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The University of Miami/UHealth Department of Psychiatry has an exciting opportunity for a full time Clinical Research Coordinator 2 to work in Miami, FL.
The Clinical Research Coordinator 2 (CRC 2) will report to the Department Chair and serve as the Clinical Coordinator for the Tics, OCD and Related Disorders Program at the UHealth Tourette Association of America (TAA) Center of Excellence. The incumbent will conduct thorough phone calls with patients and properly triage patients, maintain a calendar on behalf of the Chair, and provide routine and general clerical support or medical-related support which may be related to both patient care and research. Additionally, the incumbent will observe and receive direct training and supervision to assist with patients. The CRC 2 will assist in collecting histories of new patients and performing assessments under the supervision of the Chair and other team specialists. The CRC2 will assist in referral of eligible clinic patients to appropriate research related studies and activities.
S/he will organize and arrange community activities to advance the goals and aims of the Tourette Association of America (TAA) Center of Excellence including a speaker series and trainings. Additionally, the incumbent will assist the Department Chair with document preparation for new grant submissions as well as related tasks such as performing literature reviews, article submissions to various academic journals, chart reviews, data analysis, and Power-point and poster presentations.
In addition, the incumbent will handle the process of conducting research studies and related projects, including coordination of activities of research projects both interventional and observational, study participant related activities such as recruitment, screening, assessments, follow-up assessments, data collection and management using electronic data capture systems, interaction with patient’s treatment team, and preparation of participant reimbursements. The CRC 2 will ensure that the study is conducted according to protocol design and will report deviations as they arise, and maintain study files such as regulatory documents, correspondence, case report forms and data files – in compliance with all regulatory requirements and in accordance with Good Clinical Practice. S/he will perform activities related to regulatory compliance such as IRB submissions, mandates issued by the study sponsor, and any other regulatory entity.
Additionally, the CRC2 will work closely with the Chair’s Executive Assistant on coverage of Department clinical administrative matters.
Core responsibilities:
Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
Maintains study binders and filings according to protocol requirements, UM and department policy.
Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
Assists with study orientation and protocol related in-services to research team and clinical staff.
Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
Learns…