Job description

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Work Shift Variable

Work Day(s) Monday-Friday, Saturday, Sunday, Variable

Shift Start Time Variable

Shift End Time Variable

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 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

Experience

• 3 years of experience in clinical research with knowledge about the conduct of clinical trials, research principles, and methodologies/study design

Preferred Qualifications

• Master's degree in a scientific or health-related field
• Basic statistics

Education

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

Certification Summary

• 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

Knowledge, Skills and 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

Job Responsibilities
1.Develops, conducts, and facilitates research protocol at an expert level.
2.Provides substantial support for investigators in writing study protocols.
3.Leads participant screening, enrollment, study activities, and communication.
4.Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment.
5.Monitors process for services.
6.Acquires equipment and supply resources for research studies.
7.Provides leadership for data management activities.
8.Develops and evaluates source and case report form tools.
9.Manages data entry, ensures data integrity, supports statistical services needs, and collaborates with manager to assess data management needs.
10.Provides leadership for direct patient care interaction.
11.Administers various research surveys in accordance with research study requirements.
12.Completes research-only testing as required and applicable per-study and system requirements, including electrocardiograms.
13.Performs phlebotomy if trained to do so.
14.Provides research study education to participants as part of a study protocol.
15.Completes documentation as needed within the medical record.
16.Serves as an instructor and mentor for quality and education activities.
17.Monitors compliance throughout all study activities and engages compliance oversight as needed.
18.Maintains all licensure, certification, and system education requirements for role.
19.Coordinates educational activities related to study needs for study staff, investigator team, and patient care staff.
20.Initiates departmental policy and quality projects.
21.Collaborates with manager to incorporate system initiatives into departmental practices.
22.Provides leadership and training related to all regulatory processes related to clinical research activities.
23.Ensures Institutional Review Board preparation, submission, modifications, reporting, and termination activities.
24.Structures the maintenance of all regulatory documents.
25.Leads others in sponsor correspondence, monitoring, and study meetings.
26.Guides interdepartmental auditing of regulator practices.
27.Serves as a resource for facilitating grants, contracts, and financial tasks for research and clinical trials.
28.Independently provides services for investigators in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.
29.Serves as a collaborator and key contact for key business partners, including Emory, Georgia Tech, and University of Georgia.
30.Works collaboratively with manager to monitor metrics.

Primary Location Address 1405 Clifton Rd NE

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