**Work Shift:** Please see job description for details. **Time Type:** Full time **Department:** CC033020 Clinical Research Operations **Summary:** Arkansas Children's Research Institute Oversees project implementation, assists with monitoring project progress, develops and manages operational databases, and ensures regulatory compliance. Contributes to grant proposal development, provides program administration support, and assists with preparing documentation that communicates research findings, project updates, or other relevant information to various audiences. The Arkansas Children’s Research Institute will be hiring a Research Program Manager for the Section of Pulmonary and Sleep Medicine. We are seeking individuals with a strong scientific background and expertise in scientific communication, writing, and conduct. Our team conducts innovative translational research which includes pharmacokinetic/pharmacodynamic studies in cystic fibrosis, as well as basic science approaches to understand the metabolism and transport of airway-targeted drugs. Our research group conducts population-based analysis of drug concentration, pharmacogenomics, and long-term impacts of modulator therapies in cystic fibrosis. Our primary focus is in children and adults with cystic fibrosis, but our work is applicable to all respiratory diseases that include airway-targeted medications. Ideal candidates will have an advanced degree (Masters or PhD), experience and expertise with laboratory-based techniques, some exposure or experience in human subjects research including clinical research, scientific publications in peer-reviewed journals, experience using statistical and/or graphics software to analyze and prepare data for publication, and experience with contributing to grant applications. The candidate must have excellent verbal and written communication skills, with experience working within a team-based environment. This role will work under the direct supervision of the Principal Investigator, Dr. Jennifer Guimbellot (Section Chief, Pulmonary and Sleep Medicine) and participate in group project meetings with clinical research staff, laboratory staff, and other colleagues at Arkansas Children’s Research Institute. The candidate will be required to work closely with trainees who participate in our project development. Duties will include but are not limited to: project management and oversight, grant writing and editing, manuscript writing and editing, assistance with regulatory activities related to the research program, participation in financial reconciliation and budgetary meetings, website development in collaboration with the PI, and supervision of other members of the research program to include clinical research staff, laboratory technicians, post-doctoral researchers, students, and other trainees. In addition, there will be opportunities to attend relevant scientific meetings, facilitate social media engagement, and assist with community engagement and fundraising efforts for the research program. Human subjects research training will be required. Current and anticipated projects include: ELECTRA Pregnancy Study: NIH R01-funded project focused on concentrations of modulator therapy in pregnant people with cystic fibrosis or are having babies with cystic fibrosis, across all trimesters and post-partum, including long-term monitoring of childhood development for infants exposed to in utero modulator use. Ensuring Access to Optimal Therapy in Cystic Fibrosis: ENACT Study: NIH R01-funded project focused on pharmacokinetic and pharmacodynamic variation for CFTR modulator therapy, identification of impactful novel pharmacogenetic variants contributing to variation in modulator therapy. ENACT includes a prospective observational study to evaluate the association of modulator concentrations with neuropsychological side effects such as anxiety, depression, and cognitive impairment that may arise from this study. Role of therapeutic drug monitoring to manage drug induced liver injury in CF: NIDDK P30-funded project focused on the potential association of CFTR modulator concentrations with drug induced liver injury (prospective study and a retrospective population-based study) Pharmacometric approaches to precision optimization of CFTR modulator response in cystic fibrosis patients: NIH K23-funded project focused on natural variation in cytochrome P450 metabolism enzymes in the liver and airway epithelia to understand the delivery, metabolism and transport in epithelia for airway-targeted drugs. How Diet and Body Composition Impact Drug Absorption and Response – The DOMINO Study: NIDDK pilot and feasibility study to evaluate the association of dietary composition, body composition, with CFTR modulator concentrations Other studies include evaluation of the concurrent use of medications in cystic fibrosis with variation in drug concentrations; evaluating drug metabolism and transport protein variation in different tissues; population-based studies of existing datasets to better understand long-term impacts of cystic fibrosis drug therapy. **Additional Information:** **Required Education:** Bachelors Degree or Equivalent Experience **Recommended Education:** **Required Work Experience:** Related Field - 5 years of experience **Recommended Work Experience:** **Required Certifications:** 1 of the following certifications is required - **Recommended Certifications:** Certified Clinical Reseach Coordinator (CCRC) - Academy of Clinical Research Professionals, Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates **Description** 1. Develops work plans used to achieve research goals and performance metrics. Provides oversight and reporting on team. 2. Evaluates team performance and assists with the definition and maintenance internal processes. Fulfills customer service standards and participates in the resolution of operational and customer service escalations. Serves as a champion of enterprise-wide culture, influencing culture change to support divisional objectives. 