Job Description

Coordinates all clinical research activities with moderate supervision. Adheres to the service values and principles of research ethics. The balance between patient-facing and administrative data tasks varies according to the specific requirements of each research program. Essential Job Functions: Coordinates and manages the initiation and regulatory compliance of clinical research studies, including preparing all necessary documents for IRB and sponsor review, coordinating study conduct across departments, and securing required approvals. Manages study documents, including regulatory binders, source documents, and correspondence, while maintaining adherence and compliance to research protocols. Coordinates and oversees all aspects of clinical research visits, including arranging and conducting visits, conducting site qualifications, initiation, monitoring, and close-out visits. Collects specimens from subjects and ensures proper processing, records data on source documents and electronic systems, and conducts literature searches while assisting with QA/QC procedures to ensure data accuracy and protocol compliance. Manages participant engagement throughout clinical trials by identifying eligible subjects, conducting informed consent processes, coordinating reimbursement, verifying eligibility, and serving as the primary patient liaison for study-related inquiries and support. Manages and oversees all aspects related to supplies and equipment inventory, including preparation of lab kits and requisitions. Tracks and manages deadlines for grants and deliverables. Prepares abstracted and coded data for subsequent processing and analysis, while also developing codebooks for data dictionaries to ensure comprehensive data organization and accessibility. Participates actively in investigator meetings, contributing to the ethical conduct of research through educational initiatives, and represents research findings at meetings and conferences. Assists with financial aspects of studies including invoicing and billing management. Other job functions as assigned. Knowledge, Skills, and Abilities: Bachelor’s degree and one year research experience required. A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job. Proficient organizational skills with ability to manage multiple studies. Proficient verbal and written communications skills. Proficient knowledge of FDA, HSR, and GCP Guidelines. Proficient analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems. Proficient entry level leadership skills. Recognizes the need to prioritize tasks, problem solve, and work with others. Assists to foster an inclusive environment where all team members feel valued and respected.

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