Develops study protocols, CRFs, and other study documents.
Develops instructional regulatory body (IRB) protocols, amendments and other documents as well as respond to IRB stipulations and requirements.
Collects, archives subjectsâ™ data. Assists in scientific data dissemination. Develops, writes, edits, submits and publishes scientific manuscripts and presents scientific abstract at national and international conferences.
Participates in local and national meetings related to multi center trials and participates in regular phone/skype meetings related to clinical research.
Assists in developing and submitting regular progress reports to NIH and other sponsors of clinical research studies.
This job provides technical and administrative support in a laboratory environment performing basic laboratory techniques, research and analysis under direction.
Provides routine or standardized laboratory duties by collecting data in support of research projects under direct supervision.
Collects and enters data. Assists in analysis of data and with preparation of reports, manuscripts and other documents.
Complies with institution, state and federal regulatory policies, procedures, directives, and mandates.
Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, subject consenting, subject recruitment, perform and supervise various study visit procedures, and participation in program audits.
Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.
Performs other related work as needed.
Â Advanced degree in research or a related field.
Experience with clinical trials.
Experience with IRB protocol.
Experience in women reproductive health studies.
Attention to detail.
Ability to work autonomously.
Proficiency in Microsoft Office, including Outlook, Excel, Word and PowerPoint.
Basic computer proficiency.
Knowledge in relevant scientific field.
Knowledge of research techniques or methods.
Knowledge of regulatory policies and procedures.
Outpatient clinical environment.
Ability to stand for extended periods.
Ability to use computer for extended periods.
Cover Letter (preferred)
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