Clinical Research Coordinator

Children's Healthcare Of Atlanta • Atlanta, GA

400d

About The Position

The position involves developing, implementing, and supporting the research process at Children's Healthcare of Atlanta. The role is essential in assisting investigators with study design, managing data, and ensuring compliance with regulatory guidelines, all while promoting a safe environment for patient care.

Requirements

• One year of research experience.
• Bachelor's degree in a scientific, health-related, or business administration related program or relevant experience in lieu of education.
• Basic Life Support (BLS) certification within 30 days of employment if role requires patient contact.
• ARUP Handling, Packaging and Shipping Infectious Substances or similar certification within 30 days of employment if role requires specimen acquisition.
• Collaborative Institutional Training Initiative (CITI) certification within 30 days of employment.

Nice To Haves

• Working knowledge of state and federal regulatory guidelines related to research.
• Good computer skills including working knowledge of a PC and Microsoft Office (Word, Access, and Excel).
• Self-directed and motivated to work independently toward short- and long-term goals.
• Good communication, organization, and interpersonal skills.
• Good working relationships with colleagues, subordinates, and superiors.

Responsibilities

• Develops, conducts, and facilitates research protocols.
• Supports investigators in writing study protocols.
• Performs participant screening, enrollment, study activities, and communication.
• Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment.
• Maintains equipment and supply resources for research studies.
• Completes data management activities and ensures data integrity.
• Assists in the development and completion of source documents and case report forms.
• Participates in sponsor correspondence, monitoring, and study meetings.
• Monitors compliance throughout all study activities and engages compliance oversight as needed.
• Directs patient interaction to conduct research protocols.
• Obtains informed consent by following policy, procedure, and regulatory requirements.
• Schedules study-specific visits in conjunction with ancillary departments.
• Administers various research surveys in accordance with research study requirements.
• Completes research-only testing as required and applicable per study and system requirements, including electrocardiograms.
• Performs phlebotomy if trained to do so.
• Provides research study education to participants as part of a study protocol.
• Completes documentation as needed within the medical record.
• Manages all regulatory processes related to clinical research activities.
• Completes Institutional Review Board preparation, submission, modifications, reporting, and termination activities.
• Maintains all licensure, certification, and system education requirements for role.
• Maintains all regulatory documents.
• Assists with facilitating grants, contracts, and financial tasks for research and clinical trials.
• Assists with supporting Principal Investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.
• Completes research administrative duties according to Children's policies regarding Epic enrollment, Clinical Trial Management System data entry, patient care invoice accuracy.
• Participates in education activities to support specific research activities and primary role at Children's Healthcare of Atlanta.
• May participate in departmental policy and quality projects.
• Completes departmental, system-wide, and study-specific education as required.

What This Job Offers

• Job Type: Full-time
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree