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School of Medicine Established in 1930, Duke University 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 ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Position Summary

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 lead the team 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 standard Safety Surveillance processes; as well as precept new Safety Surveillance employees and participate in general safety reporting training programs.

** NOTE: This position may have an opportunity to work remotely.  All Duke University and Duke Health remote workers must reside in one of the following states or districts:  Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio, New Hampshire, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut, Rhode Island, Vermont and Wisconsin.

 

Primary Responsibilities and Task

Design and implement trial specific safety reporting processes under direction of the Medical Monitor or Safety Surveillance Management. Define reporting criteria 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 perform trial-specific safety reporting processes across multiple trials of different therapeutic areas and phases, in accordance to appropriate regulations, Standard 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. Perform high quality clinical review of serious adverse event forms and associated documentation. Communicate effectively with sites and trial personnel to obtain high quality safety data in a timely fashion. Create clinical narrative for Medical Monitor review. Enter safety data and/or oversee data entry of safety data into appropriate database in accordance to trial specific working instructions. Perform audit of safety database to monitor for quality 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 quality and accuracy. Provide trial-specific reports to trial personnel per trial- specific processes.

Develop 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 complex nature.

Provide routine updates and reporting to Safety Surveillance personnel and management to ensure timely communication regarding status of safety data and important safety related issues.

Coordinate the development of routine evaluation and modification of Safety Surveillance general safety reporting processes and forms under direction of Safety Surveillance Management

Perform other regulatory related duties.

Precept, mentor, and train new Safety Surveillance personnel and other clinical research personnel on safety reporting regulations, processes, and procedures.

Other Duties

Performs other related duties incidental to the work described herein.

 Minimum Required Qualifications:

 

Education/Training: 

Four-year degree in clinical research, life sciences, or healthcare related field.

(Examples of health-related field professionals include but are not limited to: Registered Nurse, Physician's Assistant, Pharmacist, and Nurse 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 direct clinical safety research experience plus a minimum of one year of experience in a healthcare 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 complex issues and trends Ability to write and speak clearly and concisely in a variety of communication settings.

Good presentation skills Strong technical writing, editing, and proof reading skills. Proficient in computer skills, including MS Word and MS Excel Ability to perform multiple activities simultaneously.

Good communication and interpersonal relationship skills needed to work with internal and external 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 related to safety data processing.

Strong knowledge of key medical terminology Good attention to detail Valid U.S drivers license required.

Professional NC Medial License, when 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 direct clinical safety research experience plus a minimum of one year of experience in a healthcare setting. OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.