Research Specialist (Non-Clinical)

Note: If you are CURRENTLY employed at Children's and/or have an active badge or network access, STOP here. Submit your application via Workday using the Career App (Find Jobs).
Work Shift Day

Work Day(s) Monday-Friday, Variable

Shift Start Time 9:00 AM

Shift End Time 5:00 PM

Worker Sub-Type Regular

Children’s is one of the nation’s leading children’s hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We’re committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children’s.

Job Description Provides oversight for all aspects of clinical research occurring within a specified program. Develops, implements, and supports the research process at an expert level by assisting investigators in study design, completion of the approval process, and management of data. Provides guidance and assistance in protocol development, serving as back-up coordinator to provide ongoing support for all trials in the specified program as needed. Provides routine auditing/monitoring of ongoing trials for quality assurance purposes.

Experience
5 years of clinical research or 4 years of experience in clinical research with an advanced degree

Preferred Qualifications
Advanced degree
Experience in creating and negotiating study budgets.

Education
Bachelor’s degree in a scientific or health-related field

Certification Summary
Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of exam eligibility
Collaborative Institutional Training Initiative (CITI) within 30 days of employment

Knowledge, Skills, and Abilities
Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.
Recognized as the Subject Matter Expert within clinical research processes and regulatory requirements.
Knowledge of medical terminology.
Working knowledge of applicable business systems including EPIC, CTMS, Microsoft Office, and Workday.
Excellent project management skills with demonstrated ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
Strong knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor
Self-directed and motivated to work independently toward short and long-term goals
Good written and oral communication, organization, problem-solving, and interpersonal skills

Job Responsibilities
Develops, conducts, and facilitates research protocols at an expert level
Provides training and assistance for research protocol development, conduct, and facilitation at an expert level.
May oversee some financial tasks related to research and the Clinical Research Department, such as budget preparation and compliance to budget guidelines.
Provides assistance with the grant application process for program-specific grants and clinical research/trials in collaboration with appropriate personnel and ancillary departments.
Collaborates with Research Administration to facilitate the pre-award process, including contract and budget routing and feasibility review.
Leads others in sponsor correspondence, monitoring, and study meetings.
Analyzes the feasibility of establishing new research and/or institutional protocols.
Serves as a resource for facilitating grants, contracts, and financial tasks for research and clinical trials in collaboration with appropriate personnel and ancillary departments.
Provides leadership and expertise in study budgeting, sponsor interactions, budget and contract routing, feasibility assessments, account management, and reconciliation.
Tracks research billing to ensure research procedures are billed appropriately and resolves invoice-related issues with all parties involved.

Provides leadership for coordination of patient care to conduct research protocols
Leads participant screening, enrollment, study activities, and communication.
Completes research-only testing as required and applicable per-study and system requirements, including electrocardiograms or phlebotomy (if trained to do so).
Administers various research surveys in accordance with research study requirements.

Facilitates regulatory processes related to clinical research activities at an expert level
Serves as a site regulatory contact for sponsored projects and assists with site initiation and monitoring visits.
Develops written consent forms for protocols which conform to federal and institutional guidelines to provide patients, parents, or guardians with detailed summaries to enable informed decisions.
Completes and maintains regulatory documents for all study personnel, including curriculum vitae, licenses, financial disclosures, Form FDA 1572, confidentiality agreements, training logs, and delegation of duties logs.
Oversees quality monitoring and reporting activities.
Initiates departmental policy and quality projects.
Ensures Institutional Review Board preparation, submission, modifications, reporting, and termination activities.
Works with Study Team to ensure research is conducted in compliance with local, state, and federal regulations, policies, standard operating procedures, and guidelines as well as Children’s Healthcare of Atlanta policies and guidelines.

Leads education activities and quality initiatives to support specific research activities and primary role at Children’s Healthcare of Atlanta
Serves as an instructor and mentor for quality and education activities.
Participates in educational activities related to study needs for study staff, investigator team, and patient care staff.
Leads or chairs committees or task forces.
Provides leadership, training, and assistance for data management activities.
Manages preparation for internal and external audit events.
Works collaboratively with manager to monitor metrics and incorporate system initiatives into departmental practices.
Provides back-up data entry services and ensures data integrity.
Completes documentation as needed within the medical record.

Children’s Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.

Primary Location Address 1001 Johnson Ferry Rd

Job Family Research