Title: Narrative Writer
Duration: 6 Months
100 % Remote
· Receive, triage, review and process data from various sources on time, within budget and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of primary review.
· Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, and investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local offices to facilitate expedited reporting.
· Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.
· Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
· Assist operations team with tasks, provide for back-up to the operations team, assist in generation of status reports, providing project metrics, drafting project instructions/guidelines and assist in implementation of new processes.
· Contribute under guidance of senior staff to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate.
· Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
· Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
· May liaise with client in relation to details on day to day process of cases.
· Perform operational and collaborative LSM task as directed by Lifecycle Safety Infrastructure.
· Ensure compliance to high quality standards and work with LSM constructively in a matrix framework to achieve project and customer deliverables.
· Executes administrative operational tasks as required e.g. committee and laboratory management.
· Collaborate with SO and LSM to help achieve operational departmental goals i.e. understands metrics appropriate to quality document management and assist in the achievement of productivity utilization and realization metrics.
· Read and acknowledge all necessary standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
· Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
· Working knowledge of Lifecycle Safety services. Familiarity with functionality of the Regulatory Database and Endpoint Tracking Database.
· Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
· Ability to meet strict deadlines; manage competing priorities and changing demands.
· Sound organization and time management skills.
· Ability to follow instructions/guidelines, work independently and on own initiative.
· Good attention to detail and accuracy and maintain high quality standards.
· Demonstrate good IT skills.
· Effective written and verbal communication skills.
· Ability to be flexible and receptive to changing process demands.
· Willingness and aptitude to learn new skills across Lifecycle Safety service lines.
· Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
· High School Diploma with 5 years’ relevant experience or Bachelor’s Degree in scientific or healthcare discipline or equivalent combination of education, training and experience.
· Extensive use of keyboard requiring repetitive motion of fingers.
· Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
· Regular sitting for extended periods of time.
· May require occasional travel.