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.
Develop study protocols, CRFs, and other study documents.
Develop instructional regulatory body (IRB) protocols, amendments and other documents as well as respond to IRB stipulations and requirements.
Collect, archive subjectsâ™ data. Assist in scientific data dissemination. Develop, write, edit, submit and publish scientific manuscripts and present scientific abstract at national and international conferences.
Participate in local and national meetings related to multi center trials and participate in regular phone/skype meetings related to clinical research.
Assist in developing and submitting regular progress reports to NIH and other sponsors of clinical research studies.
Applies research principles and relevant subject matter knowledge relevant to administer a research project. With a moderate level of direction, manages lab and/or research-related duties and tasks. Helps develop, design and conduct research projects according to plan.
Supports data collection and analytical needs of research projects. Conducts literature reviews and helps write reports and manuscripts. Ensures project compliance with different policies, procedures, directives, and mandates.
Performs other related work as needed.
Preferred Qualifications
Education:
 Advanced degree in research or related field.
Experience:
Experience with clinical trials.
Experience with IRB protocols.
Experience in women reproductive health studies.
Preferred Competencies
Organization.
Problem-solving.
Collaboration.
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.
Analytical skills.
Working Conditions
Outpatient clinical environment (primarily) and lab environment.
Ability to stand for extended periods.
Ability to use computer for extended periods.
Application Documents
Resume (required)
Cover Letter (preferred)
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