Work Schedule/Days: Day / Monday – Friday
Employment Type: Full-Time
Requisition #: 36837
Develops, implements, and supports the research process by assisting investigators in study design, completion of the approval process, and management of data specific to the subspecialty of involvement. Actively promotes a lean work culture by performing team member duties to encourage consistent use of lean principles and processes, including continually seeking work process improvements. Proactively supports efforts that ensure delivery of safe patient care and services and promote a safe environment at Children's Healthcare of Atlanta.
- Bachelor’s degree in a scientific or health-related field
- Basic Life Support (BLS) within 30 days of employment if role requires patient contact
- ARUP Handling, Packaging and Shipping Infectious Substances or similar within 30 days of employment if role requires specimen acquisition
- 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) within 1 year of employment
- Collaborative Institutional Training Initiative (CITI) within 30 days of employment
- 3 years of experience in clinical research with knowledge about the conduct of clinical trials, research principles, and methodologies/study design
- Master's degree in a scientific or health-related field
- Basic statistics
KNOWLEDGE SKILLS & ABILITIES*
- Self-motivated from a performance and professional development standpoint
- Commitment to the lab’s and Children's Healthcare of Atlanta's missions, goals, and values
- Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor
- Good computer skills, including working knowledge of a PC and Microsoft Office (Word, Access, Excel, and PowerPoint)
- Self-directed and motivated to work independently toward short- and long-term goals
- Good communication, organization, and interpersonal skills
- Must be able to successfully pass the Basic Windows Skill Assessment at 80% or higher rating within 30 days of employment
- Strives for good working relationships with colleagues, subordinates, and superiors
- Develops, conducts, and facilitates research protocol at an expert level.
- Provides substantial support for investigators in writing study protocols.
- Leads participant screening, enrollment, study activities, and communication.
- Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment.
- Monitors process for services.
- Acquires equipment and supply resources for research studies.
- Provides leadership for data management activities.
- Develops and evaluates source and case report form tools.
- Manages data entry, ensures data integrity, supports statistical services needs, and collaborates with manager to assess data management needs.
- Provides leadership for direct patient care interaction.
- 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.
- Serves as an instructor and mentor for quality and education activities.
- Monitors compliance throughout all study activities and engages compliance oversight as needed.
- Maintains all licensure, certification, and system education requirements for role.
- Coordinates educational activities related to study needs for study staff, investigator team, and patient care staff.
- Initiates departmental policy and quality projects.
- Collaborates with manager to incorporate system initiatives into departmental practices.
- Provides leadership and training related to all regulatory processes related to clinical research activities.
- Ensures Institutional Review Board preparation, submission, modifications, reporting, and termination activities.
- Structures the maintenance of all regulatory documents.
- Leads others in sponsor correspondence, monitoring, and study meetings.
- Guides interdepartmental auditing of regulator practices.
- Serves as a resource for facilitating grants, contracts, and financial tasks for research and clinical trials.
- Independently provides services for investigators in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.
- Serves as a collaborator and key contact for key business partners, including Emory, Georgia Tech, and University of Georgia.
- Works collaboratively with manager to monitor metrics.
Safety: Practices proper safety techniques in accordance with hospital and departmental policies and procedures. Responsible for the reporting of employee/patient/visitor injuries or accidents, or other safety issues to the supervisor and in the occurrence notification system.
Compliance: Monitors and ensures compliance with all regulatory requirements, organizational standards, and policies and procedures related to area of responsibility. Identifies potential risk areas within area of responsibility and supports problem resolution process. Maintains records of compliance activities and reports compliance activities to the Compliance Office.
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be an exhaustive list of all job duties performed by the personnel so classified.
Bending/Stooping – Occasionally (activity or condition exists up to 1/3 of time)
Climbing – Occasionally (activity or condition exists up to 1/3 of time)
Lifting – Occasionally (activity or condition exists up to 1/3 of time)
Pushing/Pulling – Occasionally (activity or condition exists up to 1/3 of time)
Sitting – Constantly (activity or condition exists 2/3 or more of time)
Standing – Occasionally (activity or condition exists up to 1/3 of time)
Walking – Occasionally (activity or condition exists up to 1/3 of time)
Ability to lift up to 40 lbs independently and greater than 40 lbs with assistance
Hearing/Speaking – Effective communication with employees, supervisors/managers and staff. Effective communications with patients and visitors, as required.
Some potential for exposure to blood and body fluids
Children’s Healthcare of Atlanta has been 100 percent committed to kids for more than 100 years. A not-for-profit organization, Children’s is dedicated to making kids better today and healthier tomorrow.
With 3 hospitals, 27 neighborhood locations and a total of 638 beds, Children’s is the largest healthcare provider for children in Georgia and one of the largest pediatric clinical care providers in the country. Children’s offers access to more than 70 pediatric specialties and programs and is ranked among the top children’s hospitals in the country by U.S. News & World Report.
Children’s has been ranked on Fortune magazine’s list of “100 Best Companies to Work For” for fourteen consecutive years and named one of the “100 Best Companies” by Working Mother magazine. We offer a comprehensive compensation and benefit package that supports our mission, vision and values. We are proud to offer an array of programs and services to our employees that have distinguished us as a best place to work in the country. Connect to our mission of making kids better today and healthier tomorrow.
Have questions about the recruitment process? Check out What to Expect.
Address: 1405 Clifton Road NE, Atlanta, GA 30322
Function: Research – Research