Peds-Hematology/Oncology-412011

Research Professionals

11/22/2024

12/06/2024

No

Permanent Staff (EHRA NF)

Senior Clinical Research Coordinator

EHRA Non-Faculty

20036195

NF0008685

Full-Time Permanent

1

40

North Carolina, US

$85,000 - $91,000

01/01/2025

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation’s top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.

OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.

OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.

Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.

Education: We will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented inter professional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.

Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine’s Working Forward initiative. As such, this position’s work location is designated as hybrid. Please note that the designated work location is subject to change based on the unit’s business needs.

This position will serve as a Senior Clinical Research Coordinator within the Pediatric Hematology and Oncology Division within the Department of Pediatrics. The Senior Clinical Research Coordinator is responsible for the planning, organization, conduct, and evaluation of multi-faceted clinical research protocols, including study execution, developing strategies and solutions to improve study processes and execution, providing reviews of other team members’ work product, and serving as mentor and subject matter expert.

The mission of the UNC Pediatric Hematology/Oncology Program is to treat and cure children and adolescents with cancer and blood diseases through participation in both national and locally designed treatment protocols. The program has active inpatient and outpatient services and an accredited fellowship program in Pediatric Hematology-Oncology. In addition to on-site clinical activities, physicians see patients in an outreach setting in Raleigh and Wilmington. In Chapel Hill, multidisciplinary clinics are dedicated to patients with hemophilia, sickle cell disease, brain tumors, late effects of anticancer therapy, vascular malformations, and general hematology/oncology. These clinics are staffed with social workers, psychologists, school teachers, and other pediatric subspecialists, in addition to the major oncology specialties (medical oncologists; radiation oncologists; general-, orthopedic-, and neuro-surgeons; and nurses).

The primary purpose of this position is to provide expertise oversight and management of clinical research staff to ensure safe, compliant, efficient, and effective conduct of oncology and bone marrow transplant clinical trials. This position provides expert level knowledge in clinical trial practices and regulations. This position works under the direct supervision of the Clinical Trials Operations Manager. This position manages clinical research staff assigned to various therapeutic areas within the Pediatric Hematology/Oncology (PHO) Research office providing daily management/supervision, resource and effort allocation, overseeing research compliance and data integrity, and assisting in strategic planning and operational support. This position creates and champions a collaborative and positive relationship dynamic with internal staff and external agencies/organizations.

Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

• Strong written and verbal communication skills.
• Must be able to work and communicate with diverse populations effectively and professionally.
• Ability to work independently as well as function as part of a team.
• Proficient with Microsoft Outlook, Excel, and Word.
• Possess an advanced knowledge of International Conference on Harmonization Good Clinical Practice (ICH GCP), Federal Regulations and Guidelines and demonstrate the ability to follow established regulations, procedures, and protocols. This includes but is not limited to, local, state, and federal guidelines governing clinical trials.
• Possess an advanced knowledge of clinical research coordination and working knowledge of medical terminology, techniques, and methodologies used in developing, coordinating, and managing clinical research projects.
• Clinical research experience
• Possess strong decision-making skills and the ability to problem-solve and troubleshoot issues.
• Strong organizational skills with the ability to manage large volumes of information
• High level of accuracy and attention to detail.
• Ability to learn quickly, work independently, prioritize tasks, and work under deadline pressure.
• Possess strong computer skills and a high level of comfort with technology
• Ability to gather data and document procedures.
• Ability to plan work and coordinate multiple projects
• Experience with preparation and delivery of reports, training, audits, and standard operating procedures guidelines.
• Experienced with initiating, maintaining, and updating protocols with IRBs and producing appropriate regulatory documents.
• Ability to contribute to preparation and delivery of reports, trainings and SOPs
• Customer oriented and ability to work within, build and lead a team
• Ability to communicate effectively, clearly, and professionally both verbally and in writing with clinical investigators, laboratory personnel, study sponsors, IRB, Office of Clinical Trials, and support staff.
• Exceptional interpersonal skills and excellent verbal and written communication skills in daily interactions with the ability to interpret and apply UNC policies and federal, state, and local regulations
• Team-oriented with skills and interest in working in a collaborative environment, demonstrating respect for all colleagues, and contributing to a positive work culture.
• Ability to work on evenings, weekends and/or holidays occasionally required.

• Therapeutic clinical trial coordination experience involving drugs and/or devices, which should be in oncology
• Supervisory experience
• Experience coordinating Pediatric clinical research studies
• Experience in Phase I, II, and III clinical research
• Experience navigating medical records and data extraction
• Experience leading a clinical research team.
• Experience in interviewing/hiring process and performance management
• Experience with academic IRB submissions, renewals and modifications
• SOCRA/ACRP certification is strongly desired

Not Applicable.