectively manage regulatory activities for clinical trials.
Exceptional Skills and Qualifications
Manages regulatory activities for all stages of clinical trials for assigned department (s). Prepares and submits regulatory documents to Sponsor and IRB and works with clinical research team to ensure submission documents are up-to-date.
Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. Provides guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies.
Completes industry registrations and study feasibility questionnaires including receipt, tracking and correspondence with Sponsor/CRO/ARO
Prepare and submit start-up regulatory packets to Sponsor and IRB
Oversee study start-up activities to including reporting and communicating with stakeholders on a regular basis
Serve as a liaison to Sponsors/CRO/IRB/Investigators assuring continuity of service and problem resolution
Monitor approval status of open studies by completing timely reviews
Maintain master files of all regulatory-related documents
Assist in submission of Investigational New Drug (IND) applications including amendments and reporting
Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits
Ability to be detail oriented
Ability to be organized
Ability to perform basic computer functions
Ability to use customer service skills to provide an exceptional experience
Ability to work effectively within a team environment
Must be able to prioritize tasks; work well under stress, meet aggressive timelines, and problem solve to quickly and tactfully manage
challenging situations concerning customer groups
Must be willing to work flexible hours if needed
Must demonstrate intermediate competency in the use of the Internet and the following Microsoft applications: Word, Excel, Outlook
Your exceptional qualifications
business administration, or health care administration or research administration. (Required)
In lieu of the above education requirements, a combination of experience and education will be considered.
3+ years: Minimum of three (3) years of clinical research experience required. Prior regulatory experience preferred.
Clinical Research Certification is required once eligible and must be obtained three (3) years after hire.
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Why Community?
At Community Health Network, we build teams that deliver exceptional care through empathy, communication and collaboration. We consider ALL an integral part of the exceptional patient experience. We PRIIDE ourselves on not having employees but Caregivers. Join our Community as we make a difference in your community.
Caring people apply here.
Community Health Network