Director Research Development Jobs in Nebraska (NOW HIRING)

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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.

Experience

• 3 years of experience in clinical research with knowledge about the conduct of clinical trials, research principles, and methodologies/study design
• Or 2 years of experience with advanced degree

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) or comparable certification within 1 year of becoming eligible for exam.
• 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

Develops, conducts, and facilitates research protocol at an expert level.

• Provides substantial support for investigators in writing study protocols, if applicable.
• Leads participant screening, enrollment, study activities, and communication.
• Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment.
• Acquires equipment and supply resources for research studies.
• Obtains informed consent by following Children's Healthcare of Atlanta policies, procedures, and regulatory requirements.
• Schedules study-specific visits in conjunction with ancillary departments.
• Facilitates data management activities at an expert level.
• Collaborates with manager to assess data management needs and 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.

Provides leadership for coordination of patient care to conduct research protocols.

• Provides research study education to participants as part of a study protocol.
• 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 and phlebotomy if trained to do so.
• Completes documentation as needed within the medical record.

Facilitates regulatory processes related to clinical research activities at an expert level.

• Provides support 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 and guides team auditing of regulatory practices.
• Leads others in sponsor correspondence, monitoring, and study meetings.

Leads education activities and quality initiatives to support specific research activities and primary role at Children's Healthcare of Atlanta.

• Maintains all licensure, certification, and system education requirements for role.
• Serves as an instructor and mentor for quality and education activities and engages compliance oversight as needed.
• Collaborates with manager to incorporate system initiatives into departmental practices.
• Assists with facilitating grants, contracts, and financial tasks for research and clinical trials.
• Assists investigators 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.
• 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.

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.