Research Regulatory Coordinator

Children's Healthcare of Atlanta•Brookhaven, GA

4d•Onsite

About The Position

Develops, implements, and supports the regulatory research process by assisting investigators in completion of the regulatory approval process for external and internal clinical research projects and clinical trials specific to the subspecialty of involvement. Functions as a liaison for the Institutional Review Board and study sponsors.

Requirements

Three (3) years of research experience.
Must demonstrate a high degree of clerical accuracy with attentiveness to detail and ability to organize data
Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to provide education and training
Knowledge of medical terminology
Self-directed and motivated to work independently toward short- and long-term goals and the ability to exercise independent judgment
Effective communication, organization, and interpersonal skills
Good computer skills, including working knowledge of a PC and Microsoft Office (Word, Excel, and PowerPoint)
Collaborative Institutional Training Initiative (CITI) within 30 days of employment

Nice To Haves

Association of Clinical Research Professionals (ACRP), Certified Research Associate (CRA) or Certified Clinical Research Coordinator (CCRC) OR Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professional (CCRP) OR comparable within 1 year of employment or 1 year of becoming eligible
Working knowledge of basic statistics
Regulatory Experience

Responsibilities

Manages departmental regulatory aspects for clinical trial and research activities.
Serves as the Institutional Review Board liaison for all regulatory activities within the department.
Develops, maintains, utilizes, and updates protocols as needed, and data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process.
Develops written consent/assent forms for each protocol which conform to federal and institutional guidelines to provide patients, parents, or guardians with detailed summaries to enable informed decisions.
Serves as the site regulatory contact for sponsored projects
Maintains regulatory documents for all study personnel, including, but not limited to, curriculum vitae, licenses, certifications and bio-sketches, Develops lay summaries for each protocol which are utilized by the Institutional Review Board in the initial review process.
Collaborates with departmental staff and faculty to develop and complete necessary documentation for initial study review, continuing renewals, amendments, and modifications, including the writing of consents, querying of systems to determine enrollment, and review of data safety monitoring reports.
Supports the Research Managers in the day-to-day activities of regulatory reporting for patients enrolled on research protocols.
Collaborates with all departments to ensure research complies with organizational guidelines and regulatory standards.
Assists in formulating departmental policies and guidelines.
Assists in preparation for audits and inspections as needed.
Provides reporting of all regulatory activities to department leadership as requested.
Works collaboratively with faculty and staff on all initial and ongoing protocols, amendments, and Institutional Review Board re-approvals in accordance with IRB-mandated policies and timelines.