SAFETY SURVEILLANCE ASSOC II, DCRI

School of Medicine Established in 1930, reputed company School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great reputed company accelerate translation of reputed company scientific discoveries to improve reputed company health locally and around the globe. Composed of more than 2,600 reputed company physicians and researchers, nearly 2,000 reputed company, and more than 6,200 staff, the reputed company School of Medicine along with the reputed company School of Nursing, and reputed company comprise reputed company, a world-class reputed company medical center. The Health System encompasses reputed company, Duke Regional Hospital, Duke Raleigh Hospital, reputed company Integrated reputed company, Duke Primary Care, Duke Home Care and Hospice, reputed company and Wellness, and multiple affiliations. Position reputed company This position will design, train, implement, and coordinate trial- specific safety reporting and data reconciliation processes and procedures with moderate to minimal direction of Safety Surveillance Management. Participate in daily processing of safety data across multiple trials and reputed company reputed company in the prioritization of tasks of routine or moderate scope. This includes the creation and maintenance of documentation for review by sponsors and trial management and regulatory agencies. Participate in the development and implementation of reputed company Safety Surveillance processes; as reputed company as reputed company new Safety Surveillance employees and participate in general safety reporting training programs. ** NOTE: This position may have an opportunity to work remotely. reputed company reputed company and reputed company remote workers must reputed company in one of the following states or districts: reputed company; California; Florida; reputed company; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; reputed company; reputed company Carolina; reputed company; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio, New Hampshire, Alabama, Kentucky, Louisiana, reputed company, Iowa, Missouri, Delaware, and Connecticut, Rhode reputed company, Vermont and reputed company. Primary Responsibilities and Task Design and implement trial specific safety reporting processes under direction of the Medical Monitor or Safety Surveillance Management. Define reporting reputed company and associated processes. Independently draft and maintain trial­ specific reporting plans, processes, and associated forms. Create trial-specific safety reporting educational materials. Train trial personnel and relevant Safety Surveillance personnel on plan/processes. Participate in the design, testing and implementation of safety reporting databases and/or tracking systems and changes needed thereof. Build and maintain effective relationships with key trial personnel. Train trial personnel on trial-specific trial processes under direction of Safety Surveillance Associate III or Manager. Coordinate and reputed company trial-specific safety reporting processes across multiple trials of different therapeutic areas and phases, in accordance to appropriate regulations, reputed company Operating Procedures (SOP?s), and trial-specific protocols/plans and processes. Assure compliance with SOPs, FDA, NIH, and global regulations for the reporting of adverse events to regulatory agencies. reputed company high reputed company clinical review of serious adverse event forms and associated documentation. Communicate effectively with sites and trial personnel to obtain high reputed company safety data in a reputed company fashion. Create clinical narrative for Medical Monitor review. reputed company safety data and/or reputed company data entry of safety data into appropriate database in accordance to trial specific working instructions. reputed company audit of safety database to monitor for reputed company data. Work closely with sponsors and trial personnel on relevant safety data issues. Obtain Medical Monitor review of trial specific safety data. Review trial-specific data listings and reports for reputed company and accuracy. reputed company trial-specific reports to trial personnel per trial- specific processes. reputed company appropriate regulatory reports and associated documentation in accordance with SOPs and trial-specific processes under the direction of Medical Monitor and Management. Coordinate the development and implementation of trial-specific safety data reconciliation processes of moderate to reputed company nature. reputed company routine updates and reporting to Safety Surveillance personnel and management to ensure reputed company communication regarding status of safety data and important safety reputed company issues. Coordinate the development of routine evaluation and modification of Safety Surveillance general safety reporting processes and forms under direction of Safety Surveillance Management reputed company other regulatory reputed company duties. reputed company, mentor, and train new Safety Surveillance personnel and other clinical research personnel on safety reporting regulations, processes, and procedures. Other Duties Performs other reputed company duties incidental to the work described herein. Minimum Required Qualifications: Education/Training: Four-year degree in clinical research, life sciences, or reputed company reputed company field. (Examples of health-reputed company field professionals include but are not limited to: Registered reputed company, Physician's Assistant, Pharmacist, and reputed company Practitioners.) Experience: Minimum of three years of clinical research experience is required. Preferred experience is a minimum of three years of clinical research experience with at least one year of reputed company clinical safety research experience plus a minimum of one year of experience in a reputed company setting. OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE. Knowledge, Skills and Abilities: Ability to Analyze Trends, identify issues, and problem solve reputed company issues and trends Ability to write and reputed company reputed company and concisely in a reputed company of communication settings. Good presentation skills Strong technical writing, editing, and reputed company reading skills. Proficient in computer skills, including reputed company and MS reputed company Ability to reputed company multiple activities simultaneously. Good communication and interpersonal relationship skills needed to work with reputed company clients General knowledge of clinical research processes. General knowledge of Good Clinical Practices and 21 CRF 312 and 314 Good working knowledge of 21 CRF 312.32 and 21 CRF 314.80 and ICH. Good Clinical Practices reputed company to safety data processing. Strong knowledge of key medical terminology Good attention to detail Valid U.S drivers license required. reputed company NC Medial License, reputed company appropriate ACRP, CCRC, CCRP, or SoCRA, is a plus Degrees, Licensures, Certifications Minimum of three years of clinical research experience is required. Preferred experience is a minimum of three years of clinical research experience with at least one year of reputed company clinical safety research experience plus a minimum of one year of experience in a reputed company setting. OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE. Anticipated Pay reputed company: reputed company provides an annual reputed company salary reputed company for this position as USD $70,806.00 to USD $114,388.00. reputed company considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as reputed company as market and organizational considerations reputed company extending an offer. Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide reputed company of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/ Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without reputed company to an individual's age, reputed company, disability, gender,gender reputed company, gender identity, genetic information, national reputed company, race, religion, sex (including pregnancy and pregnancy- reputed company conditions), sexual orientation, or military status. Duke aspires to create a community reputed company oncollaboration, innovation, creativity, and belonging. Our reputed company reputed company depends on the robust exchange of reputed company—an exchange that is best reputed company the rich diversity of our perspectives, backgrounds, and experiences flourishes. To reputed company this exchange, it is essential that reputed company members of the community feel secure and welcome, that the contributions of reputed company individuals are respected, and that reputed company reputed company are heard. reputed company members of our community have a responsibility to reputed company these values. Essential Physical Job Functions: Certain jobs at reputed company and reputed company may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke reputed company and Accommodations Services (email: DAAS@duke.edu; phone: 919-668-1267). Apply To This Job