Clinical Research Coordinator

Primary Duties and Responsibilities:Screen and identify potential study participants from review of protected health information based on protocol eligibility criteria. Based on knowledge and experience, understand to interrupt the feedback to identify potential study participants. Consent study participants including discussion of procedures and tests and ensure that Informed Consent documents are properly signed prior to the start of the study. Identifying and scheduling screening procedures to confirm study participant eligibility and enrollment on clinical trials. Collaborate with insurance coordinators, clinical coordinators and/or research nurse to obtain insurance verification for standard of care procedure. Schedule and coordination of research related services such as Infusions, radiology and other research related services.Interviews and assess (i.e. compliance of medicines, quality of life/diary forms, A/Es) at study visits for data required by the protocol. Conduct study related assessments/interventions (i.e. questionnaires). Schedule or coordinate scheduling of study participant appointments and confirming study participant visits and procedures in Oncore and Nimblify for study participant reimbursement.Monitor clinical team compliance with required study procedures and GCP standards. Record and document protocol deviations. Complete and report non-compliance in collaboration with study team. May oversee/collaborate with CRS. Coordinate with Sponsor, Clinical Research Specialist and study team to resolve queries and ensure study integrity.Educate ancillary staff/departments about the clinical trial. Develop or assist with the development of protocol order sets. Communicate with Sponsors, prepare for monitoring visits (or assist/oversee CRS performing these functions). Participates in required teleconferences, on-site meetings and off-site investigator meetings.Extract data from source documents, complete case report forms. Review study participant SAE information and assist PI in submission and/or determination of SAE. Update calendars and study participant status in Oncore.Minimum Qualifications:Bachelor's degree in science or a health-related field and 2 years of clinical research experience OR Associate's degree in science or a health-related field and 3 years of clinical research experience.Combinations of related education and experience may be considered.PreferredSOCRA/ARCP Clinical Research Certification Upon HireRequired knowledge, skills, and abilities:This position requires excellent oral and written communications skills, organizational skills, and the ability to develop and maintain a rapport with professional, study participants and families.It requires knowledge and understanding of case report forms, research documentation, research methods and study protocols. Must be able to read, understand and communicate complex scientific and clinical information.Ability to work as a team player maintain and manage conflicts and resolve problems effectively.Ability to attend regular scheduled meetings (weekly, monthly and team).High degree of accurate and organized records and work with some level of independence.Strong interpersonal skills and extensive judgment are required to appropriately respond to participants, family and research staff.Proficient use of computers, strong attention to detail and the ability to multi-task are also necessary.Equipment utilized: OnCore, Microsoft officeLevel of Decision Making:This position will follow site policies, IRB, FDA and GCPs.The position is responsible for protocol compliance.The position may contribute to SOPs and policies at the site.This position will determine study participant eligibility, communicate directly with physicians, research nurses, study participants and the study team to ensure compliance with the protocol.Scope and Impact:This position is screening and consenting participants; thus interacting with the public and determining eligibility and compliance on clinical trials.This position must closely interact with the PI and study team, and ancillary departments and function autonomously at the site.This is a highly regulated, high profile (customer service with the public a multi-disciplinary parties) position and failure to comply with regulations including compliance with the protocol could result in sanctions by regulatory bodies.Direction Provided to Others:Multiple positions, CRS, CDC and Lab TechsPhysical Requirements:Working in a face-paced environment (Clinics) and may be sitting for long periods of time.