Research Regulatory Coordinator

Community Health Network; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Community Health Network in Indianapolis is seeking a Research Regulatory Coordinator. The role involves leading regulatory activities for clinical trials, ensuring compliance with institutional policies and regulations.

Candidates should have at least 3 years of research regulatory experience and an associated degree in nursing, life sciences, or related fields. Emphasis on attention to detail and teamwork is crucial. Join us to make a difference in community healthcare.

Qualifications

• Minimum of three years of research regulatory experience required.
• Clinical Research Certification required within three years after hire.
• Prior clinical research experience accepted.

Responsibilities

• Lead and oversee regulatory processes for clinical trials.
• Prepare and submit regulatory documents to Sponsor and IRB.
• Maintaining compliance with federal, state, and institutional guidelines.

Skills

Detail-oriented

Organizational skills

Customer service skills

Team collaboration

Education

Associate or Bachelor's degree in a related field

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

3+ years: Minimum of three (3) years of research regulatory experience required. Prior clinical research experience accepted.

Join Community Health Network was created by our neighbors, for our neighbors. Over 60 years later, “community” is still the heart of our organization. It means providing our neighbors with the best care possible, backed by state‑of‑the‑art technology. It means getting involved in the communities we serve through volunteer opportunities and benefits initiatives. It means ensuring our dedicated caregivers can learn and grow to stay at the top of their fields and to better serve our patients. And above all, it means exceptional care, simply delivered — and we couldn’t do it without you.

Make a Difference 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.

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.
• Prepares and submits start‑up regulatory packets to Sponsor and IRB.
• Oversees study start‑up activities, including reporting and communicating with stakeholders on a regular basis.
• Serves as a liaison to Sponsors/CRO/IRB/Investigators, assuring continuity of service and problem resolution.
• Monitors approval status of open studies by completing timely reviews.
• Maintains master files of all regulatory‑related documents.
• Assists in submission of Investigational New Drug (IND) applications, including amendments and reporting.
• Coordinates schedules of on‑site visits, including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits.

Core Competencies

• 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.
• Prioritizes tasks, works well under stress, meets aggressive timelines, and problem solves to quickly and tactfully manage challenging situations concerning customer groups.
• Willing to work flexible hours if needed.Intermediate competency in the use of the Internet and Microsoft applications: Word, Excel, Outlook.

Education & Experience

• Associate degree (or Bachelor’s) in a related field (nursing, life sciences, business administration, health care administration, or research administration). (Required)
• In lieu of the above education requirements, a combination of experience and education will be considered.
• Minimum three (3) years of research regulatory experience. Prior clinical research experience accepted.
• Clinical Research Certification is required once eligible and must be obtained three (3) years after hire.
• ACRP (Association of Clinical Research Professionals) CCRC (Certified Clinical Research Coordinator) or CCRA (Certified Clinical Research Associate)
• SoCRA (Society of Clinical Research Associates) CCRP (Certified Clinical Research Professional)
• MAGI (Model Agreements & Guidelines International) Clinical Research Contract Professional (CRCP) certification