The Research Assistant Clinical will support various research studies, including federal and nonfederal funded grants, clinical trials, and community-based projects, supervised by the Clinical Research Supervisor and Principal Investigator. Responsibilities include meticulous adherence to study protocols, managing data collection activities, maintaining precise participant records, and collaborating with the team to ensure project success in alignment with stringent regulatory guidelines. The role may require a flexible schedule, including evenings, weekends, and travel to accommodate study needs. Responsible for overseeing all aspects of the day-to-day management of assigned projects. Serves as the primary administrative liaison between study participant and Principal Investigator or other research staff. Coordinates project activities, scheduling, and outreach. Attends or facilitates meetings and other communications with investigators, research sponsors, other research staff and investigator staff members for the purposes of coordination of services to support assigned research projects. Performs implementation/active and close-out phases of the study and recruitment of study participants by implementing effective screening strategies. Schedules and performs initial contact with prospective research subjects and follow-up visits; understands and explains research protocol, consent forms and when applicable uses detailed questionnaires and/or assessments to collect data for research studies; monitors the information for eligibility for the specific protocol as well as accuracy and completeness prior to examination by the investigators and/or sponsoring agency. Collects, codes and enters study information into a database; assists in data compilation. Documents and maintains accurate records and study information. Prepares reports and summaries as needed. Manages financial records for dissemination and reconciliation of participant incentives (i.e., Visa gift cards and/or other non-monetary gifts). Interviews project participants individually or in groups. Interviews may be conducted in person, by telephone, via televideo, or by mail. Ensures that completed questionnaires are complete, legible and accurate in accordance with research protocols. Make follow-up contact with participants to obtain missing or questionable data. Spearheads lab recruitment efforts as needed and coordinates the scheduling of required laboratory tests and/or exams when applicable. Process samples for shipping, and perform any other procedures specific to study protocols (willing to learn phlebotomy for the collection of blood samples as well as other biological or environmental samples, as well as collection of vital signs if needed); Operates and maintains clinical research laboratory equipment to ensure safety and provide accurate results. Develops, monitors, and adheres to timelines for project goals. Ensures that deadlines and deliverables to relevant funding agencies are met. Assist Clinical Research Supervisor and PI in complying with all state and federal regulatory and institutional requirements. Maintains complete and accurate records and files pertaining to one or more research studies including regulatory and financials (study supplies, equipment, research participant incentives, travel, etc.). Maintain detailed records of research subject visits and procedures. Makes descriptive reports of research study progress and outcomes. Makes recommendations to investigators to improve research processes and outcomes. Assists in preparation and submission of adverse events, protocol deviations or variations and data reports as needed. Responds to internal and external regulatory and financial audits. Demonstrates effective communication skills; communicates accurate and complete information, maintains strict confidentiality. Demonstrates exceptional customer service and positive working relationships with participants, co-workers, clinical and management team, ancillary departments, community partners and stakeholders.
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