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Work ShiftDay
Work Day(s)Monday-Friday
Shift Start Time8:00 AM
Shift End Time4:30 PM
Worker Sub-TypeRegular
Job DescriptionProvides oversight for all aspects of clinical research occurring within the specified program and training and mentoring for clinical research personnel at site. 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. Communicates all relevant policy and procedure updates/revisions as directed by Manager, Research. Provides routine auditing/monitoring of ongoing trials for quality assurance purposes.
Experience - 4 years of experience in clinical research or 3 years of experience in clinical research with advanced degree
Preferred Qualifications - 2 years of experience in supervising staff
- Experience in creating and negotiating study budgets
- Experience in financial management
- Advanced degree
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 employment
- ARUP Handling, Packaging and Shipping Infectious Substances or similar within 30 days of employment if role requires specimen acquisition.
- Collaborative Institutional Training Initiative (CITI) within 30 days of employment
Knowledge, Skills and Abilities- Broad 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 communication, organization, and interpersonal skills
Job ResponsibilitiesDevelops, conducts, and facilitates research protocols at an expert level- Collaborates with manager to assess data management needs.
- Assists with development of source and case report form tools.
- Provides back-up data entry services and ensures data integrity.
- Assists with participant screening, enrollment, study activities, and communication.
- Provides substantial support to investigators in writing study protocols.
- Ensures protocol feasibility within ancillary departments.
- Works collaboratively with manager to monitor metrics.
- Manages a large or multiple smaller clinical trial projects.
- Administers various research surveys in accordance with research study requirements.
- Assists with identifying suitable grants for investigators.
- Identifies and completes research grant applications.
- Serves as back-up coordinator within identified service lines for all studies conducted in that service line.
- Authorizes purchases for research supplies and equipment maintenance if applicable.
- Leads others in sponsor correspondence, monitoring, and study meetings.
- Serves as a resource for facilitating grants, contracts, and financial tasks for research and clinical trials.
- Monitors expenditures and adherence to budget.
- Assists research administration, financial Operations, and grants accounting in racking research billing to ensure research procedures are billed appropriately and resolves invoice-related issues with all parties involved.
- Serves as resource for research administrative duties according to Children's policies regarding Epic enrollment, Clinical Trial Management System data entry, patient care invoice accuracy
Provides leadership for coordination of patient care to conduct research protocols- Provides leadership and training related to all clinical research activities.
- Provides research study education to participants as part of a study protocol.
- Performs phlebotomy if trained to do so.
- Completes research-only testing as required and applicable per-study and system requirements including electrocardiograms.
- Completes documentation as needed within the medical record.
Facilitates regulatory processes related to clinical research activities at an expert level- Oversees the maintenance of all coordinators' regulatory documents.
- Conducts interdepartmental auditing for quality assurance purposes.
- Trains coordinators on all Institutional Review Board-related activities such as submission, modifications, reporting, and termination activities.
Leads education activities and quality initiatives to support specific research activities and primary role at Children's Healthcare of Atlanta- Assists with departmental policy and quality projects.
- Maintains all licensure, certification, and system education requirements for role.
- Serves as an instructor and mentor for quality and education activities.
- Coordinates educational activities related to study needs for study staff, investigator team, and patient care staff.
- Provides training and assistance for research protocol development, conduct, and facilitation at an expert level.
- Provides leadership, training, and assistance for data management activities.
- Provides leadership, training, and assistance for direct patient care interaction.
- Provides leadership and expertise in study budgeting, sponsor interactions, budget and contract routing, feasibility assessments, account management, and reconciliation.
- Orients, supervises, and evaluates staff.
- Assist Supervisor and/or Manager with development of staff by: being available to teammates, acting as a resource to help complete complicated/complex tasks, providing on the job training to team, and seeking out opportunities to become actively involved in staff workflow and development.
- Provide Supervisor and/or Manager feedback on staff performance, educational needs, and workflow status.
- Leads or chairs committees or task forces.
- Collaborates with manager to incorporate system initiatives into departmental practices.
Primary Location Address1575 Northeast Expy NE
Job FamilyResearch
