HEALTH MANAGEMENT COMPANY - SAFETY SPECIALIST - EXCELLENT CAREER OPPORTUNITY - $15 HRLY - START NOW!

Essential Duties and ResponsibilitiesCoordinates the collection, review, and processing of safety related documents (SAE Report forms, IND Safety Reports, and Investigator Drug Brochures) associated with the conduct of clinical research trials.  Ensures that these tasks are conducted in adherence with SOPs and protocol specific reporting requirements. Enters information from safety related documents (SAE Report forms, IND Safety Reports, and Investigator Drug Brochures) into applicable tracking databases. Submits safety related documents (SAE Report forms, IND Safety Reports, and Investigator Drug Brochures) to the IRB for review. Communicates and collaborates with sponsor/CRO representatives and other personnel as necessary to resolve issues pertaining to safety related documents (SAE report forms, IND Safety Reports, and Investigator Drug Brochures) prior to and during the conduct of clinical research trials. Maintains safety related documentation within central regulatory files in accordance with applicable federal/international regulations and SOPs. Interacts with data management teams (sponsor/CRO) and applicable research site personnel as required to help resolve discrepancies between the clinical and safety database information. Provides education and training to sponsor/CRO representatives and other personnel regarding policies and procedures pertaining to safety related documentation. Helps to facilitate study investigator oversight through company processes, such as preparing/submitting items for  faxing SAE Reports for study investigator review, and issuing toxicity reports for study investigator review.

 

Minimum Qualifications

 6 months research experience or administrative support  in a medical field required.

CompetenciesExcellent organizational, communication, and customer service skills. Basic computer skills, including MS Excel and MS Word.