Clinical Research Coordinator

Innovative Hematology, Inc.At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.Clinical Research CoordinatorAs a Clinical Research Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols.The OpportunityParticipate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator.Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and IHI.Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits.Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol.Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors.Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board.Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.Participate in internal quality assurance; review monitor reports for trends across studies.