3. Assists with the facilitation of communications to the organization on research related projects and topics. Maintains effective working relationships with peers, stakeholders and leadership across the organization. 4. Assigns and reviews work, provides work instruction to on-the-job or formal training of team members. Evaluates performance of team members, providing continuous feedback. Manages discipline and performance issues. Hires and terminates team members. Identifies resource needs and develops recommendations for meeting such needs 5. Contributes to and/or manages resource allocation, budgets and financial performance for assigned programs and/or studies. 6. Oversees the collection, compilation, documentation, review and quality assurance of research data. Serves as a subject matter expert to internal and external stakeholders regarding protocol requirements, problem-solving programs, processes and best practices. 7. Plans and manages research-related activities and ensures work is performed according to research protocol as defined per contract, sponsor, organizational standards, and/or Institutional Review Board (IRB) guidelines. 8. Accountable for the development, implementation, maintenance and adherence to research strategies, policies, procedures and best practices. Monitors overall compliance with all applicable regulatory bodies. 9. Contributes to the development, maintenance and delivery of technical orientation and ongoing training. Accountable for ensuring credentialing requirements of team members are met and maintained. 10. Performs other duties as assigned Arkansas Children’s (https://www.archildrens.org/about-us) is the only hospital system in the state dedicated to caring for children, which enables us to uniquely shape the landscape of pediatric care in Arkansas. Arkansas Children’s is driven by four core values—safety, teamwork, compassion and excellence—which inform every action. Arkansas Children’s Hospital has received Magnet Status (https://www.archildrens.org/about-us/magnet-recognition) from the American Nurses Credentialing Center (ANCC), for nursing excellence and patient outcomes. And we are nationally ranked by U.S. News & World Report (https://www.archildrens.org/about-us/awards-and-recognition) for Cancer, Cardiology & Heart Surgery, Diabetes & Endocrinology, Nephrology, Neurology & Neurosurgery, Pulmonology & Lung Surgery and Urology. For more than a century, Arkansas Children’s has met the unique needs of children. But we’re more than just a hospital treating sick kids—our services include two hospitals, a pediatric research institute, foundation, clinics, education and outreach, all with an unyielding commitment to making children better today and healthier tomorrow. Arkansas Children’s Little Rock campus includes a 336-bed hospital with the state’s only pediatric Level 1 Trauma Center, burn center, Level 4 neonatal intensive care and pediatric intensive care, as well as a nationally-recognized transport service. And Arkansas Children’s Northwest (https://www.archildrens.org/locations/arkansas-childrens-nw) provides inpatient and emergency care, clinic rooms and diagnostic services to children in that corner of the state. _“Arkansas Children’s is a place of hope and comfort for children and parents. When you are at children’s, you are part of an elite team united with a common goal of saving children and making their lives better.”_ Michael – Business Operations Manager “Arkansas Children’s Hospital is a prestigious institution that cares for children.” Linda – Information Systems Analyst “We are an organization of care, love, and hope while we champion children.” Angela – Parking and Fleet Coordinator “Care, love, and hope for children!” Kathy – Administrative Assistant “When I think of my time here at Arkansas Children’s Hospital, I can honestly say that it has given me a unique perspective on the human condition, and the various roles that we all have in patient care. As a supply assistant, I have a very important job ensuring that the doctors and nurses have what they need to provide the world class medical care to the Children of Arkansas and surrounding states. Being a Champion for Children is more than a catch phrase, it is a way of life!” Nick – Supply Assistant Arkansas Children's provides equal employment opportunity to all persons without regard to age, race, color, religion, national origin or citizenship status, disability, military status, sexual orientation, gender identity or expression, pregnancy or any other category protected by federal, state and local laws. Further, Arkansas Children's will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.