Position Summary
Flexible work arrangements including virtual/hybrid work locations are an integral part of the School of Medicines Working Forward initiative. As such this positions work location is designated as hybrid. Please note that the designated work location is subject to change based on the units business needs. This position will serve as a Research Professional within the Pediatric Hematology and Oncology Division. The Research Professional is responsible for directing daily operations of clinical research study regulatory management and providing input in organization of new research administrative initiatives and strategies. This position is responsible for a wide range of duties including but not limited to: performing regulatory support for divisional clinical research projects IRB submissions amendments renewals contractual agreements and participant registration); identifying potential participants and retrieving consent; facilitating patient involvement in clinical research participation registries; coordination of biospecimens; validation of data collection documentation and analysis; and ensuring good clinical practice guidelines are followed. The Research Professional is expected to manage daytoday operations of multiple projects with considerable independence in the areas of project management planning design data collection/analysis decision making and problem solving. The position will report to the director of clinical research within the Pediatric Hematology and Oncology Division. 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 HematologyOncology. In addition to onsite 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 neurosurgeons; and nurses). The primary purpose of this position is to provide expertise to the UNC Pediatric Hematology/Oncology PHO Research team and assist the Directors Primary Investigators and faculty as necessary with study activation administration and regulatory requirement of research studies and internal auditing. These responsibilities relate to the mission of UNC PHO by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact research quality and safeguard institutional integrity.
Required Qualifications Competencies And Experience
Possess 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 a working knowledge of the 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. Advanced knowledge of clinical research coordination and working knowledge of medical terminology techniques and methodologies used in developing coordinating and managing clinical research projects. Possess strong decisionmaking skills and the ability to problemsolve and troubleshoot issues. Experienced with initiating maintaining and updating protocols with central and local IRBs and producing appropriate regulatory documents. Applicant should have expertise in database management and spreadsheets. 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. Ability to gather data and document procedures. Ability to plan work and coordinate multiple projects. Ability to contribute to the preparation and delivery of reports training audits and standard operating procedures guidelines. Teamoriented with skills and interest in working in a collaborative environment demonstrating respect for all colleagues and contributing to a positive work culture. 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. Ability to work on evenings weekends and/or holidays occasionally required. Be adaptable adjust to challenges with confidence and professionalism.
Preferred Qualifications Competencies And Experience
Minimum of 4 years of experience in research coordination or management. Experience with biospecimen based clinical research. Experience with REDcap database. Experience with academic IRB submissions renewals and modifications SOCRA / ACRP Certification is strongly desired.
Required Experience:
Staff IC