This is related to not only new drug development but also behavioral or psychosocial interventions. 2, 3, 4, 5 Assuring diversity in clinical trials enrollment is essential for eliminating health disparities as low enrollment and participation of racial/ethnic minorities and underserved patients affects the generalizability of research results for these groups. Federal policies and national and local educational initiatives have supported programs and research mandates for assuring diversity in clinical trials participation, yet lower participation of racial/ethnic minorities and underserved patients in clinical trials continues to exist. 1, 2 While the proportion of cancer patients participating in trials generally is low, enrollment is even lower for racial/ethnic minorities and rural communities. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.Clinical trials have produced advances in disease prevention, treatment and rehabilitation for many diseases, including cancer. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
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Actalent promotes consultant care and engagement through experiences that enable continuous development. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Every day, our experts around the globe are making an impact. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. US or foreign MD preferred Excellent Communication Skills Client Facing Work SAE Case ProcessingĪctalent connects passion with purpose. Manage and process all SAEs as per project specific instructions Document Control: maintain electronic files for department, perform file case searches, maintain file room for the department and use department databases to track, manage and control issued documents assign various tracking numbers Track and process assigned pharmaceutical and Data Management Center (DMC) queries Assist in the preparation of contract-required reports Generate specified data reports from the safety database as requested Process and edit safety narratives for IND and Non-IND Adverse Event (AE) cases as required Distribute Safety Information according to project specific requirements Assist in processing of MedDRA coding tasks Perform QC on AE submissionsĭrug safety, Medical Degree, adverse event reporting, pharmacovigilance, safety, clinical trial, pharmaceuticalĭrug safety,Medical Degree,adverse event reporting
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Responsibilities Performs various tasks in support of clinical research including adverse event analysis and processing serious adverse event reconciliation preparation of IND safety reports for submission to the FDA safety document or data analysis clinical trial site support reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary may review experimental protocols and informed consent documents and prepares, reviews, and edits presentations regarding safety issues.