1) 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.
2) 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.
3) Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
4) Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.
5) Performs other related work as needed.
6) Develop study protocols, CRFs, and other study documents.
7) Develop instructional regulatory body (IRB) protocols, amendments and other documents as well as respond to IRB stipulations and requirements.
8) 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.
9) Participate in local and national meetings related to multi center trials and participate in regular phone/skype meetings related to clinical research.
10) Assist in developing and submitting regular progress reports to NIH and other sponsors of clinical research studies.
11) Occasional Travel required.
1) Organization skills.
3) Collaboration skills.
4) Attention to detail.
5) Ability to work autonomously.
6) Proficiency in Microsoft Office, including Outlook, Excel, Word and PowerPoint.
7) Basic computer proficiency.
8) Knowledge in relevant scientific field.
9) Knowledge of research techniques or methods.
10) Knowledge of regulatory policies and procedures.
11) Analytical skills.Â
1) Advanced degree in research or a related field.
1) Previous clinical trials experience.
2) Previous IRB protocol experience.
3) Experience in women reproductive health studies.
1) Cover Letter
2) Curriculum Vita
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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