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Actively coordinates clinical research study activity, including screening, consenting and enrolling study participants. Performs a variety of duties involved in the collection, documentation, and reporting of clinical research data. Prepares IRB submissions/amendments. Monitors studies for adverse events and protocol violations; if any occur, reports finding to IRB in a timely and professional manner. Completes monthly progress reports, as well as biannual reports, to keep stakeholders informed of study’s progress. Assists with grant writing, article writing. Occasional late work day will be necessary. Occasional travel to satellite locations may be required.
Working knowledge of data entry/computers
Exceptional organizational skills
Effective interpersonal and interviewing skills
Familiarity with basic protocol procedures
Prior exposure and interviewing of high risk participants
Knowledge of the principles of research design
Organizational and analytical skills
Attentiveness to detail
Ability to maintain confidentiality
Bachelor’s degree or equivalent experience in a related field; supplemented with three (3) years of related work experience, including two (2) years of management experience.
Recruits, screens and enrolls study participants; confers with participants to explain purpose of study and obtain informed consent; administers/scores interviews, questionnaires and surveys; performs basic evaluation and interpretation of collected data and prepares appropriate reports and documentation as necessary; tracks participants over time and completes follow up assessments as specified in study protocol; collaborates with community partners as necessary to ensure participants well-being.
Evaluates and interprets collected clinical data in conjunction with PI as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same. Responsible for reporting any adverse events or protocol violations to the IRB as required.
Completes IRB submissions such as renewals and amendments. Performs data entry from information gathered for the study. Performs basic data analyses to check the integrity of data enteres (“data cleaning”). Assists in grant reporting preparation/tracking (completes semi-annual and annual reports for Federal funding agencies—HHS-ACF). Performs other duties as assigned.
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