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Veristat is expanding our presence internationally from our home office outside Boston to Montreal, Toronto, Research Triangle Park, Michigan, Taiwan, and most recently the United Kingdom. We do things differently than large CROs. Do you value scientific integrity and a collaborative team environment? If so, you will feel right at home here with dedicated opportunities to discuss your achievements and grow your career through quarterly managerial conversations. The Clinical Documentation Specialist provides administrative and technical support for assigned projects during any and all phases of the project (planning, initiation, monitoring, data management and reporting). S/he must be able to anticipate the needs of a study team and prioritize their workload and schedules to meet these needs.
• Support the audit and inspection readiness of assigned Trial Master Files (TMFs) by filing/uploading TMF documents in accordance with SOPs, current DIA model and study-specific guidelines, and within designated timelines • Contribute to the quality of the TMF by performing quality control checks of the filing/metadata for TMF documents • Support the completeness of assigned TMFs through the regular generation of TMF status reports • Using a study training matrix, maintain study specific training documentation for internal project team members and escalate non-compliance • Process site payments using the Clinical Trial Management System • Prepare and distribute agenda and minutes for study team and client technical meetings • When needed, participate in user acceptance testing of clinical systems • Provide general administrative support including organizing events and special projects, and other miscellaneous duties as assigned. • Assist in preparation for sponsor or internal audit and/or regulatory inspections.
• Advanced proficiency in computer skills (Microsoft Word, Excel, Project) • Possesses the ability to be flexible and take direction, and a positive attitude • Good interpersonal and communication skills. • Must be detail-orientated, motivated to work in a fast-paced environment, and able to effectively handle confidential matters. • Ability to handle multiple tasks and to establish priorities and meet tight deadlines. • English language proficiency (verbal & written) required.
• Bachelor’s degree in a relevant field preferred. • Minimum of 6 months’ administrative experience or experience in a health care related industry required. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis.
• Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years' experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared nearly 100 marketing applications for approval with global regulatory authorities in the last ten years. • Veristat's focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, cell and gene therapies, oncology, and infectious disease trials. We apply this knowledge base every day to solve any clinical program's challenges, from the simplest to the complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving lives.
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