Research Regulatory Coordinator

Job Ref

2404742

Category

Professional & Business Support

Job Family

Academic Affairs

Department

Research-Academic Affairs

Schedule

Full-time

Facility

Visionary Enterprises, Inc

6626 East 75th Street

Indianapolis, IN 46250

United States

Shift

Day Job

Hours

Mon-Fri 8:00 am to 5:00 pm

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

• 2 year / Associate Degree : Bachelor’s or Associate degree in a related field. An applicable degree may be nursing, life sciences,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.

• 1) ACRP (Association of Clinical Research Professionals) CCRC (Certified Clinical Research Coordinator) or CCRA (Certified Clinical Research Associate)

OR

2) SoCRA (Society of Clinical Research Associates) CCRP (Certified Clinical Research Professional)

OR

3) MAGI (Model Agreements & Guidelines International) Clinical Research Contract Professional (CRCP) certification

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 complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Community Health Network does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex.